A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression

• Sponsor: National Center for Telehealth and Technology (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01599585
• Collaborator: VA Office of Research and Development (U.S. Fed)
• Enrollment: 121
• Locations: 2
• Arms: 2
• Duration (Months): 53
• Patients Per Site: 60.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and depression as in-person BA treatment for depression.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Behavioral Activation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of In-Home Tele-behavioral Health Care Utilizing Behavioral Activation for Depression
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: In Home Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.	Behavioral: Behavioral Activation; Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.; Other Names: BA
Active Comparator: In-Person Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.	Behavioral: Behavioral Activation; Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.; Other Names: BA

Outcome Measures

Primary Outcome Measures

1. Beck Hopelessness Scale (BHS) [Post treatment - Week 8]

   The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.

Secondary Outcome Measures

1. Adverse Events [Treatment Session Week 1]

   Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.

2. Beck Depression Inventory -II (BDI-II) [Baseline]

   The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.

3. Adverse Events [Treatment Session Week 2]

   Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.

4. Adverse Events [Treatment Session Week 3]

   Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.

5. Adverse Events [Treatment Session Week 4]

   Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.

6. Adverse Events [Treatment Session Week 5]

   Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.

7. Adverse Events [Treatment Session Week 6]

   Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.

8. Adverse Events [Treatment Session Week 7]

   Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.

9. Adverse Events [Treatment Session Week 8]

   Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.

10. Adverse Events [3 month follow up]

    Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.

11. Beck Depression Inventory -II (BDI-II) [Midpoint- Week 4]

    The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome

12. Beck Depression Inventory -II (BDI-II) [Post Treatment- Week 8]

    The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.

13. Beck Depression Inventory -II (BDI-II) [3 month follow up]

    The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.

14. Beck Hopelessness Scale (BHS) [Baseline]

    The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.

15. Beck Hopelessness Scale (BHS) [Midpoint- Week 4]

    The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.

16. Beck Hopelessness Scale (BHS) [3 month follow up]

    The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Current Major Depressive or Minor Depressive Disorder

• High-speed internet/network access at home (384kbs minimum)

• Informed consent

• Fluent in the English language

Exclusion Criteria:

• Currently undergoing psychotherapy for depression

• less than 18 or greater than 65 year of age

• Active psychotic symptoms/disorders as determined by the SCID for DSM-IV

• Dysthymic Disorder

• Current suicidal ideation with intent or recent (within six months) history of a suicide attempt

• History of Organic Mental Disorder

• Current substance dependence as determined by the SCID (lifetime substance dependence or substance abuse will not be excluded)

• History of violence or poor impulse control causing potential risk to staff or others

• Significant ongoing stressors that require urgent crisis intervention

• Having a living arrangement that will not permit the use of a private space to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Portland VA Medical Center	Portland	Oregon	United States	97207
2	National Center for Telehealth and Technology	Tacoma	Washington	United States	98431

Sponsors and Collaborators

• National Center for Telehealth and Technology
• VA Office of Research and Development

