- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01449890
Randomized Trial of Depression Follow-up Care by Email
3. juni 2015 opdateret af: PD Dr. phil. Birgit Watzke, Universitätsklinikum Hamburg-Eppendorf
Randomized Trial of E-mail Follow-up Care After Cognitive Behavioural Treatment for Depression
The primary objective of this study is to test in a randomized effectiveness trial if e-mail delivered cognitive behavioural treatment is an effective follow-up care approach in the treatment of depression under clinically representative conditions.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Depression belongs to the most prevalent mental disorders and often goes along with a high burden of disease.
Although the efficacy and the effectiveness of psychological treatments for depressive disorders have been demonstrated, there remains the problem of maintaining the benefits achieved during the initial treatment phase.
Therefore options of follow-up care have to be considered.
Since access to psychotherapeutic treatments is limited and costly, internet-based interventions can offer a feasible opportunity for follow-up care in order to enhance the long-term effectiveness of psychotherapy.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
92
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hamburg, Tyskland, 20246
- University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology
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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
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Depressive disorder: F32.0-F32.2; F33.0-F33.2; F34.1 according to ICD-10
- Precursory CBT
- Internet access
Exclusion Criteria:
- No knowledge of the German language
- Risk of suicide
- Acute psychosis or psychotic symptoms
- Established concurrent in vivo CBT after discharge from inpatient 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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: E-mail follow up care
After having terminated inpatient CBT patients receive follow up care by email for 12 weeks (on average one contact per week).
The follow up care aims at supporting the patients in continuing exercises they have learned during the initial treatment phase in order to cope with depression, e.g.
integrating positive activities in their all day life or monitoring the interdependence of cognition, emotion and behaviour.
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After having terminated inpatient CBT patients receive follow up care by email for 12 weeks (on average one contact per week).
The follow up care aims at supporting the patients in continuing exercises in order to cope with depression.
Andre navne:
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Ingen indgriben: Treatment as usual
After having terminated inpatient CBT patients receive treatment as usual within routine care.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Measure of the severity of depression - Beck Depression Inventory (BDI- II)
Tidsramme: Change in the BDI-II from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
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Change in the BDI-II from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Measure of health related quality of life - SF-8
Tidsramme: Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care
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SF-8: short version of the SF -36
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Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care
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GAD-7
Tidsramme: Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
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Measure for generalized anxiety disorder
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Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
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Depressive relapse/recurrence
Tidsramme: Measured at follow up (3 months after termination of the follow-up care)
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Measured at follow up (3 months after termination of the follow-up care)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Birgit Watzke, PhD, University Medical Center Hamburg-Eppendorf Centre of Psychosocial Medicine Department of Medical 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. september 2012
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
6. oktober 2011
Først indsendt, der opfyldte QC-kriterier
7. oktober 2011
Først opslået (Skøn)
10. oktober 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DRV0422/00-40-65-50-24
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 .
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Sheba Medical CenterIkke rekrutterer endnu
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Polytechnic Institute of PortoHospital de Sao Joao, PortoIkke rekrutterer endnuBehandlingsresistent depression | Depression - svær depressiv lidelse
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Second Affiliated Hospital of Tsinghua UniversityIkke rekrutterer endnu
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