NCT01762618

Brief Summary

A randomized controlled trial 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 14 sessions of a cognitive-behavioral psychological group therapy. This study aims to demonstrate that Alzheimer's patients' caregivers can benefit from group counseling, with an improvement in mood state, quality of life, perceived burden and a decrease in anxiety and depression. Two evaluations will be done: before the therapy sessions (basal) and when intervention is finished (final).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

3 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, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

December 18, 2012

Last Update Submit

July 8, 2014

Conditions

Psychological Support to Caregivers of Azlheimer's Patients

Keywords

Group Cognitive Behavior Therapy, Alzheimer's disease, Caregivers¡

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in POMS Scale ("Profile of Mood States")

    Change from baseline compared to the control and active arms using the Profile of Mood State (POMS) validated in structure and content for the Spanish language. This scale is a popular instrument for mood evaluation. It comprises 44 items (with a Likert response from 0 to 4), representing six conceptual dimensions: tension, depression,anger, vigour, fatigue and friendliness.

    Pre-treatment and 4 weeks post treatment

Secondary Outcomes (1)

  • Change from baseline compared to the control and active arms using the Martin and cols. scale to assess the overload level of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia.

    Pre-treatment and 4 weeks post treatment

Other Outcomes (2)

  • Change from baseline compared to the control and active arms using the SF-36 v2 (Short Form-36 Health Survey), a questionnaire that measures the Quality of Life related to Health.

    Pre-treatment and 4 weeks post treatment

  • Change from baseline compared to the control and active arms using the Hospital Anxiety and Depression Scale (HADS)

    Pre-treatment and 4 weeks post treatment

Study Arms (2)

Cognitive Behavioral Therapy Group

EXPERIMENTAL

14 therapy sessions, once a week for one and a half hours.

Behavioral: Cognitive Behavioral Therapy Group

Control Group

NO INTERVENTION

Social support for caregiver (through the social worker) as usual. The social worker gives information when they considered that there is a social economic risk or upon request by the caregiver.

Interventions

Cognitive Behavioral Therapy GroupBEHAVIORAL

Therapy Groups

Also known as: 14 therapy sessions, once a week for one and a half hours.
Cognitive Behavioral Therapy Group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be the principal caregiver of a person with Alzheimer's disease
  • The patient has a possible or probable diagnosis of Alzheimer's disease made for an Accredited Dementia Unit.
  • The patient score in the Global Deterioration Scale must be: 4, 5 or 6A.
  • The caregiver must dedicate at least 5 hours a day or spend a significant part of his time to care-related tasks
  • The caregiver must sign the Informed Consent

You may not qualify if:

  • To receive a financial compensation for the care of the patient
  • The caregiver or the patient has a psychiatric illness according to the DSM-IV TR, such that the investigator considers it might hinder the dynamics of the group and affect the objectives of the study
  • Be receiving some type of formal counseling (conducted by a therapist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital del Carme

Badalona, Barcelona, 0, Spain

Location

Primary Assistant Center Les Corts

Barcelona, Catalonia, Spain

Location

Primary Assistant Center Sarrià

Barcelona, Catalonia, Spain

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Sandra Poudevida, PhD

    Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 18, 2012

First Posted

January 8, 2013

Study Start

January 1, 2012

Primary Completion

April 1, 2013

Study Completion

July 1, 2013

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

ES(3)