Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

11 oktober 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

56

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Zurich, Zwitserland, 8050
        • University of Zurich

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: TAU and text messages
Control Group receives treatment as usual and additionally weekly text messages containing general information about depression.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in depressive symptoms
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in depressive symptoms
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Acceptance and satisfaction with the intervention
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: t1 (four months after baseline), t2 (12 months after baseline)
Dropout rate
t1 (four months after baseline), t2 (12 months after baseline)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2016

Primaire voltooiing (Verwacht)

1 maart 2019

Studie voltooiing (Verwacht)

1 maart 2019

Studieregistratiedata

Eerst ingediend

3 december 2015

Eerst ingediend dat voldeed aan de QC-criteria

27 januari 2016

Eerst geplaatst (Schatting)

28 januari 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 oktober 2018

Laatste update ingediend die voldeed aan QC-criteria

11 oktober 2018

Laatst geverifieerd

1 oktober 2018

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • BW-0417

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Tel-PT

Abonneren