Computerized Cognitive Behavioral Therapy and Electroconvulsive Therapy

NCT02176473 | Completed

• 1 other identifier: 1404013837
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Depression

Outcome Measures

Primary Outcomes (3)

• Beck Depression Inventory

  The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression . The treatment group will undergo depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. Depression rating scales will include the BDI, QIDS-SR, MADRS, CGI, and MOCA. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR.

  Baseline

• Beck Depression Inventory

  The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression . The treatment group will undergo depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. Depression rating scales will include the BDI, QIDS-SR, MADRS, CGI, and MOCA. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR.

  week 2

• Beck Depression Inventory

  The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression . The treatment group will undergo depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. Depression rating scales will include the BDI, QIDS-SR, MADRS, CGI, and MOCA. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR.

  Week 5 through week 15

Secondary Outcomes (4)

• Quick Inventory of Depressive Symptomology (QIDS)

  Baseline, Week 2, week 5, week 10, week 15

• Montgomery-Åsberg Depression Rating Scale ( MADRS)

  Baseline, Week 2, week 5, week 10, week 15

• Clinical Global Impression (CGI)

  Baseline, Week 2, week 5, week 10, week 15

• Montreal Cognitive Assessment (MoCA)

  Baseline, Week 2, week 5, week 10, week 15

Study Arms (1)

Computerized Cognitive Behavioral Therapy

EXPERIMENTAL

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).

Behavioral: Computerized Cognitive Behavioral Therapy

Interventions

Computerized Cognitive Behavioral Therapy 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/.

Computerized Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• meet DSM-5 criteria for depressive episodes
• able to use a computer

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Samule Wilkonson, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2016
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

US (1)