Psychoeducational Intervention Against Support Groups for Caregivers

NCT ID: NCT06870474

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2019-11-25

Brief Summary

Background: To explore the effectiveness of a psychoeducational intervention against support groups and the usual care in caregivers. Providing care involves major changes in the lives of caregivers, with far-reaching repercussions. There is evidence that acting upon its mediator variables reduces its effects.

Methods: A randomised controlled trial will be carried out. The study will be conducted at the Faculty of Psychology of the University of Salamanca (USAL) in Spain. Family caregivers of people with dementia will participate in this study. The participants will be divided into three groups: the intervention group (IG), which will undergo a psychoeducational intervention programme, the support group (SG) (control group - placebo), which will undergo a support group intervention programme, and the control group-waiting lists (CG), which will only be assessed at the different measurements points, and after the end of the programme they will be offered the intervention of the experimental group. The programme (IG) will comprise eight sessions over a period of two months. All participants will be assessed at the outset and conclusion of the study, as well as after three and six months, during which time data regarding their socio-demographic characteristics and responses to the different scales will be collected. Both mediator and negative outcome variables will be assessed.

Discussion: Effective interventions need to be developed to improve the biopsychosocial state of caregivers. The presented psychoeducational intervention may help family caregivers because it could be more effective than others. The psychoeducational intervention has the aim of improving quality of life, problem-solving and social skills, leisure time, self-efficacy and social support of caregivers; and decreasing their depressive symptomology, dysfunctional thoughts, burden and stress.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Psychoeducational intervention

The content was based on prior interventions, considering the caregivers' active involvement, adapting to their specific needs, addressing multiple areas of need, sporadic interventions over the course of the care, and the priority-based adjustment of the intensity or approach. This structure was adopted in all the sessions: 1) Review of homework, 2) Theoretical content, 3) Practical application of theoretical content, 4) Assignment of homework, and 5) Queries (see Table S1 of the supplementary material). The intervention involves eight 90-minute sessions held on a weekly basis

Group Type: EXPERIMENTAL

Psychoeducational intervention

Intervention Type: BEHAVIORAL

The psychoeducational intervention has the aim of improving quality of life, problem-solving and social skills, leisure time, self-efficacy and social support of caregivers; and decreasing their depressive symptomology, dysfunctional thoughts, burden and stress. Both mediator and outcome variables will be contemplated.

Support group

In the sessions, caregivers share concerns and experiences with other group members, expressing feelings and fears. There is reciprocity, as they are listened to, but at the same time information is provided, ideas, strategies and skills are shared to face daily caregiving situations. The sessions are not structured, on the contrary, the topics are proposed and developed by the caregivers and the professional has only a moderating role. The intervention involves eight 90-minute sessions held on a weekly basis.

Group Type: PLACEBO_COMPARATOR

Support group

Intervention Type: BEHAVIORAL

This intervention is a placebo group. It has the typical structure and characteristics of this type of intervention

Control group

Caregivers were not subject to any intervention. They received the psychoeducational intervention once the study had ended.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: BEHAVIORAL

Participants were not subject to any intervention. They received the psychoeducational intervention once the study had ended.

Interventions

Psychoeducational intervention

The psychoeducational intervention has the aim of improving quality of life, problem-solving and social skills, leisure time, self-efficacy and social support of caregivers; and decreasing their depressive symptomology, dysfunctional thoughts, burden and stress. Both mediator and outcome variables will be contemplated.

Intervention Type: BEHAVIORAL

Support group

This intervention is a placebo group. It has the typical structure and characteristics of this type of intervention

Intervention Type: BEHAVIORAL

Control group

Participants were not subject to any intervention. They received the psychoeducational intervention once the study had ended.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Be the main caregiver of a family member with dementia, either as a spouse or as an offspring.
• No previous involvement in studies/programmes like this one.
• The family member lives at home (not institutionalised).

Exclusion Criteria

• Not be the main caregiver of a family member with dementia, either as a spouse or as an offspring.
• Previous involvement in studies/programmes like this one.
• The family member not lives at home (the family member is institutionalised).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Sara Jiménez García-Tizón

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Psychology, University of Salamanca

Salamanca, Castille and León, Spain

Countries

Spain

Other Identifiers

454

Identifier Type: -

Identifier Source: org_study_id