Development of a Telephone-based Continuation Treatment f... | NCT02397850

Studies
Development of a Telephone-based Continuation Treatment for Patients With Chronic Depression.

NCT02397850

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Nov 7, 2017Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Chronic Depressive Disorder

Interventions

phone calls 30 min
phone calls 50 min

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

May 20, 2017Actual

Completion Date

Oct 25, 2017Actual

First Submitted Date

Jan 14, 2015

First Submission Date that Met QC Criteria

Mar 19, 2015

First Posted Date

Mar 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2017

Last Update Posted Date

Nov 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 min Behavioral: phone calls 50 min

Interventions

Name	Type	Description	Arm Group Labels	Other Names
phone calls 30 min	Behavioral	Patients receive either seven 30 minutes phone calls over 6 months (psychotherapy/continuation treatment)	30 min or 50 min

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Birgit Watzke, Prof. Dr.	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UniversitätsSpital Zürich Klinik für Psychiatrie und Psychotherapie Ambulatorium		Zurich		8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans

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