iCBT: Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function

• Sponsor: Mclean Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01598922
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The purpose of this study is to understand the effectiveness of a ten-week internet-based cognitive behavioral therapy (iCBT) treatment on improving depressive symptoms, coping and resilience skills, and cognitive processing.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Behavioral: Internet Cognitive Behavioral Therapy	N/A

Detailed Description

The need for mental health services is high among military personnel but perceived stigma and other barriers prevent many Soldiers from obtaining the help they need. Alternative mental health treatment approaches that mitigate stigma and increase access and compliance are greatly needed. One promising treatment approach that has shown efficacy in preliminary research and which may address issues related to stigma and barriers to care, is internet-based cognitive behavioral therapy (iCBT). Internet-based treatments offer brief, interactive, and structured treatment approaches that can be completed by individuals relatively anonymously, in the convenience and privacy of their own homes, and according to their own schedules. Such interventions could offer Soldiers an alternative treatment method that minimizes stigma by allowing private and quasi-anonymous access to treatment and which minimizes barriers to care by enhancing access and maximizing schedule flexibility.

Emerging evidence suggests that iCBT is a particularly promising and well-accepted approach for treating large numbers of individuals while minimizing cost and clinicians' time demand. The study of internet-based and other computer-assisted therapies is currently in its infancy and most studies still lack sufficient methodological rigor to firmly establish the efficacy and applicability of these approaches. The proposed project will provide the most comprehensive evaluation of iCBT to date by employing functional neuroimaging techniques, neurocognitive testing of implicit negative biases and responses to negative feedback, and assessment of resilience and coping capacities in addition to standard symptom-based outcome measures.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: For the clinical trial there were only 2 arms: MDD and MAC. There were no Healthy Controls in the CBT vs attention monitoring trial; both groups were depressed.For the clinical trial there were only 2 arms: MDD and MAC. There were no Healthy Controls in the CBT vs attention monitoring trial; both groups were depressed.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
• Actual Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Internet Cognitive Behavioral Therapy Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program.	Behavioral: Internet Cognitive Behavioral Therapy; 8 weeks of online treatment program
No Intervention: Monitored Attention Control Participants with major depressive disorder receive no treatment but are monitored closely for 8 weeks. Participants in this arm are offered the treatment at the end of the study.

Outcome Measures

Primary Outcome Measures

1. Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). [Measured at the baseline visit and 10 weeks after the baseline visit]

   To assess change in severity of depression symptoms. The total score is reported, which is the sum of the ratings of all items and ranges from 0 to 52, with higher scores indicating a worse outcome or greater severity of depression symptoms.

Secondary Outcome Measures

1. Weekly Patient Health Questionnaire (PHQ-9) Score [Baseline visit, and 10 weeks after baseline visit]

   Participants' scores on the PHQ-9 will be measured at baseline before treatment, each week during the treatment, and again at 10 weeks post-treatment. The range of possible scores on the PHQ-9 is 0 to 27 and higher scores indicate worse outcome or more severe depression

2. Weekly Kessler Psychological Distress Scale (K-10) Score [Week 10 score]

   The K-10 is a 10-item self-report measure of psychological distress. Items are scored on a scale from 1" ("none of the time") to "5" ("all of the time"). Total K-10 scores range from 10 to 50, with higher scores reflecting worse outcome or higher distress.

3. Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID) [baseline, 10 weeks]

   At 10 weeks (post-treatment), we will look for improvement from baseline in key brain regions known to be affected by depression. Differences in EIT and MID task-related brain responses will be measured.

4. Change From Baseline in Positive and Negative Affect Scale (PANAS) Score [Baseline visit and 10 weeks after baseline visit]

   Participants' scores on the PANAS will be measured at baseline before treatment, and again at 10 weeks post-treatment. Two scores can be derived. 1) A positive affect score can range from 10 to 50, with higher scores representing better outcome or higher levels of positive affect; 2) Negative Affect score can range from 10 to 50, with higher scores representing better outcome or lower levels of negative affect.

5. Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score [Baseline visit, and 10 weeks after baseline visit]

   Participants' scores on the CD-RISC will be measured at baseline before treatment, and again at 10 weeks post-treatment. Total scores range from 0 to 100, with higher scores indicating a better outcome or higher resilience

6. Change From Baseline in Modified Erikson Flanker Test [Baseline visit and 10 weeks after baseline visit.]

   Participants' scores on the Modified Erikson Flanker Test will be measured at baseline before treatment, and again at 10 weeks post-treatment. Accuracy scores range from 0 to 1 with higher scores reflecting better outcome.

7. Change From Baseline in Implicit Association Test (IAT) [Baseline visit, 10 weeks after baseline visit.]

   Participants' scores on the IAT will be measured at baseline before treatment, and again at 10 weeks post-treatment. The IAT effect is called the D score with a possible range of -2 to +2, with larger scores reflecting worse outcome and stronger suicidality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Age range between 18 and 45.

• Subjects must be right handed (as measured by Edinburgh Handedness Inventory).

