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

Not Applicable

Completed

Conditions: Major Depressive Disorder

Interventions: Behavioral: Internet Cognitive Behavioral Therapy

Registration Number: NCT01598922

Lead Sponsor: Mclean Hospital

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet Cognitive Behavioral Therapy	Internet Cognitive Behavioral Therapy	Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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
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.
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.
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
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.