Trial of Telephone-based Psychotherapy for Depression With and Without Adjunctive Supportive Mail (Tel-PT)
This study is currently recruiting participants.
Verified January 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01770990
First received: January 8, 2013
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
This study aims to compare the effectiveness of two telephone-based psychotherapy (Tel-PT) interventions for patients with mild to moderate depression. Both interventions consist of one personal session and weekly to bi-weekly 8-10 telephone sessions with a licensed cognitive-behavioral psychotherapist accompanied by the study of educational materials and the completion of regular monitoring questionnaires (total treatment duration: approximately 3 months). Patients are randomized into one of two conditions: Patients in the condition "Tel-PT including mail" additionally receive a motivating letter from their psychotherapist after each telephone session, while patients in the condition "Tel-PT without mail" receive no further interventions. Patients refusing to be randomized are to be assigned to the condition "Tel-PT without mail". This study takes place within a larger study evaluating a stepped care model for depression (01KQ1002B-TP7).
| Condition | Intervention |
|---|---|
|
Depression |
Behavioral: Tel-PT including mail Behavioral: Tel-PT without mail |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Telephone-Based Psychotherapy for Depression With and Without Adjunctive Supportive Mail |
Resource links provided by NLM:
Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:
Primary Outcome Measures:
- Change in depression symptom severity (PHQ-D-9) [ Time Frame: Baseline, approximately 3 months (end of treatment) ] [ Designated as safety issue: No ]Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel & Herzog, 2002)
Secondary Outcome Measures:
- Patient-rated acceptance of intervention [ Time Frame: Approximately 3 months (end of treatment) ] [ Designated as safety issue: No ]Patients rate their acceptance of the intervention using non-standardized items.
- Need for further, more intensive treatment for depression (therapist-rated) [ Time Frame: Approximately 3 months (end of treatment) ] [ Designated as safety issue: No ]The treating psychotherapist rates the necessity of stepping the patient up to a further, more intensive treatment for depression.
- Premature dropout from treatment [ Time Frame: Approximately 3 months (end of treatment) ] [ Designated as safety issue: No ]The rate at which patients drop out from treatment prematurely.
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Tel-PT without mail
Telephone-based psychotherapy (1 personal session, 8-10 telephone sessions, educational materials and monitoring questionnaires) without additional motivating letters.
|
Behavioral: Tel-PT without mail
Patients receive telephone-based psychotherapy without additional letters.
|
|
Experimental: Tel-PT including mail
Telephone-based psychotherapy (1 personal session, 8-10 telephone sessions, educational materials and monitoring questionnaires) with an additional motivating letter after every telephone session.
|
Behavioral: Tel-PT including mail
Patients receive telephone-based psychotherapy and one letter after each telephone session.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- diagnosis of mild or moderate depression
- sufficient knowledge of German language
- health situation that allows questionnaire completion
Exclusion Criteria:
- insufficient knowledge of German language
- health condition not allowing questionnaire completion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770990
Contacts
| Contact: Maya Steinmann, Dipl.-Psych. | +49 (040) 7410 57558 | m.steinmann@uke.de |
| Contact: Daniela Heddaeus, Dipl.-Psych. | +49 (040) 7410 57558 | d.heddaeus@uke.de |
Locations
| Germany | |
| Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Maya Steinmann, Dipl.-Psych. +49 (040) 7410 57558 m.steinmann@uke.de | |
| Contact: Daniela Heddaeus, Dipl.-Psych. +49 (040) 7410 57558 d.heddaeus@uke.de | |
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
| Study Director: | Birgit Watzke, PD Dr. | Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf , Hamburg, Germany |
More Information
No publications provided
| Responsible Party: | Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT01770990 History of Changes |
| Other Study ID Numbers: | 01KQ1002B-TP7-Tel-PT |
| Study First Received: | January 8, 2013 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
|
depression telephone-based psychotherapy cognitive-behavioral psychotherapy manualized psychotherapy telephone counseling telephone psychological treatment |
telephone-administered therapy low-intensity treatment motivational mail reminder letter |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013