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Short-term Caregiver Psychotherapy

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ClinicalTrials.gov Identifier: NCT02175953
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
German Center for Neurodegenerative Diseases (DZNE)
Information provided by (Responsible Party):
Ingo Kilimann, 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.

Condition or disease Intervention/treatment Phase
Caregiver Burden of People With Dementia Behavioral: Psychotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Psychotherapeutical Short-term Intervention for Caregivers of Persons With Dementia
Study Start Date : June 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Interventiongroup
Psychotherapy
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.

No Intervention: Waitling list group
waiting list



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. reduction of perceived burden of care [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175953


Locations
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Germany
University of Rostock
Rostock, MV, Germany, 18147
Sponsors and Collaborators
University of Rostock
German Center for Neurodegenerative Diseases (DZNE)
Publications:
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Responsible Party: Ingo Kilimann, Neurologist, University of Rostock
ClinicalTrials.gov Identifier: NCT02175953    
Other Study ID Numbers: RO020
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by Ingo Kilimann, University of Rostock:
caregiver burden
stress
depression
dementia
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders