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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Tel-PT
* Behavioral: TAU and text messages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tel-PT<br>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. | Behavioral: Tel-PT<br> <br> |
| Active Comparator: TAU and text messages<br>Control Group receives treatment as usual and additionally weekly text messages containing general information about depression. | Behavioral: TAU and text messages<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | 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 | 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 | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild and moderate depression