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Computerized Cognitive Behavioral Therapy and Electroconvulsive Therapy

5. januar 2017 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06519
        • Yale University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Adfærdsmæssigt: 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/.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Beck Depression Inventory
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quick Inventory of Depressive Symptomology (QIDS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yale University

Efterforskere

  • Ledende efterforsker: Samule Wilkonson, MD, Yale School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2014

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

25. juni 2014

Først indsendt, der opfyldte QC-kriterier

26. juni 2014

Først opslået (Skøn)

27. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1404013837

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med Computerized Cognitive Behavioral Therapy

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