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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet Cognitive Behavioral Therapy | Experimental | Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program. |
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| Monitored Attention Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet Cognitive Behavioral Therapy | Behavioral | 8 weeks of online treatment program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). | 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. | Measured at the baseline visit and 10 weeks after the baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Patient Health Questionnaire (PHQ-9) Score | 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 | Baseline visit, and 10 weeks after baseline visit |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott L Rauch, MD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isabelle Rosso | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20183695 | Background | 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. | |
| 15229303 | Background | 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. doi: 10.1056/NEJMoa040603. |
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Healthy control subjects were not part of the clinical trial (they were not assigned to treatment).
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| ID | Title | Description |
|---|---|---|
| FG000 | Internet Cognitive Behavioral Therapy | 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. |
| FG001 | Monitored Attention Control | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Internet Cognitive Behavioral Therapy | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). | 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. | Note that these are sample sizes. | Posted | Mean | Standard Deviation | score on a scale | Measured at the baseline visit and 10 weeks after the baseline visit |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Internet Cognitive Behavioral Therapy | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Isabelle Rosso | McLean Hospital | 6178552607 | irosso@partners.org |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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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.
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| Weekly Kessler Psychological Distress Scale (K-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. | Week 10 score |
| Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID) | 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. | baseline, 10 weeks |
| Change From Baseline in Positive and Negative Affect Scale (PANAS) Score | 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. | Baseline visit and 10 weeks after baseline visit |
| Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score | 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 | Baseline visit, and 10 weeks after baseline visit |
| Change From Baseline in Modified Erikson Flanker Test | 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. | Baseline visit and 10 weeks after baseline visit. |
| Change From Baseline in Implicit Association Test (IAT) | 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 | Baseline visit, 10 weeks after baseline visit. |
| 20544030 | Background | 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. |
| 28009467 | Result | Rosso IM, Killgore WD, Olson EA, Webb CA, Fukunaga R, Auerbach RP, Gogel H, Buchholz JL, Rauch SL. Internet-based cognitive behavior therapy for major depressive disorder: A randomized controlled trial. Depress Anxiety. 2017 Mar;34(3):236-245. doi: 10.1002/da.22590. Epub 2016 Dec 23. |
| 29486867 | Derived | Webb CA, Olson EA, Killgore WDS, Pizzagalli DA, Rauch SL, Rosso IM. Rostral Anterior Cingulate Cortex Morphology Predicts Treatment Response to Internet-Based Cognitive Behavioral Therapy for Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Mar;3(3):255-262. doi: 10.1016/j.bpsc.2017.08.005. Epub 2017 Aug 26. |
| Monitored Attention Control |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Marital status, married | Count of Participants | Participants |
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| Education | Mean | Standard Deviation | Years |
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| Employed outside the home | Count of Participants | Participants |
|
| Hamilton Rating Scale for Depression, 17 items | The Hamilton Rating Scale for Depression, 17 item (HRSD-17) was the primary outcome measure of depression severity, administered by doctoral-level raters at pre-treatment/baseline and post-treatment. Each item is rated on a 3- or 5- point scale (0-2 or 0-4), and total HRSD scores can range from 0 to 52. There are 17 items (questions) in this scale, each scored on a 3-point or 5-point scale. Higher scores indicate more severe (worse) symptoms. Total scores vary from 0 to 52. Total scores are represented in this report. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire, 9 items | The Patient Health Questionnaire-9 (PHQ-9) is a well-validated self-report measure of depression severity. The scale presents each of the nine DSM-IV MDD symptoms to be rated on a 4-point frequency scale ranging from "0" (not at all) to "3" (nearly every day). Higher scores indicate more severe (worse) symptoms. Total scores vary from 0 to 27. Total scores are represented in this report. | Mean | Standard Deviation | units on a scale |
|
| Kessler Distress, 10 items | The Kessler Psychological Distress Scale (K10) is a 10-item self-report measure that yields a score of distress based on questions about anxiety and depressive symptoms that the person has experience in the prior 4 week period. The K10 comprises 10 questions that are answered using a five-point scale (where 5 = all of the time, and 1 = none of the time). The total range of scores is 10 to 50. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Monitored Attention Control | 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 |
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| Secondary | Weekly Patient Health Questionnaire (PHQ-9) Score | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline visit, and 10 weeks after baseline visit |
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| Secondary | Weekly Kessler Psychological Distress Scale (K-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. | Posted | Mean | Standard Deviation | units on a scale | Week 10 score |
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| Secondary | Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID) | 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. | Analysis still ongoing, anticipated until January 2022 | Posted | baseline, 10 weeks |
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| Secondary | Change From Baseline in Positive and Negative Affect Scale (PANAS) Score | 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. | Data not analyzed due to funding ending for this study | Posted | Baseline visit and 10 weeks after baseline visit |
|
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| Secondary | Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score | 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 | Data not analyzed due to funding ending for this study. | Posted | Baseline visit, and 10 weeks after baseline visit |
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| Secondary | Change From Baseline in Modified Erikson Flanker Test | 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. | Data still being analyzed and not analysis/paper not anticipated to be completed until January 2022 | Posted | Baseline visit and 10 weeks after baseline visit. |
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| Secondary | Change From Baseline in Implicit Association Test (IAT) | 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 | Data not analyzed due to funding ending. | Posted | Baseline visit, 10 weeks after baseline visit. |
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| 0 |
| 37 |
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| 37 |
| EG001 | Monitored Attention Control | 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 | 0 | 40 | 0 | 40 |
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| D001519 |
| Behavior |