This trial is active, not recruiting.

Condition depression
Treatment computerized cognitive behavioral therapy
Sponsor Yale University
Start date June 2014
End date August 2015
Trial size 30 participants
Trial identifier NCT02176473, 1404013837


In an open-label feasibility study, fifteen will be recruited to participate in the study from among those who have already chosen of their own accord to undergo ECT (standard of care) at Yale Psychiatric Hospital for treatment of a depressive episode. These patients will receive computer-assisted cognitive behavior therapy (CCBT).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
A computerized version of CBT has been developed in an effort to more widely disseminate the powerful effects of this psychotherapy modality, with studies showing efficacy comparable to that of traditional CBT.8 The present study aims to further investigate the feasibility of combining ECT and computerized CBT (c-CBT).
computerized cognitive behavioral therapy
The c-CBT software focuses on the same principles of traditional CBT, namely, "identifying, labeling, and modifying automatic thoughts; the link between thought and action; identifying and modifying schemas; and identifying and correcting cognitive errors."9 C-CBT is delivered in 9 online lessons, each designed to take 30-45 minutes to complete. The software provides modeling of CBT principles (in the form of short videos), enables an interactive forum by giving users feedback based on responses to questions, and encourages participants to employ the skills learned in CBT to their situations. A 9-minute video demonstrating the functionality of Good Days Ahead can be found at: http://www.empower-interactive.com/solutions/good-days-ahead/.

Primary Outcomes

Beck Depression Inventory
time frame: Baseline
Beck Depression Inventory
time frame: week 2
Beck Depression Inventory
time frame: Week 5 through week 15

Secondary Outcomes

Quick Inventory of Depressive Symptomology (QIDS)
time frame: Baseline, Week 2, week 5, week 10, week 15
Montgomery-Åsberg Depression Rating Scale ( MADRS)
time frame: Baseline, Week 2, week 5, week 10, week 15
Clinical Global Impression (CGI)
time frame: Baseline, Week 2, week 5, week 10, week 15
Montreal Cognitive Assessment (MoCA)
time frame: Baseline, Week 2, week 5, week 10, week 15

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - 18-75 years old - meet DSM-5 criteria for depressive episodes - able to use a computer Exclusion Criteria: - diagnosis of an axis II (personality disorder) - active suicidal thoughts with a plan - current substance use disorder - non-affective psychosis - prior treatment with ECT in the past 6 months - CBT treatment in the past 12 months - dementia - delirium or another other neurological or mental disease that might affect cognition or the ability to meaningfully participate in computerized CBT

Additional Information

Official title Evaluating the Feasibility and Efficacy of Computerized Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Electroconvulsive Therapy
Principal investigator Samule Wilkonson, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Yale University.