search
Back to results

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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Tel-PT including mail
Tel-PT without mail
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, telephone-based psychotherapy, cognitive-behavioral psychotherapy, manualized psychotherapy, telephone counseling, telephone psychological treatment, telephone-administered therapy, low-intensity treatment, motivational mail, reminder, letter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tel-PT without mail

Tel-PT including mail

Arm Description

Telephone-based psychotherapy (1 personal session, 8-10 telephone sessions, educational materials and monitoring questionnaires) without additional motivating letters.

Telephone-based psychotherapy (1 personal session, 8-10 telephone sessions, educational materials and monitoring questionnaires) with an additional motivating letter after every telephone session.

Outcomes

Primary Outcome Measures

Change in depression symptom severity (PHQ-D-9)
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
Patients rate their acceptance of the intervention using non-standardized items.
Need for further, more intensive treatment for depression (therapist-rated)
The treating psychotherapist rates the necessity of stepping the patient up to a further, more intensive treatment for depression.
Premature dropout from treatment
The rate at which patients drop out from treatment prematurely.

Full Information

First Posted
January 8, 2013
Last Updated
July 13, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
search

1. Study Identification

Unique Protocol Identification Number
NCT01770990
Brief Title
Trial of Telephone-based Psychotherapy for Depression With and Without Adjunctive Supportive Mail
Acronym
Tel-PT
Official Title
Randomized Trial of Telephone-Based Psychotherapy for Depression With and Without Adjunctive Supportive Mail
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, telephone-based psychotherapy, cognitive-behavioral psychotherapy, manualized psychotherapy, telephone counseling, telephone psychological treatment, telephone-administered therapy, low-intensity treatment, motivational mail, reminder, letter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tel-PT without mail
Arm Type
Active Comparator
Arm Description
Telephone-based psychotherapy (1 personal session, 8-10 telephone sessions, educational materials and monitoring questionnaires) without additional motivating letters.
Arm Title
Tel-PT including mail
Arm Type
Experimental
Arm Description
Telephone-based psychotherapy (1 personal session, 8-10 telephone sessions, educational materials and monitoring questionnaires) with an additional motivating letter after every telephone session.
Intervention Type
Behavioral
Intervention Name(s)
Tel-PT including mail
Intervention Description
Patients receive telephone-based psychotherapy and one letter after each telephone session.
Intervention Type
Behavioral
Intervention Name(s)
Tel-PT without mail
Intervention Description
Patients receive telephone-based psychotherapy without additional letters.
Primary Outcome Measure Information:
Title
Change in depression symptom severity (PHQ-D-9)
Description
Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel & Herzog, 2002)
Time Frame
Baseline, approximately 3 months (end of treatment)
Secondary Outcome Measure Information:
Title
Patient-rated acceptance of intervention
Description
Patients rate their acceptance of the intervention using non-standardized items.
Time Frame
Approximately 3 months (end of treatment)
Title
Need for further, more intensive treatment for depression (therapist-rated)
Description
The treating psychotherapist rates the necessity of stepping the patient up to a further, more intensive treatment for depression.
Time Frame
Approximately 3 months (end of treatment)
Title
Premature dropout from treatment
Description
The rate at which patients drop out from treatment prematurely.
Time Frame
Approximately 3 months (end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Watzke, Prof. Dr.
Organizational Affiliation
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf , Hamburg, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs