Psychoeducational Intervention Against Support Groups for Caregivers

Not Applicable

Completed

• Conditions: Dementia

• Registration Number: NCT06870474
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-10
• Primary Completion: 2019-06-25
• Study Completion: 2019-11-25
• Study First Submitted: 2025-02-27
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life. The World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE)	Baseline; after 8 weeks; 3 and 6 months follow up	It was assessed using the World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE). It contains 13 items in a Likert-type format with five options consisting of a combination of bipolar and unipolar responses. A higher score corresponds to a better quality of life
Stress. The Perceived Stress Scale (PSS)	Baseline; after 8 weeks; 3 and 6 months follow up	Use was made of the Perceived Stress Scale (PSS). It consists of 14 items which assesses the level of stress the subject has perceived over the past month (from 0 = never to 4 = very often). The higher the direct score recorded, the higher the level of perceived stress.
Depressive symptomology. The Center for Epidemiologic Studies-Depression Scale (CES-D)	Baseline; after 8 weeks; 3 and 6 months follow up	This was assessed through the Center for Epidemiologic Studies-Depression Scale (CES-D). It consists of 20 items which assess whether an individual has manifested any of the symptoms of depression during the preceding week (from 0 = rarely or never to 3 = mostly or all the time). A higher score corresponds to a greater depressive symptomology .
Burden. The Caregiver Burden Interview (CBI)	Baseline; after 8 weeks; 3 and 6 months follow up	It was assessed using the Caregiver Burden Interview (CBI). It consists of 22 items which measures the extent to which caregivers perceive that their duties put a burden on their health, personal and social lives, finances, and emotional wellbeing (from 1 = never through to 5 = almost always). A higher score signals a greater burden.
Dysfunctional thoughts. Dysfunctional Thoughts Questionnaire.	Baseline; after 8 weeks; 3 and 6 months follow up	The assessment used the Dysfunctional Thoughts Questionnaire. It measures the thoughts, opinions, values and attitudes of the caregivers of dependent elderly people (from 0 = completely disagree to 4 = completely agree) through 16 items. A higher score indicates the greater presence of obstacles for properly coping with caregiving.
Social support. The Psychosocial Support Questionnaire (PSQ)	Baseline; after 8 weeks; 3 and 6 months follow up	This involved an adapted version of the Psychosocial Support Questionnaire (PSQ). It consists of six items (from 0 = never to 3 = always). The higher the score, the greater the perception of psychosocial support.
Social Skills. Social Skills Scale.	Baseline; after 8 weeks; 3 and 6 months follow up	It was used the Social Skills Scale. It rates assertive behaviour and social skills (from 1 = it does not reflect me at all; it hardly ever happens to me, or I would not do it, to 4 = I completely agree and I would feel this way or act accordingly in most cases) through 33 items. The higher the global score, the greater the social skills.
Self-efficacy in caregiving. The Revised Scale for Caregiving Self-Efficacy (RSCSE).	Baseline; after 8 weeks; 3 and 6 months follow up	The assessment used the Revised Scale for Caregiving Self-Efficacy (RSCSE). It assesses caregivers' own measure of their perceived self-efficacy for caregiving tasks through 15 items. It contains three subscales: Obtaining Respite, Responding to Disruptive Patient Behaviour, and Controlling Upsetting Thoughts. High scores reflect a significant level of self-efficacy.
Rewarding activities. The Leisure Time Satisfaction (LTS) scale	Baseline; after 8 weeks; 3 and 6 months follow up	This was assessed thought an adapted version of the Leisure Time Satisfaction (LTS) scale. It consists of six items related to different leisure activities. It measures the frequency of performance (from 0 = not at all to 2 = a lot for) and the degree of satisfaction (from 0 = not at all satisfied to 2 = very) with it regarding rewarding activities in the past month. These are two scales with the same items. Higher scores correspond to a greater frequency and satisfaction with these activities.
Problem-solving skills. The Social Problem-Solving Inventory-Revised (SPSI-R-25)	Baseline; after 8 weeks; 3 and 6 months follow up	This involved the Spanish version of the short form of the Social Problem-Solving Inventory-Revised (SPSI-R-25). It measures problem-solving skills (from 0 = not at all true to 4 = completely true). Higher scores indicate better social problem-solving.

Trial Locations

Locations (1)

Faculty of Psychology, University of Salamanca; 🇪🇸 Salamanca, Castilla y León, Spain