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Short-term Caregiver Psychotherapy

Primary Purpose

Caregiver Burden of People With Dementia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
University of Rostock
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caregiver Burden of People With Dementia focused on measuring caregiver burden, stress, depression, dementia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rostock

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventiongroup

Waitling list group

Arm Description

Psychotherapy

waiting list

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

reduction of perceived burden of care
We will be using the Zarit-Burden-Interview to measure the perceived burden of care

Full Information

First Posted
June 24, 2014
Last Updated
October 25, 2016
Sponsor
University of Rostock
Collaborators
German Center for Neurodegenerative Diseases (DZNE)
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1. Study Identification

Unique Protocol Identification Number
NCT02175953
Brief Title
Short-term Caregiver Psychotherapy
Official Title
Psychotherapeutical Short-term Intervention for Caregivers of Persons With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rostock
Collaborators
German Center for Neurodegenerative Diseases (DZNE)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden of People With Dementia
Keywords
caregiver burden, stress, depression, dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventiongroup
Arm Type
Experimental
Arm Description
Psychotherapy
Arm Title
Waitling list group
Arm Type
No Intervention
Arm Description
waiting list
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in perceived self-efficacy directly and 3 month after psychotherapeutical intervention and reduction of symptoms of depression
Description
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
Time Frame
before intervention, 0 and 3 month after end of intervention
Secondary Outcome Measure Information:
Title
reduction of perceived burden of care
Description
We will be using the Zarit-Burden-Interview to measure the perceived burden of care
Time Frame
before intervention, 0 and 3 month after end of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Rostock
City
Rostock
State/Province
MV
ZIP/Postal Code
18147
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
11574710
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
900119
Citation
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.
Results Reference
background

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Short-term Caregiver Psychotherapy

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