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Short-term Caregiver Psychotherapy

NCT ID: NCT02175953

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Caregiver Burden of People With Dementia

Keywords

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caregiver burden stress depression dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Interventiongroup

Psychotherapy

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type BEHAVIORAL

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.

Waitling list group

waiting list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Center for Neurodegenerative Diseases (DZNE)

OTHER

Sponsor Role collaborator

University of Rostock

OTHER

Sponsor Role lead

Responsible Party

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Ingo Kilimann

Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

References

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Bedard 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. doi: 10.1093/geront/41.5.652.

Reference Type BACKGROUND
PMID: 11574710 (View on PubMed)

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.

Reference Type BACKGROUND

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. doi: 10.1093/oxfordjournals.aje.a112455.

Reference Type BACKGROUND
PMID: 900119 (View on PubMed)

Other Identifiers

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RO020

Identifier Type: -

Identifier Source: org_study_id