Investigators

• Principal Investigator: Gregory A Gahm, PhD, National Center for Telehealth and Technology
• Principal Investigator: David D Luxton, PhD, National Center for Telehealth & Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ajzen, I. From intentions to actions: A theory of planned behavior. In J. Khul and J. Beckman (Eds). Action-control: From cognition to behavior (pp. 11-39) Heidelberg, Springer. 1985
• Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7.
• Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97.
• Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5.
• Beck, AT, and Steer RA. Beck Hopelessness Manual. San Antonio, TX: The Psychological Corporation. 1988
• Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73.
• Cohen, J. Statistical power analysis for the behavioral sciences (2nd ed). Hillsdale, NJ, Lawrence Erlbaum Associates, 1988
• deJong Giervelde, J and Van Tilburg, TG. A six-item scale for overall emotional and social loneliness: Confirmative tests on a new survey data. Research on Aging, 28, 582-598, 2006.
• Egede LE, Frueh CB, Richardson LK, Acierno R, Mauldin PD, Knapp RG, Lejuez C. Rationale and design: telepsychology service delivery for depressed elderly veterans. Trials. 2009 Apr 20;10:22. doi: 10.1186/1745-6215-10-22.
• First, MB, Spitzer RL, Gibbon, M and Williams, JBW. Structured Clinical Interview for DSM-IV Axis Disorders. Arlington, VA: American Psychiatric Press. 2002
• Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Dávila-Román VG, Steinmeyer BC, Hogue CW Jr. Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Arch Gen Psychiatry. 2009 Apr;66(4):387-96. doi: 10.1001/archgenpsychiatry.2009.7.
• Hopko DR, Lejuez CW, LePage JP, Hopko SD, McNeil DW. A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. Behav Modif. 2003 Sep;27(4):458-69.
• Jacobson, NS, Martell, CR and Dimidjian, S. Behavioral activation therapy for depression: Returning to contextual roots. Clinical Psychology: Science and Practice 8(3):255-270, 2002
• King R. Cognitive therapy of depression. Aaon Beck, John Rush, Brian Shaw, Gary Emery. New York: Guilford, 1979. Aust N Z J Psychiatry. 2002 Apr;36(2):272-5. Review.
• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207.
• Lewinsohn PM, Graf M. Pleasant activities and depression. J Consult Clin Psychol. 1973 Oct;41(2):261-8.
• Lewinsohn, PM, Biglan, A, Zeiss, AS. Behavioral treatment of depression. The behavioral management of anxiety, depression and pain. (pp.91-46. New York; Bunner/Mazel
• Lewinsohn, PM, Gotlib, IH. Behavioral theory and treatment of depression. In E.E. Beckham and W.R. Leber (Eds). Handbook of depression (pp.352-375) New York: Guildford, 1995
• Luxton DD, Sirotin AP, Mishkind MC. Safety of telemental healthcare delivered to clinically unsupervised settings: a systematic review. Telemed J E Health. 2010 Jul-Aug;16(6):705-11. doi: 10.1089/tmj.2009.0179. Review.
• Mackenzie CS, Gekoski WL, Knox VJ. Age, gender, and the underutilization of mental health services: the influence of help-seeking attitudes. Aging Ment Health. 2006 Nov;10(6):574-82.
• Mackenzie, CS, Knox, VJ, Gekoski, WL and Macaulay, HL. An adaption and extension of the Attitudes Toward Seeking Professional Psychological Help Scale. Journal of Applied Social Psychology, 34, 2410-2435, 2004.

• Responsible Party: National Center for Telehealth and Technology
• ClinicalTrials.gov Identifier: NCT01599585
• Other Study ID Numbers: W81XWH-11-2-0118; W81XWH-11-2-0118
• First Posted: May 16, 2012
• Last Update Posted: Jun 16, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by National Center for Telehealth and Technology: Depression; Behavioral Activation; Tele-medicine
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Period Title: Overall Study
STARTED	62	59
COMPLETED	40	42
NOT COMPLETED	22	17

Baseline Characteristics

Arm/Group Title	In Home	In-Person	Total
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Total of all reporting groups
Overall Participants	62	59	121
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	62 100%	59 100%	121 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.8 (12.4)	35.6 (11.8)	35.1 (12.1)
Sex: Female, Male (Count of Participants)
Female	10 16.1%	12 20.3%	22 18.2%
Male	52 83.9%	47 79.7%	99 81.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 4.8%	7 11.9%	10 8.3%
Not Hispanic or Latino	56 90.3%	52 88.1%	108 89.3%
Unknown or Not Reported	3 4.8%	0 0%	3 2.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.6%	0 0%	1 0.8%
Asian	3 4.8%	1 1.7%	4 3.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 12.9%	10 16.9%	18 14.9%
White	44 71%	41 69.5%	85 70.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	6 9.7%	7 11.9%	13 10.7%
Region of Enrollment (participants) [Number]
United States	62 100%	59 100%	121 100%

Outcome Measures

1. Primary Outcome

Title	Beck Hopelessness Scale (BHS)
Description	The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time Frame	Post treatment - Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	45	42
Mean (Standard Deviation) [units on a scale]	4.888889 (4.642796)	4.428571 (4.939353)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	In Home, In-Person
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	One tailed test at .05a = .05 margin was set at standardized difference of .50
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Regression, Beta
	Estimated Value	0.40
	Confidence Interval	(2-Sided) 90%; .12 to .68
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Adverse Events
Description	Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame	Treatment Session Week 1

Outcome Measure Data

Analysis Population Description

AE data reported in adverse events section

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	62	59
Number [participants]	0 0%	0 0%

3. Secondary Outcome

Title	Beck Depression Inventory -II (BDI-II)
Description	The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	62	59
Mean (Standard Deviation) [units on a scale]	27.59678 (10.44652)	29.71186 (11.33054)

4. Secondary Outcome

Title	Adverse Events
Description	Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame	Treatment Session Week 2

Outcome Measure Data

Analysis Population Description

adverse event data reported in adverse event section

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	62	59
Number [participants]	0 0%	0 0%

