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Clinical Trials/NCT02175953
NCT02175953
Completed
Phase 2

Psychotherapeutical Short-term Intervention for Caregivers of Persons With Dementia

University of Rostock1 site in 1 country13 target enrollmentJune 2014

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Caregiver Burden of People With Dementia
Sponsor
University of Rostock
Enrollment
13
Locations
1
Primary Endpoint
Change in perceived self-efficacy directly and 3 month after psychotherapeutical intervention and reduction of symptoms of depression
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Rostock
Responsible Party
Principal Investigator
Principal Investigator

Ingo Kilimann

Neurologist

University of Rostock

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • reduction of perceived burden of care(before intervention, 0 and 3 month after end of intervention)

Study Sites (1)

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