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

Not Applicable

• Conditions: Depression
• Interventions: Behavioral: TAU and text messages; Behavioral: Tel-PT

• Registration Number: NCT02667366
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-12-03
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-28
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU and text messages	TAU and text messages	Control Group receives treatment as usual and additionally weekly text messages containing general information about depression.
Tel-PT	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.

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms	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).

Secondary Outcome Measures

Name	Time	Method
Change in depressive symptoms	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).
Response	t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)	Response defined as 50% reduction in the PHQ-9.
Change in health-related quality of life	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).
Self-efficacy for management and relapse prevention in depression	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).
Cost-effectiveness	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.

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland