No Specific ConditionsACT-ICNCT05064969
Acceptance and Commitment Therapy for Informal Caregivers of People With Dementia
A study testing Blended intervention based in acceptance and commitment therapy in people with No Specific Conditions, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Dementia has a major impact on people with dementia and their family. Informal caregivers of people with dementia are at higher risk of developing depressive symptoms compared to informal caregivers of people with other chronic diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- No Specific Conditions
- What is being tested?
- Blended intervention based in acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 May 2022to 20 Nov 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult informal caregivers (at least 18 years old)
- Access to the internet and having a tablet or computer
- Self-identified primary informal caregiver of a person diagnosed with dementia
- Taking care of the care recipient at least once a week for a period of at least three months
- Obtained informed consent *General (psychological) support from case managers will not count as professional psychological support, and therefore, informal caregivers who receive support from the case managers will also be included.
Who cannot join
- Caregivers who report having a cognitive disorder in their clinical record will be excluded (based on self-report).
- Caregivers who receive psychotherapy or psychopharmacological treatment within the last 3 months will be excluded (based on self-report).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Blended Intervention Based on Acceptance and Commitment Therapy (ACT) for Informal Caregivers of People With Dementia- A Mixed-method Approach to Evaluate Feasibility, Acceptability and Preliminary Effectiveness
Dementia has a major impact on people with dementia and their family. Informal caregivers of people with dementia are at higher risk of developing depressive symptoms compared to informal caregivers of people with other chronic diseases. Therefore, supporting this group of informal caregivers is particularly important. With an online program based on Acceptance and Commitment Therapy (ACT), this study supports caregivers of people with dementia to lead a more meaningful and less stressful life. In addition to following the online program, caregivers are supported weekly by a coach, who helps to set goals, map important values in life, and take actions in relevant areas. The current study aims to examine the (1) feasibility and acceptability of the intervention and its procedure and; (2) preliminary effectiveness of the intervention on clinical outcomes (e.g. psychological flexibility and self-competence); and (3) maintenance of change after the intervention in short-and long-term follow-ups. This study includes a single-arm, non-randomized trial with a baseline assessment, a 9-week internet-based intervention period, a post-intervention assessment, and two follow-ups at 3 and 6 months. ACT is a promising form of therapy that has previously been shown to be effective in increasing the mental well-being of caregivers. However, this is the first study to combine online ACT modules, goal-setting, and weekly coaching for informal caregivers of people with dementia.
- Conditions
- No Specific Conditions
- Being tested
- Blended intervention based in acceptance and commitment therapy
- Keywords
- Acceptance and Commitment Therapy, Informal caregivers, Internet-based intervention, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended intervention based in acceptance and commitment therapyBehavioural
Blended intervention includes completing 9 e-modules consist of written material, videos, and assignments (one e-module per week) that can be completed over 9 to 12 weeks AND 9 (to 12 ) coaching sessions (telephone call). Weekly coaching will be offered by a motivational coach based in Maastricht University.
After the post-intervention assessments, individuals will receive monthly calls from the motivational coach as "booster sessions". Booster sessions will be received on monthly basis for a period of 6 months (one session per month) and until the last follow-up assessment. Communication with participants will take place online or via telephone.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm non-randomised | Experimental | This study includes a baseline assessment, a 9-week (with the possibility of extension to 12 weeks) blended intervention period, a post-intervention assessment, and two follow-ups at 3 and 6 months. Informal caregivers of people with dementia (with at least 18-year-old) with no restriction in terms of sex, educational level, or ethnic background will be included. Receives: Behavioral: Blended intervention based in acceptance and commitment therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing change in depression, anxiety, and stress
Measure the emotional states of depression, anxiety and stress will be assessed by DASS-21 self-report questionnaire. DASS-21 has three sections (7-items per section) that measure depression, anxiety, and stress on a 4-point Likert scale (0= the statement did not apply to me at all, 4= the statement applied to me very much or most of the time. DASS-21 is a validated scale that has been used in previous studies and has been recommended for measuring the dimensions of depression, anxiety, and stress.
