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

11 octobre 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

56

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Zurich, Suisse, 8050
        • University of Zurich

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comparateur actif: TAU and text messages
Control Group receives treatment as usual and additionally weekly text messages containing general information about depression.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in depressive symptoms
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in depressive symptoms
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Acceptance and satisfaction with the intervention
Délai: 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
Délai: 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
Délai: 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
Délai: t1 (four months after baseline), t2 (12 months after baseline)
Dropout rate
t1 (four months after baseline), t2 (12 months after baseline)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2016

Achèvement primaire (Anticipé)

1 mars 2019

Achèvement de l'étude (Anticipé)

1 mars 2019

Dates d'inscription aux études

Première soumission

3 décembre 2015

Première soumission répondant aux critères de contrôle qualité

27 janvier 2016

Première publication (Estimation)

28 janvier 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 octobre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 octobre 2018

Dernière vérification

1 octobre 2018

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • BW-0417

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Tel-PT

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