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Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems (TAYLOR1)

27. december 2010 opdateret af: Linkoeping University

Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems

The overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Internet-delivered cognitive behaviour therapy (CBT) has emerged as a promising way to administer evidence-based psychological treatments. Mild to moderate major depression has previously been found to treatable via the Internet, with the provision that minimal therapist guidance is given. However, previous research has not taken the issue of comorbidity into account. It is well known that major depression often is accompanied by anxiety and in addition the symptom profile in major depression may differ substantially. The idea behind the proposed research is to tailor the Internet intervention according to the symptom profile. By used a large set of treatment modules (text-based) we aim to diagnose and then prescribe modules. In a randomized trial we want to compare this procedure (e.g., tailored CBT) with the standard Internet-delivered CBT. We will also include a control group in the form of a supervised online discussion group who will later receive CBT.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

121

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Sverige
      • Linköping, Sverige
        • Linköping University, Department of Behavioral Sciences and Learning

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of Major Depressive Disorder
  • 15 or more on MADRS-S

Exclusion Criteria:

  • Severe depression (more than 35 on MADRS-S or based on interview)
  • Severe psychiatric condition (e.g. psychosis or bipolar disorder)
  • Changed medication during the last three months

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tailored Internet-delivered CBT
Adfærdsmæssigt: Tailored Internet-delivered CBT
This intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
Eksperimentel: Non-tailored Internet-delivered CBT
Adfærdsmæssigt: Non-tailored Internet-delivered CBT
Specific text-based self-help for depression, which has previously been tested in three previous randomized trials. Anxiety symptoms will not be covered, but insomnia is included as a module together with advice on health.
Aktiv komparator: Online discussion group
Adfærdsmæssigt: Online discussion group
Participants take part of an online discussion group which are monitored daily. New discussion topics on depression are introduced every week.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Beck Depression Inventory (BDI)
Tidsramme: Ved behandlingsophør (10 uger)
Ved behandlingsophør (10 uger)
Beck Depression Inventory (BDI)
Tidsramme: One week before the treatment starts
One week before the treatment starts
Beck Depression Inventory (BDI)
Tidsramme: Five weeks after treatment started
Five weeks after treatment started
Beck Depression Inventory (BDI)
Tidsramme: 6 month after treatment ended
6 month after treatment ended
Beck Depression Inventory (BDI)
Tidsramme: 2 years after treatment ended
2 years after treatment ended

Sekundære resultatmål

Resultatmål
Tidsramme
Beck Anxiety Inventory (BAI)
Tidsramme: Ved behandlingsophør (10 uger)
Ved behandlingsophør (10 uger)
Montgomery Åsberg Depression Rating Scale Self-rapport (MADRS-S)
Tidsramme: Ved behandlingsophør (10 uger)
Ved behandlingsophør (10 uger)
Livskvalitetsinventar (QOLI)
Tidsramme: Ved behandlingsophør (10 uger)
Ved behandlingsophør (10 uger)
Beck Anxiety Inventory (BAI)
Tidsramme: One week before the treatment starts
One week before the treatment starts
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Tidsramme: One week before the treatment starts
One week before the treatment starts
Quality of Life Inventory (QOLI)
Tidsramme: One week before the treatment starts
One week before the treatment starts
Beck Anxiety Inventory (BAI)
Tidsramme: Five weeks after treatment started
Five weeks after treatment started
Beck Anxiety Inventory (BAI)
Tidsramme: 6 month after treatment ended
6 month after treatment ended
Beck Anxiety Inventory (BAI)
Tidsramme: 2 years after treatment ended
2 years after treatment ended
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Tidsramme: Five weeks after treatment started
Five weeks after treatment started
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Tidsramme: 6 month after treatment ended
6 month after treatment ended
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Tidsramme: 2 years after treatment ended
2 years after treatment ended
Quality of Life Inventory (QOLI)
Tidsramme: Five weeks after treatment started
Five weeks after treatment started
Quality of Life Inventory (QOLI)
Tidsramme: 6 month after treatment ended
6 month after treatment ended
Quality of Life Inventory (QOLI)
Tidsramme: 2 years after treatment ended
2 years after treatment ended

Samarbejdspartnere og efterforskere

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

Sponsor

Linkoeping University

Efterforskere

  • Ledende efterforsker: Gerhard Andersson, PhD, Department of Behavioral Sciences and Learning, Linköping University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.

Datoer for studieregistrering

Først indsendt

9. august 2010

Først indsendt, der opfyldte QC-kriterier

12. august 2010

Først opslået (Skøn)

13. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. december 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. december 2010

Sidst verificeret

1. december 2010

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GA-VR-DEP2009-1

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 Tailored Internet-delivered CBT

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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