• The primary language of the subjects must be English

• Must have regular access to a computer with internet connection and printer (for potential MDD or MAC participants)

• DSM-IV criteria for current Major Depressive Episode according to SCID (for enrollment into MDD or MAC groups)

• Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants)

• PHQ-9 score below 5 (for enrollment into HC group)

Exclusion criteria:

• Any history of neurological illness or brain injury

• Current or past DSM-IV Axis I disorder (for enrollment into HC group)

• Complicating medical conditions that may influence the outcome of neuropsychological assessment or functional imaging (e.g., HIV)

• Mixed or left-handedness

• Abnormal visual acuity that is not corrected by contact lenses

• Metal within the body, claustrophobia, or other contraindications for MRI

• Less than 9th grade education

• Past or current alcohol/substance dependence, or current alcohol abuse, or current or past substance abuse (i.e. past alcohol abuse is not exclusionary)

• Use of illicit drugs within the past year

• Use of marijuana within the past month

• Current use of opioid or prescribed stimulant medications

• History of a psychotic mental illness (schizophrenia or bipolar disorder)

• Current severe symptoms of depression (total score > 23 or responding > 1 to Question 9 for suicidal ideation in the Patient Health Questionnaire-9 Item [PHQ-9] (Kroenke et al., 2001))

• A PHQ-9 score below 10 (for potential MDD or MAC participants)

• Currently participating in Cognitive Behavior Therapy

• History of ECT treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Isabelle Rosso	Belmont	Massachusetts	United States	02478

Sponsors and Collaborators

• Mclean Hospital

Investigators

• Principal Investigator: Scott L Rauch, MD, Mclean Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
• Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22.
• Titov N, Andrews G, Davies M, McIntyre K, Robinson E, Solley K. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance. PLoS One. 2010 Jun 8;5(6):e10939. doi: 10.1371/journal.pone.0010939.

• Responsible Party: Scott Rauch, President and Psychiatrist-in-Chief, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT01598922
• Other Study ID Numbers: W81XWH-12-1-0109
• First Posted: May 15, 2012
• Last Update Posted: May 25, 2021
• Last Verified: May 1, 2021

• Keywords provided by Scott Rauch, President and Psychiatrist-in-Chief, Mclean Hospital: Depression; Internet Cognitive Behavioral Therapy; fMRI; Neuroimaging
• Additional relevant MeSH terms: Depressive Disorder; Depressive Disorder, Major

Study Results

Participant Flow

Pre-assignment Detail	Healthy control subjects were not part of the clinical trial (they were not assigned to treatment).

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Period Title: Overall Study
STARTED	37	40
COMPLETED	34	30
NOT COMPLETED	3	10

Baseline Characteristics

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control	Total
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study	Total of all reporting groups
Overall Participants	37	40	77
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.2 (7.7)	28.8 (6.7)	29.0 (7.2)
Sex: Female, Male (Count of Participants)
Female	23 62.2%	30 75%	53 68.8%
Male	14 37.8%	10 25%	24 31.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	6 16.2%	5 12.5%	11 14.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 2.7%	2 5%	3 3.9%
White	23 62.2%	25 62.5%	48 62.3%
More than one race	1 2.7%	3 7.5%	4 5.2%
Unknown or Not Reported	6 16.2%	5 12.5%	11 14.3%
Marital status, married (Count of Participants)
Count of Participants [Participants]	5 13.5%	8 20%	13 16.9%
Education (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	15.4 (2.5)	15.3 (2.0)	15.4 (2.3)
Employed outside the home (Count of Participants)
Count of Participants [Participants]	28 75.7%	24 60%	52 67.5%
Hamilton Rating Scale for Depression, 17 items (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	15.7 (4.0)	15.7 (4.3)	15.7 (4.2)
Patient Health Questionnaire, 9 items (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.9 (3.9)	15.6 (4.0)	14.8 (4.0)
Kessler Distress, 10 items (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	28.9 (5.4)	30.8 (4.5)	29.9 (5.0)

Outcome Measures

1. Primary Outcome

Title	Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17).
Description	To assess change in severity of depression symptoms. The total score is reported, which is the sum of the ratings of all items and ranges from 0 to 52, with higher scores indicating a worse outcome or greater severity of depression symptoms.
Time Frame	Measured at the baseline visit and 10 weeks after the baseline visit

Outcome Measure Data

Analysis Population Description

Note that these are sample sizes.

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Measure Participants	37	40
Pre-treatment HRSD-17	15.73 (4.02)	15.70 (4.26)
Post-treatment HRSD-17	9.17 (6.92)	14.05 (5.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Internet Cognitive Behavioral Therapy, Monitored Attention Control
	Comments
	Type of Statistical Test	Other
	Comments	Intent-to-treat (ITT) analyses following multiple imputation. Generalized Linear Models (GENLIN) predicting post-treatment HRSD scores in the imputed dataset. Covarying for pre-treatment HRSD scores, age and sex.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	GENLIN
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.11
	Confidence Interval	(2-Sided) 95%; 2.814 to 9.403
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.68
	Estimation Comments

