Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00498706
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 325
• Location: 1
• Arms: 2
• Duration (Months): 53
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

This study will compare the effectiveness of telephone versus face-to-face administration of cognitive behavioral therapy in treating people with depression.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT); Behavioral: Face-to-face administered CBT (FtF-CBT)	Phase 3

Detailed Description

Major depressive disorder is a common and often long-lasting disorder with 12-month prevalence rates estimated to be between 6.6% and 10.3%. Although the personal and societal costs of depression are high, it is well established that depression can be effectively treated using antidepressant medication and/or forms of psychotherapy. Several studies have found that when given a choice, about two-thirds of depressed patients prefer psychotherapy or counseling over antidepressant medication. However, a variety of barriers exist to initiating and maintaining psychotherapy. Only about 20% of all patients referred for psychotherapy actually initiate treatment, and of those who do initiate treatment, nearly half drop out before completing treatment. The use of the telephone to deliver treatment services has been recommended as a way to reduce many of the barriers associated with failure to initiate and sustain treatment. When administered over the telephone, cognitive behavioral therapy (CBT), a form of psychotherapy that teaches ways to modify thoughts and behaviors that contribute to depression, may be superior to face-to-face CBT in improving treatment adherence and reducing depressive symptoms. This study will compare the effectiveness of telephone CBT (T-CBT) versus face-to-face CBT (FtF-CBT) in treating people with depression.

Participation in this study will include 18 weeks of treatment and 12 months of follow-up. All participants will first undergo baseline assessments that will include a telephone interview and questionnaires about mood. Participants will then be assigned randomly to receive T-CBT or FtF-CBT. Participants in both groups will receive eighteen 45-minute sessions of their assigned treatment over 18 weeks. Sessions will occur twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. During sessions, participants will learn ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made. Treatment sessions will be identical for both groups, except one group will receive sessions over the telephone and the other in-person at a study office. All participants will repeat the baseline assessments at Weeks 4, 9, 14, and 18 of treatment and Months 3, 6, 9, and 12 of follow-up.

Study Design

• Study Type: Interventional
• Actual Enrollment: 325 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Telephone Versus Face-to-Face Administration of CBT for Depression
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telephone-administered CBT Participants will receive telephone-administered cognitive behavioral therapy.	Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT); Over 18 weeks, participants will receive eighteen 45-minute sessions of T-CBT administered by a therapist. Participants will undergo telephone-administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.
Active Comparator: Face-to-face CBT Participants will receive face-to-face cognitive behavioral therapy.	Behavioral: Face-to-face administered CBT (FtF-CBT); Over 18 weeks, participants will receive eighteen 45-minute sessions of FtF-CBT administered by a therapist. Participants will undergo face-to-face administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.

Outcome Measures

Primary Outcome Measures

1. Attrition (Number of Therapy Sessions Attended) [Post treatment, up to 18 weeks]

   Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.

2. Number of Participants Who Dropped Out of Therapy [Post treatment, up to 18 weeks]

   Using the number of therapy sessions attended, we categorized patients into: those who discontinued treatment before session 18, and those who completed session 18. those who discontinued before Session 5, and those who continued.

3. Patient Health Questionnaire (PHQ)-9 [Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up]

   Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment.

4. Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) [Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up]

   Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant.

Secondary Outcome Measures

1. Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form) [Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Has a current diagnosis of major depressive disorder

• Has a primary care physician at Northwestern University in Illinois, or one of a number of approved community clinics in Chicago.

• Resides in Illinois

• Has a telephone

• Speaks and reads English

Exclusion Criteria:

• Hearing, voice, or visual impairment

• Meets criteria for dementia

• Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous

• Currently receiving individual psychotherapy or planning to receive psychotherapy during the treatment phase of the study

• Planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time

• Recent history of suicide attempts or is severely suicidal

• Initiated treatment with an antidepressant in the 2 months before study entry (antidepressant medication is not exclusionary)

• Depression determined to be primarily of an organic etiology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: David C. Mohr, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Mohr, Professor, National Institute of Mental Health (NIMH)
• ClinicalTrials.gov Identifier: NCT00498706
• Other Study ID Numbers: R01MH059708; R01MH059708
• First Posted: Jul 10, 2007
• Last Update Posted: Jul 17, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by David Mohr, Professor, National Institute of Mental Health (NIMH): Depressive Disorder, Major; Cognitive Behavioral Therapy; Psychotherapy; Telemedicine; Primary Care
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

Recruitment Details	Participants were recruited from November 2007 to December 2010 from general internal medicine clinics in Northwestern Medical Faculty Foundation and Northwestern Memorial Physician's Group, and from 4 primary care clinic members of Northwestern's Practice-Based Research Network.

