Acceptance and Commitment Therapy for Informal Caregivers of People With Dementia

NCT05064969 | Completed DMC

• 1 other identifier: NL77389.068.21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

No Specific Conditions

Keywords

Acceptance and Commitment Therapy; Informal caregivers; Internet-based intervention; Feasibility

Outcome Measures

Primary Outcomes (9)

• 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.

  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")

  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

  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.

  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)

  Will be assessed after completing the 9-week intervention

• Perceived feasibility

  Brief self-report feasibility questionnaire

  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

  After the last follow up assessment (6-month)

• Attrition

  Number of drop outs of study after collecting informed consent

  During the study (duration of study is expected to be 1.5 year)

• Perceived feasibility and acceptability

  Will be assessed qualitatively during coaching sessions

  9 (to 12) times. One telephone call per week over 9 (to 12) weeks of intervention.

Other Outcomes (5)

• Assessing change in psychological flexibility

  Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention.

• Assessing change in resilience

  Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention.

• Assessing change in values

  Will be assessed at baseline, after completing the intervention (9 to 12 weeks), 3month after intervention, and 6 month after intervention.

Study Arms (1)

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.

Behavioral: Blended intervention based in acceptance and commitment therapy

Interventions

Blended intervention based in acceptance and commitment therapy BEHAVIORAL

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.

Single-arm non-randomised

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229 ET, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37709305 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 1, 2021
• Study Start: May 12, 2022
• Primary Completion: May 20, 2023
• Study Completion: November 20, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

NL (1)