Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle
3. mars 2020 oppdatert 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
150
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Skåne
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Malmö, Skåne, Sverige, 21431
- Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
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Aktiv komparator: Monthly screening with feedback
Monthly depression screening with therapist feedback.
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Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
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Ingen inngripen: Control
No intervention, follow-up along with all participants at 6 and 12-months.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Depressive relapse (change in diagnostic status, SCID-I)
Tidsramme: Baseline - 12 months
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Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV
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Baseline - 12 months
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Change from baseline in depressive symptoms (MADRS-S)
Tidsramme: Baseline - 6 months
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Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
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Baseline - 6 months
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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.
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Baseline - 12 months
|
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Change from baseline in depressive symptoms (MADRS-S)
Tidsramme: Monthly, 0-12 months
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Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
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Monthly, 0-12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in health related quality of life (EQ-5D)
Tidsramme: Baseline - 3 months
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Health related quality of life will be measured by an internet based version of the EQ-5D.
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Baseline - 3 months
|
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Change from baseline in health related quality of life (EQ-5D)
Tidsramme: Baseline - 6 months
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Health related quality of life will be measured by an internet based version of the EQ-5D.
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Baseline - 6 months
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Change from baseline in health related quality of life (EQ-5D)
Tidsramme: Baseline - 9 months
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Health related quality of life will be measured by an internet based version of the EQ-5D.
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Baseline - 9 months
|
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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.
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Baseline - 12 months
|
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Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Tidsramme: Baseline - 3 months
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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.
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Baseline - 3 months
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Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Tidsramme: Baseline - 6 months
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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
|
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Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Tidsramme: Baseline - 3 months
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The International Physical Activity Questionnaire is a measure of physical activity
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Baseline - 3 months
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Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Tidsramme: Baseline - 6 months
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The International Physical Activity Questionnaire is a measure of physical activity
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Baseline - 6 months
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Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Tidsramme: Baseline - 9 months
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The International Physical Activity Questionnaire is a measure of physical activity
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Baseline - 9 months
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Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Tidsramme: Baseline - 12 months
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The International Physical Activity Questionnaire is a measure of physical activity
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Baseline - 12 months
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Morisky Medication Adherence Scale (MMAS-8)
Tidsramme: Baseline - 3 months
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Self-reported measure of medication adherence
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Baseline - 3 months
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Morisky Medication Adherence Scale (MMAS-8)
Tidsramme: Baseline - 6 months
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Self-reported measure of medication adherence
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Baseline - 6 months
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Morisky Medication Adherence Scale (MMAS-8)
Tidsramme: Baseline - 9 months
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Self-reported measure of medication adherence
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Baseline - 9 months
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Morisky Medication Adherence Scale (MMAS-8)
Tidsramme: Baseline - 12 months
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Self-reported measure of medication adherence
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Baseline - 12 months
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Insomnia Severity Index (ISI)
Tidsramme: Baseline - 3 months
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Insomnia issues
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Baseline - 3 months
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Insomnia Severity Index (ISI)
Tidsramme: Baseline - 6 months
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Insomnia issues
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Baseline - 6 months
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Insomnia Severity Index (ISI)
Tidsramme: Baseline - 9 months
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Insomnia issues
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Baseline - 9 months
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Insomnia Severity Index (ISI)
Tidsramme: Baseline - 12 months
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Insomnia issues
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Baseline - 12 months
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Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: Baseline - 3 months
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Baseline - 3 months
|
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Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: Baseline - 6 months
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Baseline - 6 months
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Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: Baseline - 9 months
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Baseline - 9 months
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Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: Baseline - 12 months
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Baseline - 12 months
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Time to depressive relapse
Tidsramme: Baseline - 12 months
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Time to depressive relapse is recorded as secondary outcome variable
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Baseline - 12 months
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Self reported treatment seeking
Tidsramme: Baseline - 12 months
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Treatment seeking among participants is recorded as secondary outcome variable
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Baseline - 12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Lars-Gunnar Lundh, Professor, Lund University, Departement of psychology
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2016
Primær fullføring (Faktiske)
1. desember 2019
Studiet fullført (Faktiske)
1. desember 2019
Datoer for studieregistrering
Først innsendt
5. november 2015
Først innsendt som oppfylte QC-kriteriene
5. november 2015
Først lagt ut (Anslag)
6. november 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
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