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Completed

NCT Number: NCT02175953

Short-term Caregiver Psychotherapy

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.

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Key information

Conditions

Caregiver Burden of People With Dementia Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Depression Mental Disorders Nervous System Diseases Neurocognitive Disorders Stress, Psychological

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18147, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychotherapy

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Collaborators

  • German Center for Neurodegenerative Diseases (DZNE)

Registry information

Official study title

Psychotherapeutical Short-term Intervention for Caregivers of Persons With Dementia

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 26, 2014
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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