Trial of Telephone-based Psychotherapy for Depression With and Without Adjunctive Supportive Mail (Tel-PT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01770990
First received: January 8, 2013
Last updated: June 25, 2013
Last verified: June 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Prof. 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: June 25, 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 September 14, 2014