Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

11 oktober 2018 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

56

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studieorter

      • Zurich, Schweiz, 8050
        • University of Zurich

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

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in depressive symptoms
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in depressive symptoms
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acceptance and satisfaction with the intervention
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: t1 (four months after baseline), t2 (12 months after baseline)
Dropout rate
t1 (four months after baseline), t2 (12 months after baseline)

Samarbetspartners och utredare

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

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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 januari 2016

Primärt slutförande (Förväntat)

1 mars 2019

Avslutad studie (Förväntat)

1 mars 2019

Studieregistreringsdatum

Först inskickad

3 december 2015

Först inskickad som uppfyllde QC-kriterierna

27 januari 2016

Första postat (Uppskatta)

28 januari 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 oktober 2018

Senast verifierad

1 oktober 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • BW-0417

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Depression

Kliniska prövningar på Tel-PT

Prenumerera