Computerized Cognitive Behavioral Therapy and Electroconvulsive Therapy

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Computerized Cognitive Behavioral Therapy

• Registration Number: NCT02176473
• Lead Sponsor: Yale University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Primary Completion: 2015-08
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 18-75 years old
• meet DSM-5 criteria for depressive episodes
• able to use a computer

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computerized Cognitive Behavioral Therapy	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).

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory	Week 5 through week 15	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.

Secondary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomology (QIDS)	Baseline, Week 2, week 5, week 10, week 15	The16 item Quick Inventory of Depressive Symptomatology (QIDS) (an abbreviated version of the 30 item Inventory of Depressive Symptomatology (IDS) is designed to assess the severity of depressive symptoms.; The treatment group will undergo the same 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. 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.
Montgomery-Åsberg Depression Rating Scale ( MADRS)	Baseline, Week 2, week 5, week 10, week 15	The Montgomery-Åsberg Depression Rating Scale ( MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.; The treatment group will undergo the same 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. 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.
Clinical Global Impression (CGI)	Baseline, Week 2, week 5, week 10, week 15	The Clinical Global Impression rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.; The treatment group will undergo the same 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. 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.
Montreal Cognitive Assessment (MoCA)	Baseline, Week 2, week 5, week 10, week 15	The Montreal Cognitive Assessment (MoCA) measures mild cognitive impairment.; The treatment group will undergo the same 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. 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.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States