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Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

3. marts 2020 opdateret af: Olof Johansson, Lund University
Depression treatments including physical activity and sleep management has been shown to relieve depressive symptoms among participants suffering depressive episodes. This study evaluates the potential of these methods as prevention of depressive relapse or recurrence

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Sverige
    • Skåne
      • Malmö, Skåne, Sverige, 21431
        • Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö

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

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • A history of at least one episode of Major Depression.
  • If medicating - Taking a stable (since one month) and therapeutic dosage of antidepressant medication
  • Being able to read and write Swedish
  • Having access to the internet

Exclusion Criteria:

  • Fulfilling the criteria for Major depression
  • Bipolar disorder
  • Psychosis
  • Substance abuse
  • Suicidality
  • Currently in psychotherapy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Therapist-assisted iCBT
Internet-delivered cognitive behavioral therapy (iCBT), containing physical activity and sleep management for preventing depressive relapse. Monthly depression screening with therapist feedback.
Adfærdsmæssigt: Therapist-assisted iCBT
13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
Adfærdsmæssigt: Monthly screening with feedback
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
Aktiv komparator: Monthly screening with feedback
Monthly depression screening with therapist feedback.
Adfærdsmæssigt: Monthly screening with feedback
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
Ingen indgriben: Control
No intervention, follow-up along with all participants at 6 and 12-months.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depressive relapse (change in diagnostic status, SCID-I)
Tidsramme: Baseline - 12 months
Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV
Baseline - 12 months
Change from baseline in depressive symptoms (MADRS-S)
Tidsramme: Baseline - 6 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Baseline - 6 months
Change from baseline in depressive symptoms (MADRS-S)
Tidsramme: Baseline - 12 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Baseline - 12 months
Change from baseline in depressive symptoms (MADRS-S)
Tidsramme: Monthly, 0-12 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Monthly, 0-12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in health related quality of life (EQ-5D)
Tidsramme: Baseline - 3 months
Health related quality of life will be measured by an internet based version of the EQ-5D.
Baseline - 3 months
Change from baseline in health related quality of life (EQ-5D)
Tidsramme: Baseline - 6 months
Health related quality of life will be measured by an internet based version of the EQ-5D.
Baseline - 6 months
Change from baseline in health related quality of life (EQ-5D)
Tidsramme: Baseline - 9 months
Health related quality of life will be measured by an internet based version of the EQ-5D.
Baseline - 9 months
Change from baseline in health related quality of life (EQ-5D)
Tidsramme: Baseline - 12 months
Health related quality of life will be measured by an internet based version of the EQ-5D.
Baseline - 12 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Tidsramme: Baseline - 3 months
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.
Baseline - 3 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Tidsramme: Baseline - 6 months
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.
Baseline - 6 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Tidsramme: Baseline - 9 months
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.
Baseline - 9 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Tidsramme: Baseline - 12 months
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.
Baseline - 12 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Tidsramme: Baseline - 3 months
The International Physical Activity Questionnaire is a measure of physical activity
Baseline - 3 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Tidsramme: Baseline - 6 months
The International Physical Activity Questionnaire is a measure of physical activity
Baseline - 6 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Tidsramme: Baseline - 9 months
The International Physical Activity Questionnaire is a measure of physical activity
Baseline - 9 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Tidsramme: Baseline - 12 months
The International Physical Activity Questionnaire is a measure of physical activity
Baseline - 12 months
Morisky Medication Adherence Scale (MMAS-8)
Tidsramme: Baseline - 3 months
Self-reported measure of medication adherence
Baseline - 3 months
Morisky Medication Adherence Scale (MMAS-8)
Tidsramme: Baseline - 6 months
Self-reported measure of medication adherence
Baseline - 6 months
Morisky Medication Adherence Scale (MMAS-8)
Tidsramme: Baseline - 9 months
Self-reported measure of medication adherence
Baseline - 9 months
Morisky Medication Adherence Scale (MMAS-8)
Tidsramme: Baseline - 12 months
Self-reported measure of medication adherence
Baseline - 12 months
Insomnia Severity Index (ISI)
Tidsramme: Baseline - 3 months
Insomnia issues
Baseline - 3 months
Insomnia Severity Index (ISI)
Tidsramme: Baseline - 6 months
Insomnia issues
Baseline - 6 months
Insomnia Severity Index (ISI)
Tidsramme: Baseline - 9 months
Insomnia issues
Baseline - 9 months
Insomnia Severity Index (ISI)
Tidsramme: Baseline - 12 months
Insomnia issues
Baseline - 12 months
Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: Baseline - 3 months
Baseline - 3 months
Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: Baseline - 6 months
Baseline - 6 months
Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: Baseline - 9 months
Baseline - 9 months
Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: Baseline - 12 months
Baseline - 12 months
Time to depressive relapse
Tidsramme: Baseline - 12 months
Time to depressive relapse is recorded as secondary outcome variable
Baseline - 12 months
Self reported treatment seeking
Tidsramme: Baseline - 12 months
Treatment seeking among participants is recorded as secondary outcome variable
Baseline - 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Lund University

Efterforskere

  • Ledende efterforsker: Lars-Gunnar Lundh, Professor, Lund University, Departement of psychology

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. februar 2016

Primær færdiggørelse (Faktiske)

1. december 2019

Studieafslutning (Faktiske)

1. december 2019

Datoer for studieregistrering

Først indsendt

5. november 2015

Først indsendt, der opfyldte QC-kriterier

5. november 2015

Først opslået (Skøn)

6. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • rel-prev

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Kliniske forsøg med Depression

Kliniske forsøg med Therapist-assisted iCBT

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