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Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

3 mars 2020 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

150

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: Therapist-assisted iCBT
13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
Beteende: 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.
Beteende: Monthly screening with feedback
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
Inget ingripande: Control
No intervention, follow-up along with all participants at 6 and 12-months.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Depressive relapse (change in diagnostic status, SCID-I)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in health related quality of life (EQ-5D)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline - 12 months
The International Physical Activity Questionnaire is a measure of physical activity
Baseline - 12 months
Morisky Medication Adherence Scale (MMAS-8)
Tidsram: Baseline - 3 months
Self-reported measure of medication adherence
Baseline - 3 months
Morisky Medication Adherence Scale (MMAS-8)
Tidsram: Baseline - 6 months
Self-reported measure of medication adherence
Baseline - 6 months
Morisky Medication Adherence Scale (MMAS-8)
Tidsram: Baseline - 9 months
Self-reported measure of medication adherence
Baseline - 9 months
Morisky Medication Adherence Scale (MMAS-8)
Tidsram: Baseline - 12 months
Self-reported measure of medication adherence
Baseline - 12 months
Insomnia Severity Index (ISI)
Tidsram: Baseline - 3 months
Insomnia issues
Baseline - 3 months
Insomnia Severity Index (ISI)
Tidsram: Baseline - 6 months
Insomnia issues
Baseline - 6 months
Insomnia Severity Index (ISI)
Tidsram: Baseline - 9 months
Insomnia issues
Baseline - 9 months
Insomnia Severity Index (ISI)
Tidsram: Baseline - 12 months
Insomnia issues
Baseline - 12 months
Alcohol Use Disorder Identification Test (AUDIT)
Tidsram: Baseline - 3 months
Baseline - 3 months
Alcohol Use Disorder Identification Test (AUDIT)
Tidsram: Baseline - 6 months
Baseline - 6 months
Alcohol Use Disorder Identification Test (AUDIT)
Tidsram: Baseline - 9 months
Baseline - 9 months
Alcohol Use Disorder Identification Test (AUDIT)
Tidsram: Baseline - 12 months
Baseline - 12 months
Time to depressive relapse
Tidsram: Baseline - 12 months
Time to depressive relapse is recorded as secondary outcome variable
Baseline - 12 months
Self reported treatment seeking
Tidsram: Baseline - 12 months
Treatment seeking among participants is recorded as secondary outcome variable
Baseline - 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Lund University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2016

Primärt slutförande (Faktisk)

1 december 2019

Avslutad studie (Faktisk)

1 december 2019

Studieregistreringsdatum

Först inskickad

5 november 2015

Först inskickad som uppfyllde QC-kriterierna

5 november 2015

Första postat (Uppskatta)

6 november 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 mars 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 mars 2020

Senast verifierad

1 mars 2020

Mer information

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