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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Internet Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet Cognitive Behavioral Therapy<br>Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program. | Behavioral: Internet Cognitive Behavioral Therapy<br>* 8 weeks of online treatment program<br>|
| No Intervention: Monitored Attention Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Internet Cognitive Behavioral Therapy, fMRI, Neuroimaging