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Computerized Cognitive Behavioral Therapy and Electroconvulsive Therapy

5. Januar 2017 aktualisiert von: Yale University

Evaluating the Feasibility and Efficacy of Computerized Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Electroconvulsive Therapy

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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Connecticut
      • New Haven, Connecticut, Vereinigte Staaten, 06519
        • Yale University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Verhalten: 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/.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Beck Depression Inventory
Zeitfenster: Baseline

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
Zeitfenster: week 2

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
Zeitfenster: 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.
Week 5 through week 15

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Yale University

Ermittler

  • Hauptermittler: Samule Wilkonson, MD, Yale School of Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2014

Primärer Abschluss (Tatsächlich)

1. August 2015

Studienabschluss (Tatsächlich)

1. Dezember 2016

Studienanmeldedaten

Zuerst eingereicht

25. Juni 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2014

Zuerst gepostet (Schätzen)

27. Juni 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

9. Januar 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Januar 2017

Zuletzt verifiziert

1. Januar 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1404013837

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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