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

NCT01770990 | Completed

• 1 other identifier: 01KQ1002B-TP7-Tel-PT
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline, approximately 3 months (end of treatment)

Secondary Outcomes (3)

• Patient-rated acceptance of intervention

  Approximately 3 months (end of treatment)

• Need for further, more intensive treatment for depression (therapist-rated)

  Approximately 3 months (end of treatment)

• Premature dropout from treatment

  Approximately 3 months (end of treatment)

Study Arms (2)

Tel-PT without mail

ACTIVE COMPARATOR

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

Behavioral: Tel-PT without mail

Tel-PT including mail

EXPERIMENTAL

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

Interventions

Tel-PT including mail BEHAVIORAL

Patients receive telephone-based psychotherapy and one letter after each telephone session.

Tel-PT including mail

Tel-PT without mail BEHAVIORAL

Patients receive telephone-based psychotherapy without additional letters.

Tel-PT without mail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of mild or moderate depression
• sufficient knowledge of German language
• health situation that allows questionnaire completion

You may not qualify if:

• insufficient knowledge of German language
• health condition not allowing questionnaire completion

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

NFKBIZ protein, human

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Birgit Watzke, Prof. Dr.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 18, 2013
• Study Start: September 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 14, 2015

Record last verified: 2015-07

Locations

DE (1)