Trial of Telephone-based Psychotherapy for Depression With and Without Adjunctive Supportive Mail
NCT ID: NCT01770990
Last Updated: 2015-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
59 participants
INTERVENTIONAL
2012-09-30
2015-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Telephone-administered Relapse Prevention for Depression
NCT03219879
Effectiveness and Cost-effectiveness of Telephone-delivered Psychotherapy for Depression in Primary Care
NCT02667366
Development of a Telephone-based Continuation Treatment for Patients With Chronic Depression.
NCT02397850
Randomized-controlled Trial of Aftercare-Coordination by Phone for Depression and Anxiety
NCT02044913
A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
NCT04996433
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tel-PT without mail
Telephone-based psychotherapy (1 personal session, 8-10 telephone sessions, educational materials and monitoring questionnaires) without additional motivating letters.
Tel-PT without mail
Patients receive telephone-based psychotherapy without additional letters.
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.
Tel-PT including mail
Patients receive telephone-based psychotherapy and one letter after each telephone session.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tel-PT including mail
Patients receive telephone-based psychotherapy and one letter after each telephone session.
Tel-PT without mail
Patients receive telephone-based psychotherapy without additional letters.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* sufficient knowledge of German language
* health situation that allows questionnaire completion
Exclusion Criteria
* health condition not allowing questionnaire completion
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Birgit Watzke, Prof. Dr.
Role: STUDY_DIRECTOR
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf , Hamburg, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf
Hamburg, City state of Hamburg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
01KQ1002B-TP7-Tel-PT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.