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Completed

NCT Number: NCT06870474

Psychoeducational Intervention Against Support Groups for Caregivers

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Psychology, University of Salamanca

Salamanca, Castille and León, 37008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Psychoeducational intervention

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

Behavioral

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

Control Group

Behavioral

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

Primary outcomes

  1. Quality of life. The World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE)

    Time frame: 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

  2. Stress. The Perceived Stress Scale (PSS)

    Time frame: 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.

  3. Depressive symptomology. The Center for Epidemiologic Studies-Depression Scale (CES-D)

    Time frame: 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 .

  4. Burden. The Caregiver Burden Interview (CBI)

    Time frame: 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.

  5. Dysfunctional thoughts. Dysfunctional Thoughts Questionnaire.

    Time frame: 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.

  6. Social support. The Psychosocial Support Questionnaire (PSQ)

    Time frame: 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.

  7. Social Skills. Social Skills Scale.

    Time frame: 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.

  8. Self-efficacy in caregiving. The Revised Scale for Caregiving Self-Efficacy (RSCSE).

    Time frame: 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.

  9. Rewarding activities. The Leisure Time Satisfaction (LTS) scale

    Time frame: 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.

  10. Problem-solving skills. The Social Problem-Solving Inventory-Revised (SPSI-R-25)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

Psychoeducational Intervention Against Support Groups for Caregivers: A Randomised Controlled Trial of Its Effectiveness

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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