NCT02418806

Brief 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. This study aims to demonstrate that Alzheimer's patients' caregivers can decrease the feelings of burden after been involved in a group therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

February 6, 2015

Last Update Submit

January 19, 2016

Conditions

Alzheimer's Disease

Keywords

Family CaregiversPsychotherapy Group

Outcome Measures

Primary Outcomes (1)

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

    16 months

Secondary Outcomes (8)

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

    4 months and 16 months

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

    4 months and 16 months

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

    Baseline (0 months)

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

    4 months

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

    4 months - 16 months

  • +3 more secondary outcomes

Study Arms (3)

Therapy group with follow up sessions

EXPERIMENTAL

Weekly psychotherapy groups during 4 months with a monthly follow up period (12 months)

Behavioral: Psychotherapy groups

Therapy group without follow up sessions

EXPERIMENTAL

Weekly psychotherapy groups during 4 months

Behavioral: Psychotherapy groups

Active comparator group

ACTIVE COMPARATOR

Weekly self-help groups during 4 months with a monthly follow up period (12 months)

Behavioral: Self-help groups

Interventions

Psychotherapy groupsBEHAVIORAL
Therapy group with follow up sessionsTherapy group without follow up sessions
Self-help groupsBEHAVIORAL
Active comparator group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

AFA Barcelona

Barcelona, Spain

Location

Centro de día Vitalia

Barcelona, Spain

Location

AFA Burgos

Burgos, Spain

Location

AFA Castellón

Castellon, Spain

Location

AGUAFA

Guadassuar, Spain

Location

AFA Lleida

Lleida, Spain

Location

Centro de envejecimiento saludable

Málaga, Spain

Location

Fundació Ana Ribot

Pallejà, Spain

Location

AVAN

Sabadell, Spain

Location

AFATE

Santa Cruz de Tenerife, Spain

Location

AFA Terres de l'Ebre

Tortosa, Spain

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Sandra Poudevida, Psychologist

    BarcelonaBeta Brain Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2015

First Posted

April 16, 2015

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

September 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

ES(11)