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NCT Number: NCT02418806

Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres

An experimental study designed to test the effectiveness of a psychological intervention based on group therapy for the caregivers of Alzheimer's disease patients. The intervention consists of 16 sessions of a cognitive-behavioral psychological group therapy. This study aims to demonstrate that Alzheimer's patients' caregivers can decrease the feelings of burden after been involved in a group therapy.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AFA Barcelona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Main caregiver of an Alzheimer Disease Patient.
  • Alzheimer Disease Patient with mild/severe cognitive impairment.
  • High compliance to therapy sessions.
  • Sign informed consent.

Exclusion criteria

  • Low commitment to develop all study phases.
  • Caregiver activity remunerated.
  • Caregiver with psychiatric disorders that can affect the development of the sessions.
  • Caregivers who have received psychological care during last year.

Treatment and study plan

Psychotherapy groups

Behavioral

Self-help groups

Behavioral

Primary outcomes

  1. Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.

    Time frame: 16 months

Secondary outcomes

  1. Change in caregiver burden from baseline compared to the control and active arms measured by Zarit Burden Interview.

    Time frame: 4 months and 16 months

  2. Change in anxiety and depression from baseline compared to the control and active arms measured by Goldberg Scale.

    Time frame: 4 months and 16 months

  3. Descriptive analysis of the caregivers' characteristics (sociodemographics, relation wih the AD patient).

    Time frame: Baseline (0 months)

  4. Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1.

    Time frame: 4 months

  5. Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients.

    Time frame: 4 months - 16 months

  6. Change in quality of life from baseline compared to the control and active arms measured by Casp-19 and SF-36 questionnaires.

    Time frame: 4 months - 16 months

  7. Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale.

    Time frame: 4 months - 16 months

  8. Change in functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire.

    Time frame: 4 months - 16 months

Sponsors and collaborators

Lead sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Other

Registry information

Acronym: cuiDem

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 16, 2015
Registry last updated
Jan 20, 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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