Skip to main content
Clinical Trials/NCT01598922
NCT01598922
Completed
Not Applicable

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

Mclean Hospital1 site in 1 country77 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Mclean Hospital
Enrollment
77
Locations
1
Primary Endpoint
Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17).
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
August 2015
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Scott Rauch

President and Psychiatrist-in-Chief

Mclean Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17).

Time Frame: 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 Outcomes

  • Weekly Patient Health Questionnaire (PHQ-9) Score(Baseline visit, and 10 weeks after baseline visit)
  • Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID)(baseline, 10 weeks)
  • Change From Baseline in Implicit Association Test (IAT)(Baseline visit, 10 weeks after baseline visit.)
  • Weekly Kessler Psychological Distress Scale (K-10) Score(Week 10 score)
  • Change From Baseline in Positive and Negative Affect Scale (PANAS) Score(Baseline visit and 10 weeks after baseline visit)
  • Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score(Baseline visit, and 10 weeks after baseline visit)
  • Change From Baseline in Modified Erikson Flanker Test(Baseline visit and 10 weeks after baseline visit.)

Study Sites (1)

Loading locations...

Similar Trials