Short-term Caregiver Psychotherapy

October 25, 2016 updated by: Ingo Kilimann, University of Rostock

Psychotherapeutical Short-term Intervention for Caregivers of Persons With Dementia

This study is to test the feasibility (pilot part) and efficacy (phase IIa part) of a specifically on the needs of caregivers of people with dementia composed new short-term psychotherapeutical intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective study will be offered to caregivers from the out patient clinic of the Department of Psychosomatic Medicine of the University Rostock Medical Center. In a first pilot study with 10 participants without control group, we tested the feasability and acceptance of the program (completed 2/2015). From 4/2015 a phase IIa study started with 10 participants in the intervention group and 10 in the control groups (will be organized by waiting list). The program consists of two modules of caregiver education followed by ten psychotherapeutic group modules. Duration of each module is planned to be 90 minutes including a relaxation exercise at the end of each module. Primary outcomes are the feasibility, acceptance and the effect on caregiver burden.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • MV
      • Rostock, MV, Germany, 18147
        • University of Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • caregiver of a person with dementia
  • willing to participate in all 12 modules of the program

Exclusion Criteria:

  • current psychotherapy or antidepressive medication for less than 6 month
  • major depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventiongroup
Psychotherapy
Behavioral: Psychotherapy
The program is designed for 10 participants and consists of two modules of caregiver education followed by ten psychotherapeutic group modules. The major overarching topics will be (i) caregiver´s emotional and physical limits, (ii) conscious and unconscious feelings and emotions towards the people with dementia and (iii) activation of caregivers´ social resources. Duration of each module is planned to be 90 minutes including a relaxation exercise at the end of each module.
No Intervention: Waitling list group
waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in perceived self-efficacy directly and 3 month after psychotherapeutical intervention and reduction of symptoms of depression
Time Frame: before intervention, 0 and 3 month after end of intervention
SWE, a german self-efficacy self-rating scale, will be used for self-efficacy measurement AND ADS (German Version of the CES-D Scale) for measurement for symptoms of depression
before intervention, 0 and 3 month after end of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of perceived burden of care
Time Frame: before intervention, 0 and 3 month after end of intervention
We will be using the Zarit-Burden-Interview to measure the perceived burden of care
before intervention, 0 and 3 month after end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Collaborators

German Center for Neurodegenerative Diseases (DZNE)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RO020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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