Measured: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
Assessing change in sense of competence
Informal caregivers' sense of competence indicates the feelings of being capable of caring for a person with dementia. Short Sense of Competence Questionnaire (SSCQ) is a valid and reliable scale which has been used in previous studies with a similar target population and consists of seven items rated on a 5-point scale from 1 ("agree very strongly") to 5 ("disagree very strongly")
Measured: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
Assessing change in self efficacy
The Caregiver Self-Efficacy Scale (CSES) is based on a Dutch adaptation of the Lorig et al. CSES evaluates caregiver self-efficacy (four item) and service-use self-efficacy (five items) and item scores range from 1 (uncertain) to 10 (very certain). Previous research has shown that CSES is valid and reliable
Measured: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
Assessing change in perceived burden
Caregiver burden will be measured by a one-item questionnaire. The perseverance-time question will ask: if the informal caregiver's current situation persists, for how long (in month) the informal caregiver thinks they are able to maintain caregiving. This questionnaire is a good predictor for institutionalisation.
Measured: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
Acceptability
Will be assessed qualitatively during a semi-structured interview based on Program Participation Questionnaire (PPQ)
Measured: Will be assessed after completing the 9-week intervention
Perceived feasibility
Brief self-report feasibility questionnaire
Measured: Will be assessed after completing each module (during the intervention). 9 time for 9 modules.
Perceived feasibility and acceptability
Will be assessed qualitatively during the semi-structured interview
Measured: After the last follow up assessment (6-month)
Attrition
Number of drop outs of study after collecting informed consent
Measured: During the study (duration of study is expected to be 1.5 year)
Perceived feasibility and acceptability
Will be assessed qualitatively during coaching sessions
Measured: 9 (to 12) times. One telephone call per week over 9 (to 12) weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start12 May 2022
- Primary completion20 May 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for No Specific ConditionsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064969
- Sponsor's protocol ID
- NL77389.068.21
- Acronym
- ACT-IC
- Status last verified
- May 2024
- First submitted
- 3 Sep 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dara will be shared and handled based on the data management plan supported by the Clinical Trial Centre Maastricht.
Publications
Atefi GL, van Knippenberg RJM, Bartels SL, Verhey FR, de Vugt M. Blended intervention based on acceptance and commitment therapy for informal caregivers of people with dementia (ACT-IC): protocol of a mixed-methods feasibility study. BMJ Open. 2023 Sep 13;13(9):e070499. doi: 10.1136/bmjopen-2022-070499.
PubMed 37709305
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blended Intervention Based on Acceptance and Commitment Therapy (ACT) for Informal Caregivers of People With Dementia- A Mixed-method Approach to Evaluate Feasibility, Acceptability and Preliminary Effectiveness
- ClinicalTrials.gov ID
- NCT05064969
- Acronym / sponsor ID
- ACT-IC / NL77389.068.21
- Conditions
- No Specific Conditions
- Keywords
- Acceptance and Commitment Therapy, Informal caregivers, Internet-based intervention, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 1 Oct 2021 (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.
Dementia has a major impact on people with dementia and their family. Informal caregivers of people with dementia are at higher risk of developing depressive symptoms compared to informal caregivers of people with other chronic diseases. Therefore, supporting this group of informal caregivers is particularly important. With an online program based on Acceptance and Commitment Therapy (ACT), this study supports caregivers of people with dementia to lead a more meaningful and less stressful life. In addition to following the online program, caregivers are supported weekly by a coach, who helps to set goals, map important values in life, and take actions in relevant areas. The current study aims to examine the (1) feasibility and acceptability of the intervention and its procedure and; (2) preliminary effectiveness of the intervention on clinical outcomes (e.g. psychological flexibility and self-competence); and (3) maintenance of change after the intervention in short-and long-term follow-ups. This study includes a single-arm, non-randomized trial with a baseline assessment, a 9-week internet-based intervention period, a post-intervention assessment, and two follow-ups at 3 and 6 months. ACT is a promising form of therapy that has previously been shown to be effective in increasing the mental well-being of caregivers. However, this is the first study to combine online ACT modules, goal-setting, and weekly coaching for informal caregivers of people with dementia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm non-randomised | Experimental | Behavioral: Blended intervention based in acceptance and commitment therapyThis study includes a baseline assessment, a 9-week (with the possibility of extension to 12 weeks) blended intervention period, a post-intervention assessment, and two follow-ups at 3 and 6 months. Informal caregivers of people with dementia (with at least 18-year-old) with no restriction in terms of sex, educational level, or ethnic background will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult informal caregivers (at least 18 years old)
- Access to the internet and having a tablet or computer
- Self-identified primary informal caregiver of a person diagnosed with dementia
- Taking care of the care recipient at least once a week for a period of at least three months
- Obtained informed consent *General (psychological) support from case managers will not count as professional psychological support, and therefore, informal caregivers who receive support from the case managers will also be included.
