Overview

This trial has been completed.

Condition caregiver burden of people with dementia
Treatment psychotherapy
Phase phase 2
Sponsor University of Rostock
Collaborator German Center for Neurodegenerative Diseases (DZNE)
Start date June 2014
End date November 2015
Trial size 13 participants
Trial identifier NCT02175953, RO020

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Psychotherapy
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)
waiting list

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
reduction of perceived burden of care
time frame: before intervention, 0 and 3 month after end of intervention

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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

Additional Information

Official title Psychotherapeutical Short-term Intervention for Caregivers of Persons With Dementia
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Rostock.