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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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/. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depressive Symptomology (QIDS) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samule Wilkonson, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06519 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Baseline, Week 2, week 5, week 10, week 15 |
| Montgomery-Åsberg Depression Rating Scale ( MADRS) | 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. | Baseline, Week 2, week 5, week 10, week 15 |
| Clinical Global Impression (CGI) | 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. | Baseline, Week 2, week 5, week 10, week 15 |
| Montreal Cognitive Assessment (MoCA) | 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. | Baseline, Week 2, week 5, week 10, week 15 |