AzTrials
AzTrials

Alzheimer's DiseasecuiDemNCT02418806

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

A study testing Psychotherapy groups and Self-help groups in people with Alzheimer's Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 11 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
Psychotherapy groups and Self-help groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
11 sitesSpain
Study dates
Jan 2014to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Spain11 sites

  • AFA Barcelona

    Barcelona

  • Centro de día Vitalia

    Barcelona

  • AFA Burgos

    Burgos

  • AFA Castellón

    Castellon

  • AGUAFA

    Guadassuar

  • AFA Lleida

    Lleida

  • Centro de envejecimiento saludable

    Málaga

  • Fundació Ana Ribot

    Pallejà

  • AVAN

    Sabadell

  • AFATE

    Santa Cruz de Tenerife

  • AFA Terres de l'Ebre

    Tortosa

Other trials in Spain

About this study

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.

Being tested
Psychotherapy groups, Self-help groups
Keywords
Family Caregivers, Psychotherapy Group
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychotherapy groupsBehavioural

  • Self-help groupsBehavioural

Study groups in NCT02418806
Study groupRoleWhat they receive
Therapy group with follow up sessionsExperimentalWeekly psychotherapy groups during 4 months with a monthly follow up period (12 months)
Receives: Behavioral: Psychotherapy groups
Therapy group without follow up sessionsExperimentalWeekly psychotherapy groups during 4 months
Receives: Behavioral: Psychotherapy groups
Active comparator groupActive comparatorWeekly self-help groups during 4 months with a monthly follow up period (12 months)
Receives: Behavioral: Self-help groups

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 16 months

Secondary outcomes (8)

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

    Measured: 4 months and 16 months

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

    Measured: 4 months and 16 months

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

    Measured: Baseline (0 months)

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

    Measured: 4 months

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

    Measured: 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.

    Measured: 4 months - 16 months

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

    Measured: 4 months - 16 months

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

    Measured: 4 months - 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionJul 2014
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02418806
Sponsor's protocol ID
cuiDem/FBB-0113
Acronym
cuiDem
Status last verified
Jan 2016
First submitted
6 Feb 2015
Last updated
20 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Psychotherapy groups and Self-help groups in people with Alzheimer's Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 11 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview. (time frame: 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02418806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in