Computerized Cognitive Behavioral Therapy and Electroconvulsive Therapy

NCT ID: NCT02176473

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-12-31

Brief Summary

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).

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Computerized Cognitive Behavioral Therapy

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).

Group Type: EXPERIMENTAL

Computerized Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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/.

Interventions

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/.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samule Wilkonson, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1404013837

Identifier Type: -

Identifier Source: org_study_id