Short-term Caregiver Psychotherapy

Caregiver Burden of People With Dementia Clinical Trial

Official title:

Psychotherapeutical Short-term Intervention for Caregivers of Persons With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175953
• Other study ID #: RO020
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2014
• Last updated: October 25, 2016
• Start date: June 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Caregiver Burden of People With Dementia
• Dementia

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Rostock	Rostock	MV

Sponsors (2)

Lead Sponsor	Collaborator
University of Rostock	German Center for Neurodegenerative Diseases (DZNE)

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Bédard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. — View Citation

Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK.

Weissman MM, Sholomskas D, Pottenger M, Prusoff BA, Locke BZ. Assessing depressive symptoms in five psychiatric populations: a validation study. Am J Epidemiol. 1977 Sep;106(3):203-14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in perceived self-efficacy directly and 3 month after psychotherapeutical intervention and reduction of symptoms of depression	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	No
Secondary	reduction of perceived burden of care	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	No