DementiaNCT06870474
Psychoeducational Intervention Against Support Groups for Caregivers
A study testing Psychoeducational intervention and Support group in people with Dementia, run by University of Salamanca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Psychoeducational intervention and Support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2019to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Psychology, University of Salamanca
Salamanca, Castille and León, 37008
About this study
Official title: Psychoeducational Intervention Against Support Groups for Caregivers: A Randomised Controlled Trial of Its Effectiveness
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
- Being tested
- Psychoeducational intervention, Support group, Control group
- Keywords
- dementia, effectiveness, family caregiver, psychoeducational intervention, support groups
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational interventionBehavioural
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 groupBehavioural
This intervention is a placebo group. It has the typical structure and characteristics of this type of intervention
Control groupBehavioural
Participants were not subject to any intervention. They received the psychoeducational intervention once the study had ended.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational intervention | Experimental | 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 Receives: Behavioral: Psychoeducational intervention |
| Support group | Placebo comparator | 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. Receives: Behavioral: Support group |
| Control group | Active comparator | Caregivers were not subject to any intervention. They received the psychoeducational intervention once the study had ended. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life. The World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE)
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
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Stress. The Perceived Stress Scale (PSS)
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.
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Depressive symptomology. The Center for Epidemiologic Studies-Depression Scale (CES-D)
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 .
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Burden. The Caregiver Burden Interview (CBI)
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.
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Dysfunctional thoughts. Dysfunctional Thoughts Questionnaire.
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.
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Social support. The Psychosocial Support Questionnaire (PSQ)
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.
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Social Skills. Social Skills Scale.
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.
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Self-efficacy in caregiving. The Revised Scale for Caregiving Self-Efficacy (RSCSE).
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.
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Rewarding activities. The Leisure Time Satisfaction (LTS) scale
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.
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Problem-solving skills. The Social Problem-Solving Inventory-Revised (SPSI-R-25)
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.
Measured: Baseline; after 8 weeks; 3 and 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start10 Jan 2019
- Primary completion25 Jun 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Jiménez García-Tizón, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870474
- Sponsor's protocol ID
- 454
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducational Intervention Against Support Groups for Caregivers: A Randomised Controlled Trial of Its Effectiveness
- ClinicalTrials.gov ID
- NCT06870474
- Acronym / sponsor ID
- 454
- Conditions
- Dementia
- Keywords
- dementia, effectiveness, family caregiver, psychoeducational intervention, support groups
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational intervention | Experimental | Behavioral: Psychoeducational interventionThe 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 |
| Support group | Placebo comparator | Behavioral: Support groupIn 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. |
| Control group | Active comparator | Behavioral: Control groupCaregivers were not subject to any intervention. They received the psychoeducational intervention once the study had ended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational interventionThe 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. | Behavioural | Psychoeducational intervention |
| Support groupThis intervention is a placebo group. It has the typical structure and characteristics of this type of intervention | Behavioural | Support group |
| Control groupParticipants were not subject to any intervention. They received the psychoeducational intervention once the study had ended. | Behavioural | Control group |
Primary outcome
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
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.
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 .
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational intervention and Support group in people with Dementia, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.