Key exclusion criteria (2 listed)
- Caregivers who report having a cognitive disorder in their clinical record will be excluded (based on self-report).
- Caregivers who receive psychotherapy or psychopharmacological treatment within the last 3 months will be excluded (based on self-report).
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 |
|---|---|---|
| Blended intervention based in acceptance and commitment therapyBlended intervention includes completing 9 e-modules consist of written material, videos, and assignments (one e-module per week) that can be completed over 9 to 12 weeks AND 9 (to 12 ) coaching sessions (telephone call). Weekly coaching will be offered by a motivational coach based in Maastricht University. After the post-intervention assessments, individuals will receive monthly calls from the motivational coach as "booster sessions". Booster sessions will be received on monthly basis for a period of 6 months (one session per month) and until the last follow-up assessment. Communication with participants will take place online or via telephone. | Behavioural | Single-arm non-randomised |
Primary outcome
Assessing change in depression, anxiety, and stress
Time frame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
Measure the emotional states of depression, anxiety and stress will be assessed by DASS-21 self-report questionnaire. DASS-21 has three sections (7-items per section) that measure depression, anxiety, and stress on a 4-point Likert scale (0= the statement did not apply to me at all, 4= the statement applied to me very much or most of the time. DASS-21 is a validated scale that has been used in previous studies and has been recommended for measuring the dimensions of depression, anxiety, and stress.
Assessing change in sense of competence
Time frame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
Informal caregivers' sense of competence indicates the feelings of being capable of caring for a person with dementia. Short Sense of Competence Questionnaire (SSCQ) is a valid and reliable scale which has been used in previous studies with a similar target population and consists of seven items rated on a 5-point scale from 1 ("agree very strongly") to 5 ("disagree very strongly")
Assessing change in self efficacy
Time frame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
The Caregiver Self-Efficacy Scale (CSES) is based on a Dutch adaptation of the Lorig et al. CSES evaluates caregiver self-efficacy (four item) and service-use self-efficacy (five items) and item scores range from 1 (uncertain) to 10 (very certain). Previous research has shown that CSES is valid and reliable
Assessing change in perceived burden
Time frame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
Caregiver burden will be measured by a one-item questionnaire. The perseverance-time question will ask: if the informal caregiver's current situation persists, for how long (in month) the informal caregiver thinks they are able to maintain caregiving. This questionnaire is a good predictor for institutionalisation.
Acceptability
Time frame: Will be assessed after completing the 9-week intervention
Will be assessed qualitatively during a semi-structured interview based on Program Participation Questionnaire (PPQ)
Perceived feasibility
Time frame: Will be assessed after completing each module (during the intervention). 9 time for 9 modules.
Brief self-report feasibility questionnaire
Perceived feasibility and acceptability
Time frame: After the last follow up assessment (6-month)
Will be assessed qualitatively during the semi-structured interview
Attrition
Time frame: During the study (duration of study is expected to be 1.5 year)
Number of drop outs of study after collecting informed consent
Perceived feasibility and acceptability
Time frame: 9 (to 12) times. One telephone call per week over 9 (to 12) weeks of intervention.
Will be assessed qualitatively during coaching sessions
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 10 May 2024.
- Derived from this study: PubMed 37709305Atefi GL, van Knippenberg RJM, Bartels SL, Verhey FR, de Vugt M. Blended intervention based on acceptance and commitment therapy for informal caregivers of people with dementia (ACT-IC): protocol of a mixed-methods feasibility study. BMJ Open. 2023 Sep 13;13(9):e070499. doi: 10.1136/bmjopen-2022-070499.
- Individual participant dataSharing planned: Yes. Dara will be shared and handled based on the data management plan supported by the Clinical Trial Centre Maastricht.
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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 Blended intervention based in acceptance and commitment therapy in people with No Specific Conditions, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 2 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 10 May 2024. 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 Netherlands. 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. 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?
Assessing change in depression, anxiety, and stress (time frame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064969, which also lists 1 linked publication.
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 10 May 2024.