Short-term Caregiver Psychotherapy

Phase 2

Completed

• Conditions: Caregiver Burden of People With Dementia
• Interventions: Behavioral: Psychotherapy

• Registration Number: NCT02175953
• Lead Sponsor: University of Rostock

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Primary Completion: 2015-11
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventiongroup	Psychotherapy	Psychotherapy

Primary Outcome Measures

Name	Time	Method
Change in perceived self-efficacy directly and 3 month after psychotherapeutical intervention and reduction of symptoms of depression	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 Outcome Measures

Name	Time	Method
reduction of perceived burden of care	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

Trial Locations

Locations (1)

University of Rostock; 🇩🇪 Rostock, MV, Germany