Clinical trial NCT05064969: Acceptance and Commitment Therapy for Informal Caregivers of People With Dementia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Specific Conditions
Keywords: Acceptance and Commitment Therapy
Informal caregivers
Internet-based intervention
Feasibility
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Assessing change in depression, anxiety, and stress
timeFrame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
measure: Assessing change in sense of competence
timeFrame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
measure: Assessing change in self efficacy
timeFrame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
measure: Assessing change in perceived burden
timeFrame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention..
measure: Acceptability
timeFrame: Will be assessed after completing the 9-week intervention
measure: Perceived feasibility
timeFrame: Will be assessed after completing each module (during the intervention). 9 time for 9 modules.
measure: Perceived feasibility and acceptability
timeFrame: After the last follow up assessment (6-month)
measure: Attrition
timeFrame: During the study (duration of study is expected to be 1.5 year)
measure: Perceived feasibility and acceptability
timeFrame: 9 (to 12) times. One telephone call per week over 9 (to 12) weeks of intervention.
Secondary outcomes:
Other outcomes:
measure: Assessing change in psychological flexibility
timeFrame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention.
measure: Assessing change in resilience
timeFrame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention.
measure: Assessing change in values
timeFrame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention.
measure: Assessing change in committed actions
timeFrame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention.
measure: Assessing change in gaol attainment
timeFrame: Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention.
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References: