Clinical trial NCT06870474: Psychoeducational Intervention Against Support Groups for Caregivers
Official title: Psychoeducational Intervention Against Support Groups for Caregivers: A Randomised Controlled Trial of Its Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
effectiveness
family caregiver
psychoeducational intervention
support groups
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Quality of life. The World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE)
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
measure: Stress. The Perceived Stress Scale (PSS)
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
measure: Depressive symptomology. The Center for Epidemiologic Studies-Depression Scale (CES-D)
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
measure: Burden. The Caregiver Burden Interview (CBI)
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
measure: Dysfunctional thoughts. Dysfunctional Thoughts Questionnaire.
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
measure: Social support. The Psychosocial Support Questionnaire (PSQ)
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
measure: Social Skills. Social Skills Scale.
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
measure: Self-efficacy in caregiving. The Revised Scale for Caregiving Self-Efficacy (RSCSE).
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
measure: Rewarding activities. The Leisure Time Satisfaction (LTS) scale
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
measure: Problem-solving skills. The Social Problem-Solving Inventory-Revised (SPSI-R-25)
timeFrame: Baseline; after 8 weeks; 3 and 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Faculty of Psychology, University of Salamanca
state: Castilla y León
Study officials:
References: