NCT02397850

Brief Summary

There is a high risk for relapse in people suffering from depression. Studies indicate that the continuation of an acute psychotherapeutic treatment can reduce the likelihood of relapse. Therefore, this pilot study is aimed to investigate the feasibility of a continuation psychotherapy over 6 months, to support people suffering from chronic forms of depression in their daily life. The investigated continuation therapy itself includes about one telephone call per month (therapist - patient), focussing on the integration of strategies into the patient's daily routine. The patients receive either 30 minutes or 50 minutes phone calls. On the one hand, these phone calls are supported by a workbook for patients containing psychoeducative elements, strategies and exercises. On the other hand, the therapist's work is based on a manual containing several modules and strategies. Both tools (workbook, manual) are understood as a framework, using the appropriate sections according to the patient's needs. As a result, the patients receive a continuation treatment which is appropriate and adapted to their individual situation. The main purpose of this pilot study is to evaluate the feasibility of a telephone based psychotherapeutic continuation treatment with a small sample of 20 patients suffering from chronic depression. In case of promising results the effectiveness of this kind of treatment is going to be investigated within a comparative trial (including face-to-face intervention, no intervention).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

January 14, 2015

Last Update Submit

November 6, 2017

Conditions

Keywords

depression, chronic, psychotherapy, telephone, feasibility

Outcome Measures

Primary Outcomes (2)

  • number of patients dropping out of treatment

    6 months

  • change of depressive symptoms from baseline to posttreatment

    assessed by the Patient Health Questionnaire

    6 months

Study Arms (1)

30 min or 50 min

EXPERIMENTAL

Patients receive either seven 30 minutes or 50 minutes phone calls over 6 months (psychotherapy/continuation treatment)

Behavioral: phone calls 30 minBehavioral: phone calls 50 min

Interventions

Patients receive either seven 30 minutes phone calls over 6 months (psychotherapy/continuation treatment)

30 min or 50 min

Patients receive either seven 50 minutes phone calls over 6 months (psychotherapy/continuation treatment)

30 min or 50 min

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Diagnosis of chronic (300.4) or recurrent (296.31-3) depression (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
  • Currently in partial or full remission
  • Previous psychotherapy (acute treatment; some kind of cognitive-behavioral therapy)
  • adequate knowledge of German language
  • in case of taking antidepressants: long-term and stable dosage (with unchanged taking since 3 months at least)

You may not qualify if:

  • acute suicidality
  • psychotic symptoms
  • severe cognitive impairments
  • in case of taking antidepressants: anticipated stopping medication within treatment period (6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversitätsSpital Zürich Klinik für Psychiatrie und Psychotherapie Ambulatorium

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

DepressionBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Birgit Watzke, Prof. Dr.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

March 25, 2015

Study Start

February 1, 2015

Primary Completion

May 20, 2017

Study Completion

October 25, 2017

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations