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Effectiveness and Cost-effectiveness of Telephone-delivered Psychotherapy for Depression in Primary Care

11. oktober 2018 opdateret af: University of Zurich

Improving Access to Evidence-based Treatment for Depression: Effectiveness and Cost-effectiveness of Telephone-delivered Cognitive Behavioral Therapy (CBT) in Primary Care

The aim of the study is the examination of effectiveness and cost-effectiveness of a telephone-based psychotherapy (Tel-PT) for depression compared to treatment as usual in primary care.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

The overall purpose of the study is to examine the effectiveness of telephone psychotherapy (Tel-PT) for the treatment of mild to moderate depression on different outcome-levels and under clinically representative conditions in Swiss primary health care. The randomized-controlled trial (RCT) will evaluate the primary hypothesis that Tel-PT is more effective than routine primary care (i.e. treatment as usual, TAU), more specifically, that it leads to significant higher reduction in depression severity than TAU at follow-up.

The intervention group (IG) receives a manualized short-term cognitive behavioral treatment, which is the adapted German version of the program "Creating a balance" developed in the USA. The therapy consists of one face-to-face and 8-12 telephone contacts and is carried out by a licensed psychotherapist.

More concrete, recruitment and inclusion of the patients will be carried out by the participating general practitioners (GPs). GPs will be instructed to screen patients at risk for depression, especially those revealing diffuse somatic symptoms and suffering from chronic diseases. If positively screened, patient's depressive symptoms are assessed with Patient Health Questionnaire (PHQ-9) and diagnosed according to ICD-10.

All GPs will receive an initial training prior to their participation, providing them with study information and procedures as well as training in screening procedure, psychodiagnostics and study enrolment.

Eligible patients are provided with detailed study information and asked to participate. Subsequently, patients will give informed consent. Patients will then be included into the study and fill out the baseline questionnaires (t0). After that, randomization will be carried out at the University of Zurich, based on an appropriately created computer algorithm. Both GPs and patients are informed about the results by the study team within two days. Subsequently, patients in control group (CG) will receive regular text messages and patients in the intervention group (IG) will be called by the study therapist to schedule an initial appointment.

In case of positive results, the overarching objective is the optimization of mental health services for depressed patients by implementing an evidence-based, accessible and cost-effective treatment option into primary care.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

56

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Zurich, Schweiz, 8050
        • University of Zurich

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:

  • PHQ-9 score of > 5 and ≤15.
  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Minimum age of 18 years
  • Diagnosis of mild to moderate depression according to ICD-10 (F32.0, F32.1, F33.0, F33.1)

Exclusion Criteria:

  • Patients currently being in psychotherapeutic treatment or treatment in past three months
  • Suicidal tendencies or suicidality
  • Insufficient knowledge of German language
  • Health condition that does not allow questionnaire completion

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: Tel-PT
Tel-PT receives a manualized short-term CBT. Treatment consists of one initial face-to-face appointment and 8-12 subsequent telephone sessions between patient and licensed therapist. Each telephone contact lasts between 20 and 30 minutes and take place on a weekly and later biweekly basis.
Aktiv komparator: TAU and text messages
Control Group receives treatment as usual and additionally weekly text messages containing general information about depression.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in depressive symptoms
Tidsramme: t0 (baseline) and t2 (12 months after baseline)
The change in depressive symptoms will be assessed with the German version of Patient Health Questionnaire (PHQ-9; Löwe, Spitzer, Zipfel, & Herzog 2002).
t0 (baseline) and t2 (12 months after baseline)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in depressive symptoms
Tidsramme: t0 (baseline) and t1 (four months after baseline)
The change in depressive symptoms will be assessed with the German version of Patient Health Questionnaire (PHQ-9; Löwe, Spitzer, Zipfel, & Herzog 2002).
t0 (baseline) and t1 (four months after baseline)
Response
Tidsramme: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Response defined as 50% reduction in the PHQ-9.
t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Change in health-related quality of life
Tidsramme: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Change in health-related quality of life is measured with the 12-Item Short Form Health Survey (SF-12; Bullinger & Kirchberger, 1998).
t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Self-efficacy for management and relapse prevention in depression
Tidsramme: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Depression self-efficacy scale for management and relapse prevention (Bush et al., 2001).
t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Cost-effectiveness
Tidsramme: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Health care utilization and productivity loss will be measured with an adapted version of the Client Sociodemographic and Service Receipt Inventory (CSSRI; Chisholm et al., 2000). For Switzerland, country-specific unit costs will be employed to calculate direct and indirect costs.
t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Cost-effectiveness
Tidsramme: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Health-related quality of life for the economic analyses will be measured using the EQ-5D-5L (The EuroQuol Group, 1990), Quality-adjusted life years (QALYs) based on the EQ-5D index will be determined and the incremental cost-effectiveness ratio (ICER) will be computed.
t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptance and satisfaction with the intervention
Tidsramme: t1 (four months after baseline)
Patients' and therapists' acceptance and satisfaction with the intervention will be assessed by a self-constructed questionnaire.
t1 (four months after baseline)
Process and structural variable
Tidsramme: t1 (four months after baseline), t2 (12 months after baseline)
Mean duration of telephone contacts
t1 (four months after baseline), t2 (12 months after baseline)
Process and structural variable
Tidsramme: t1 (four months after baseline), t2 (12 months after baseline)
Mean number of telephone contacts.
t1 (four months after baseline), t2 (12 months after baseline)
Process and structural variable
Tidsramme: t1 (four months after baseline), t2 (12 months after baseline)
Dropout rate
t1 (four months after baseline), t2 (12 months after baseline)

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Birgit Watzke, Prof, University of Zurich, Department of Clinical Psychology and Psychotherapy Research

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.

Studer store datoer

Studiestart

1. januar 2016

Primær færdiggørelse (Forventet)

1. marts 2019

Studieafslutning (Forventet)

1. marts 2019

Datoer for studieregistrering

Først indsendt

3. december 2015

Først indsendt, der opfyldte QC-kriterier

27. januar 2016

Først opslået (Skøn)

28. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • BW-0417

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 Tel-PT

3
Abonner