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

July 13, 2015 updated by: Universitätsklinikum Hamburg-Eppendorf

Randomized Trial of Telephone-Based Psychotherapy for Depression With and Without Adjunctive Supportive Mail

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to compare the effectiveness of two telephone-based psychotherapy (Tel-PT) interventions for patients with mild to moderate depression. 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).

In both conditions, patients are referred to telephone-based psychotherapy by their general physician within the framework of the larger study. Both intervention programs are based on the translated and adapted German version of a depression-specific program developed by researchers in Seattle. Both include psycho-educational materials (patient workbook and therapist manual) and comprise 1 personal session, 8 to 10 telephone contacts (20 to 40 minutes) carried out weekly and in some cases bi-weekly, as well as up to 2 maintenance therapy telephone sessions for patients responding well to telephone-based psychotherapy (see monitoring process below). Both programs have a duration of approximately 3 months and follow a cognitive-behavioral approach with main focus on behavioral activation and cognitive restructuring and are carried out by licensed cognitive-behavioral psychotherapists receiving weekly to bi-weekly supervision.

In both conditions, depressive symptoms are monitored with the Patient Health Questionnaire depression module (PHQ-9) at the personal session at baseline and the fourth and eighth telephone sessions. Additionally, psychotherapists complete non-standardized assessments regarding general progress and therapeutic alliance after each session. Decisions about further treatment are to be supported by monitoring results: If symptoms are reduced by at least 20% from baseline to the fourth telephone session, the following sessions are to be stretched to a bi-weekly frequency; if not, continued weekly sessions are recommended. If the PHQ-9-score lies under the cut-off point of 5 by the eighth session, patients are to continue with maintenance therapy. If the PHQ-9-score remains above the cut-off point, transfer into a higher-intensity treatment is recommended. For those patients receiving maintenance therapy, a further monitoring at the end of maintenance therapy is performed and patients above the PHQ-9 cut-off score are also recommended to transfer to a higher-intensity treatment. In case of acute suicidality, emergency measures are carried out: e.g. additional psychiatric treatment in an in- or outpatient setting. Psychotherapists contact the patients' general physicians at begin and end of treatment, as well as on other occasions if necessary. Psychotherapists facilitate transferrals to other mental health care specialists within the stepped care project if necessary.

Patients in the study condition "Tel-PT including mail" receive a one-page letter from their psychotherapist after every telephone session. The letter contains motivational messages as well as a summary of the homework planned during the session and a reminder of the appointment made for the next session. The letters will usually be received by patients approximately two to three days after the telephone session and are meant to refresh memory of and motivation for the planned assignments.

Patients in the study condition "Tel-PT without mail" receive no letters from their psychotherapist.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression symptom severity (PHQ-D-9)
Time Frame: Baseline, approximately 3 months (end of treatment)
Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel & Herzog, 2002)
Baseline, approximately 3 months (end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-rated acceptance of intervention
Time Frame: Approximately 3 months (end of treatment)
Patients rate their acceptance of the intervention using non-standardized items.
Approximately 3 months (end of treatment)
Need for further, more intensive treatment for depression (therapist-rated)
Time Frame: Approximately 3 months (end of treatment)
The treating psychotherapist rates the necessity of stepping the patient up to a further, more intensive treatment for depression.
Approximately 3 months (end of treatment)
Premature dropout from treatment
Time Frame: Approximately 3 months (end of treatment)
The rate at which patients drop out from treatment prematurely.
Approximately 3 months (end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01KQ1002B-TP7-Tel-PT

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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