2. Secondary Outcome

Title	Weekly Patient Health Questionnaire (PHQ-9) Score
Description	Participants' scores on the PHQ-9 will be measured at baseline before treatment, each week during the treatment, and again at 10 weeks post-treatment. The range of possible scores on the PHQ-9 is 0 to 27 and higher scores indicate worse outcome or more severe depression
Time Frame	Baseline visit, and 10 weeks after baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Measure Participants	37	40
Mean (Standard Deviation) [score on a scale]	9.17 (6.92)	14.05 (5.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Internet Cognitive Behavioral Therapy, Monitored Attention Control
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.024
	Comments	Hierarchical Linear Modeling (HLM) was applied to PHQ-9 data, adjusting for baseline PHQ-9 score. Group x Time interactions tested for between-group differences in slope of improvement of PHQ-9 scores.
	Method	hierarchical linear modeling
	Comments	Age and sex were covariates. Cohen's d effect sizes are reported.
Method of Estimation	Estimation Parameter	Cohen's d measure of effect size
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 95%; -1.25 to -0.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Weekly Kessler Psychological Distress Scale (K-10) Score
Description	The K-10 is a 10-item self-report measure of psychological distress. Items are scored on a scale from 1" ("none of the time") to "5" ("all of the time"). Total K-10 scores range from 10 to 50, with higher scores reflecting worse outcome or higher distress.
Time Frame	Week 10 score

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Measure Participants	37	40
Mean (Standard Deviation) [units on a scale]	20.14 (7.37)	26.73 (6.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Internet Cognitive Behavioral Therapy, Monitored Attention Control
	Comments	The Kessler Psychological Distress Scale (K-10) is a 10-item scale with total scores that can range from 0 to 50. Higher scores represent worse (more severe) psychological distress.
	Type of Statistical Test	Other
	Comments	Hierarchical Linear Modeling (HLM) was applied to K-10 data, adjusting for baseline K-10 score. Group x Time interactions tested for between-group differences in slope of improvement of K-10 scores.
Statistical Test of Hypothesis	p-Value	.003
	Comments
	Method	HLM
	Comments
Method of Estimation	Estimation Parameter	Cohen's d measure of effect size
	Estimated Value	-0.95
	Confidence Interval	(2-Sided) 95%; -1.42 to -0.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID)
Description	At 10 weeks (post-treatment), we will look for improvement from baseline in key brain regions known to be affected by depression. Differences in EIT and MID task-related brain responses will be measured.
Time Frame	baseline, 10 weeks

Outcome Measure Data

Analysis Population Description

Analysis still ongoing, anticipated until January 2022

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Measure Participants	0	0

5. Secondary Outcome

Title	Change From Baseline in Positive and Negative Affect Scale (PANAS) Score
Description	Participants' scores on the PANAS will be measured at baseline before treatment, and again at 10 weeks post-treatment. Two scores can be derived. 1) A positive affect score can range from 10 to 50, with higher scores representing better outcome or higher levels of positive affect; 2) Negative Affect score can range from 10 to 50, with higher scores representing better outcome or lower levels of negative affect.
Time Frame	Baseline visit and 10 weeks after baseline visit

Outcome Measure Data

Analysis Population Description

Data not analyzed due to funding ending for this study

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Measure Participants	0	0

6. Secondary Outcome

Title	Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score
Description	Participants' scores on the CD-RISC will be measured at baseline before treatment, and again at 10 weeks post-treatment. Total scores range from 0 to 100, with higher scores indicating a better outcome or higher resilience
Time Frame	Baseline visit, and 10 weeks after baseline visit

Outcome Measure Data

Analysis Population Description

Data not analyzed due to funding ending for this study.

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Measure Participants	0	0

7. Secondary Outcome

Title	Change From Baseline in Modified Erikson Flanker Test
Description	Participants' scores on the Modified Erikson Flanker Test will be measured at baseline before treatment, and again at 10 weeks post-treatment. Accuracy scores range from 0 to 1 with higher scores reflecting better outcome.
Time Frame	Baseline visit and 10 weeks after baseline visit.

Outcome Measure Data

Analysis Population Description

Data still being analyzed and not analysis/paper not anticipated to be completed until January 2022

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Measure Participants	0	0

8. Secondary Outcome

Title	Change From Baseline in Implicit Association Test (IAT)
Description	Participants' scores on the IAT will be measured at baseline before treatment, and again at 10 weeks post-treatment. The IAT effect is called the D score with a possible range of -2 to +2, with larger scores reflecting worse outcome and stronger suicidality
Time Frame	Baseline visit, 10 weeks after baseline visit.

Outcome Measure Data

Analysis Population Description

Data not analyzed due to funding ending.

Arm/Group Title	Internet Cognitive Behavioral Therapy	Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Measure Participants	0	0

Adverse Events

Time Frame	10 weeks
Arm/Group Title	Internet Cognitive Behavioral Therapy		Monitored Attention Control
Arm/Group Description	Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.		Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
All Cause Mortality
	Internet Cognitive Behavioral Therapy		Monitored Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Internet Cognitive Behavioral Therapy		Monitored Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Internet Cognitive Behavioral Therapy		Monitored Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.