Arm/Group Title	Telephone-administered CBT	Face-to-face CBT
Arm/Group Description	Participants will receive telephone-administered cognitive behavioral therapy.	Participants will receive face-to-face cognitive behavioral therapy.
Period Title: Overall Study
STARTED	163	162
Post Treatment Week 18	163	162
COMPLETED	163	162
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Telephone-administered CBT	Face-to-face CBT	Total
Arm/Group Description	Participants will receive telephone-administered cognitive behavioral therapy.	Participants will receive face-to-face cognitive behavioral therapy.	Total of all reporting groups
Overall Participants	163	162	325
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	150 92%	148 91.4%	298 91.7%
>=65 years	13 8%	14 8.6%	27 8.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.8 (12.6)	47.5 (13.5)	47.6 (13.1)
Sex: Female, Male (Count of Participants)
Female	125 76.7%	127 78.4%	252 77.5%
Male	38 23.3%	35 21.6%	73 22.5%
Region of Enrollment (participants) [Number]
United States	163 100%	162 100%	325 100%

Outcome Measures

1. Primary Outcome

Title	Attrition (Number of Therapy Sessions Attended)
Description	Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.
Time Frame	Post treatment, up to 18 weeks

Outcome Measure Data

Analysis Population Description

A randomized controlled trial of 325 Chicago area primary care patients with major depressive disorder, recruited from November 1007 to December 2010.

Arm/Group Title	Telephone-administered CBT	Face-to-face CBT
Arm/Group Description	Participants will receive telephone-administered cognitive behavioral therapy.	Participants will receive face-to-face cognitive behavioral therapy.
Measure Participants	163	162
Measure sessions	2518	2221
Mean (Standard Deviation) [Number of Sessions]	15.4 (4.4)	13.7 (6.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telephone-administered CBT, Face-to-face CBT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	t value
	Estimated Value	-2.95
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Number of Participants Who Dropped Out of Therapy
Description	Using the number of therapy sessions attended, we categorized patients into: those who discontinued treatment before session 18, and those who completed session 18. those who discontinued before Session 5, and those who continued.
Time Frame	Post treatment, up to 18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Telephone-administered Cognitive Behavioral Therapy	Face-to-face Cognitive Behavioral Therapy
Arm/Group Description	Participants will receive telephone-administered cognitive behavioral therapy.	Participants will receive face-to-face cognitive behavioral therapy.
Measure Participants	163	162
those who discontinued treatment before session 18	34 20.9%	53 32.7%
those who discontinued before Session 5,	7 4.3%	21 13%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telephone-administered CBT, Face-to-face CBT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Chi-square
	Estimated Value	5.83
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Telephone-administered CBT, Face-to-face CBT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.006
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Chi-square
	Estimated Value	7.75
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Attrition before week 5 was significantly lower in T-CBT than in face-to-face CBT.

3. Secondary Outcome

Title	Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)
Time Frame	Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Primary Outcome

Title	Patient Health Questionnaire (PHQ)-9
Description	Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment.
Time Frame	Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Telephone-administered CBT	Face-to-face CBT
Arm/Group Description	Participants will receive telephone-administered cognitive behavioral therapy.	Participants will receive face-to-face cognitive behavioral therapy.
Measure Participants	162	163
Baseline	16.76 (4.7)	16.76 (4.8)
Week04	10.78	10.09
Week09	9.05	8.62
Week14	8.55	7.77
Week18	6.65	6.74
3-month follow-up	7.59	6.60
6-month follow-up	8.42	6.30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telephone-administered CBT, Face-to-face CBT
	Comments	Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95%; -1.35 to 1.17
	Parameter Dispersion	Type: Standard Deviation; Value: 1.26
	Estimation Comments

5. Primary Outcome

Title	Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)
Description	Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant.
Time Frame	Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Telephone-administered CBT	Face-to-face CBT
Arm/Group Description	Participants will receive telephone-administered cognitive behavioral therapy.	Participants will receive face-to-face cognitive behavioral therapy.
Measure Participants	163	162
Baseline	22.83 (4.6)	22.83 (4.6)
Week04	18.07	17.86
Week09	15.62	16.45
Week14	14.94	14.18
Week18	13.58	12.51
3-month follow-up	14.58	12.33
6-month follow-up	15.06	12.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telephone-administered CBT, Face-to-face CBT
	Comments	Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.
Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; -0.63 to 2.76
	Parameter Dispersion	Type: Standard Deviation; Value: 1.695
	Estimation Comments

Adverse Events

Arm/Group Title	Telephone-administered CBT		Face-to-face CBT
Arm/Group Description	Participants will receive telephone-administered cognitive behavioral therapy.		Participants will receive face-to-face cognitive behavioral therapy.
All Cause Mortality
	Telephone-administered CBT		Face-to-face CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Telephone-administered CBT		Face-to-face CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/163 (0%)		0/162 (0%)
Other (Not Including Serious) Adverse Events
	Telephone-administered CBT		Face-to-face CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/163 (0%)		0/162 (0%)

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.