- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02397850
Development of a Telephone-based Continuation Treatment for Patients With Chronic Depression.
Optimizing Psychotherapeutic Aftercare for Patients Suffering From Chronic/Recurrent Depression: Development and First Evaluation of a Telephone-based Continuation Treatment (Pilot Study).
There is a high risk for relapse in people suffering from depression. Studies indicate that the continuation of an acute psychotherapeutic treatment can reduce the likelihood of relapse. Therefore, this pilot study is aimed to investigate the feasibility of a continuation psychotherapy over 6 months, to support people suffering from chronic forms of depression in their daily life. The investigated continuation therapy itself includes about one telephone call per month (therapist - patient), focussing on the integration of strategies into the patient's daily routine. The patients receive either 30 minutes or 50 minutes phone calls. On the one hand, these phone calls are supported by a workbook for patients containing psychoeducative elements, strategies and exercises. On the other hand, the therapist's work is based on a manual containing several modules and strategies. Both tools (workbook, manual) are understood as a framework, using the appropriate sections according to the patient's needs. As a result, the patients receive a continuation treatment which is appropriate and adapted to their individual situation.
The main purpose of this pilot study is to evaluate the feasibility of a telephone based psychotherapeutic continuation treatment with a small sample of 20 patients suffering from chronic depression. In case of promising results the effectiveness of this kind of treatment is going to be investigated within a comparative trial (including face-to-face intervention, no intervention).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Zurich, Switzerland, 8091
- UniversitätsSpital Zürich Klinik für Psychiatrie und Psychotherapie Ambulatorium
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent
- Diagnosis of chronic (300.4) or recurrent (296.31-3) depression (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- Currently in partial or full remission
- Previous psychotherapy (acute treatment; some kind of cognitive-behavioral therapy)
- adequate knowledge of German language
- in case of taking antidepressants: long-term and stable dosage (with unchanged taking since 3 months at least)
Exclusion Criteria:
- acute suicidality
- psychotic symptoms
- severe cognitive impairments
- in case of taking antidepressants: anticipated stopping medication within treatment period (6 months)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 30 min or 50 min
Patients receive either seven 30 minutes or 50 minutes phone calls over 6 months (psychotherapy/continuation treatment)
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Patients receive either seven 30 minutes phone calls over 6 months (psychotherapy/continuation treatment)
Patients receive either seven 50 minutes phone calls over 6 months (psychotherapy/continuation treatment)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of patients dropping out of treatment
Time Frame: 6 months
|
6 months
|
|
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change of depressive symptoms from baseline to posttreatment
Time Frame: 6 months
|
assessed by the Patient Health Questionnaire
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Birgit Watzke, Prof. Dr., University of Zurich
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WATZKE-892
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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