5. Secondary Outcome

Title	Adverse Events
Description	Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame	Treatment Session Week 3

Outcome Measure Data

Analysis Population Description

adverse event data reported in adverse event section

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	62	59
Number [participants]	62 100%	59 100%

6. Secondary Outcome

Title	Adverse Events
Description	Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame	Treatment Session Week 4

Outcome Measure Data

Analysis Population Description

Adverse Event data recorded in Adverse event section

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	48	44
Number [participants]	0 0%	0 0%

7. Secondary Outcome

Title	Adverse Events
Description	Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame	Treatment Session Week 5

Outcome Measure Data

Analysis Population Description

adverse events are reported in adverse event section

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	48	44
Number [participants]	0 0%	0 0%

8. Secondary Outcome

Title	Adverse Events
Description	Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame	Treatment Session Week 6

Outcome Measure Data

Analysis Population Description

adverse events are reported in the adverse event section

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	48	44
Number [participants]	0 0%	0 0%

9. Secondary Outcome

Title	Adverse Events
Description	Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame	Treatment Session Week 7

Outcome Measure Data

Analysis Population Description

adverse events are reported in adverse event section

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	45	42
Number [participants]	0 0%	0 0%

10. Secondary Outcome

Title	Adverse Events
Description	Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame	Treatment Session Week 8

Outcome Measure Data

Analysis Population Description

Adverse event data recorded in adverse event section

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	45	42
Number [participants]	0 0%	0 0%

11. Secondary Outcome

Title	Adverse Events
Description	Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

Adverse event data is recorded in adverse event section

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	42	36
Number [participants]	6 9.7%	2 3.4%

12. Secondary Outcome

Title	Beck Depression Inventory -II (BDI-II)
Description	The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome
Time Frame	Midpoint- Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	47	44
Mean (Standard Deviation) [units on a scale]	19.40425 (11.77444)	20.20455 (13.09106)

13. Secondary Outcome

Title	Beck Depression Inventory -II (BDI-II)
Description	The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time Frame	Post Treatment- Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	62	59
Mean (Standard Deviation) [units on a scale]	13.82222 (12.01947)	11.7381 (12.07509)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	In Home, In-Person
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	One tailed test at .05a = .05 margin was set at standardized difference of .50
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Regression, Beta
	Estimated Value	.47
	Confidence Interval	(2-Sided) 90%; .16 to .78
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Beck Depression Inventory -II (BDI-II)
Description	The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	42	36
Mean (Standard Deviation) [units on a scale]	14.7619 (12.88752)	15 (12.61065)

15. Secondary Outcome

Title	Beck Hopelessness Scale (BHS)
Description	The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	62	59
Mean (Standard Deviation) [units on a scale]	9 (5.118273)	10.37288 (6.133285)

16. Secondary Outcome

Title	Beck Hopelessness Scale (BHS)
Description	The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time Frame	Midpoint- Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	48	44
Mean (Standard Deviation) [units on a scale]	7.041667 (5.63786)	7.954545 (6.261564)

17. Secondary Outcome

Title	Beck Hopelessness Scale (BHS)
Description	The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	In Home	In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Measure Participants	42	36
Mean (Standard Deviation) [units on a scale]	5.214286 (5.101582)	5.527778 (5.973686)

Adverse Events

Time Frame	Adverse events were collected from time of consent to final outcome assessment
Arm/Group Title	In Home		In-Person
Arm/Group Description	Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.		Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology. Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
All Cause Mortality
	In Home		In-Person
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	In Home		In-Person
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/62 (4.8%)		1/59 (1.7%)
Cardiac disorders
Severe chest pain	0/62 (0%)	0	1/59 (1.7%)	1
Immune system disorders
hospitalization for high fever and chills	1/62 (1.6%)	1	0/59 (0%)	0
Psychiatric disorders
exacerbation of baseline suicidality	1/62 (1.6%)	1	0/59 (0%)	0
Respiratory, thoracic and mediastinal disorders
exacerbation of asthma symptoms requiring hospitalization	1/62 (1.6%)	1	0/59 (0%)	0
Other (Not Including Serious) Adverse Events
	In Home		In-Person
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/62 (4.8%)		1/59 (1.7%)
General disorders
broken nose	1/62 (1.6%)	1	0/59 (0%)	0
syncopial episode	1/62 (1.6%)	1	0/59 (0%)	0
Musculoskeletal and connective tissue disorders
tore tendons in foot	1/62 (1.6%)	1	0/59 (0%)	0
broken finger	0/62 (0%)	0	1/59 (1.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.