The primary objective of this study is to evaluate the feasibility and acceptability of the blended ACT-based intervention among informal caregivers of PWD.The secondary objectives are to evaluate (i) the preliminary effectiveness of the blended ACT…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
No specific condition of the informal Caregivers of people with Dementia will be studied.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures include:
- Depression, anxiety, and stress (DASS-21)
- Short Sense of Competence Questionnaire (SSCQ-7)
- Burden (The perseverance-time single-item)
- The Caregiver Self-Efficacy Scale (CSES-9)
Secondary outcome
Process measures include:
- Value: Valued Living Questionnaire (VLQ)
- Psychological flexibility: Acceptance and Action Questionnaire II (AAQ-II)
- Resilience: Flexibility Index Test (FIT-60)
- Committed action: Engaged Living Scale (ELS)
- Goal-attainment scaling will be assessed qualitatively
Background summary
Informal caregivers of people with dementia (PwD) invest time, emotion, and
effort in their caregiving responsibilities. Due to various care demands,
informal caregivers may experience substantial negative mental health effects
such as burden, stress, depression, and anxiety. Therefore, they are holding a
unique position of both providing and needing support.
Acceptance and commitment therapy (ACT) is a transdiagnostic and evidence-based
approach that empowers individuals to change their behavior toward value-based
activities. To date, ACT can be applied not only in face-to-face sessions but
also via self-guided online programs, which increases the individual
time-flexibility and might be particularly suitable for caregivers of PwD.
Moreover, ACT has shown promise in improving individuals* mental health and
overall wellbeing. However, only a small number of studies investigated ACT in
older caregivers which is usually found in the context of dementia care.
In addition to ACT, setting realistic goals toward value-based activities
supports individuals to orient their actions and subsequently their behavior
toward a more meaningful and less distressing life. This strategy might support
informal caregivers of PwD further to balance the care demands with their
individual needs. However, engaging with life values, defining goals, and
taking action toward those values might be challenging and yet require further
motivation for informal caregivers of PwD.
Therefore, a web-based ACT intervention blended with complementary components
including collaborative goal-setting and motivational coaching might enable
informal caregivers of PwD to live a more meaningful and less distressing life.
Study objective
The primary objective of this study is to evaluate the feasibility and
acceptability of the blended ACT-based intervention among informal caregivers
of PWD.
The secondary objectives are to evaluate (i) the preliminary effectiveness of
the blended ACT-based intervention on clinical outcomes (e.g. psychological
flexibility), and (ii) maintenance of changes after the intervention in short-
and long-term follow ups.
Study design
This study includes a single-arm, non-randomised 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.
Intervention
All eligible and consenting informal caregivers of PwD will be asked to
participate in an individual goal-setting session with a motivational coach.
Afterward, participants follow the internet-delivered ACT-based modules on a
digital platform called *Embloom*. A total of 9 modules (one module per week)
can be completed over 9 to 12 weeks. During the intervention, the motivational
coach will contact the participants weekly to encourage them to follow their
goals and stay engaged with the modules. After the intervention, 6 monthly
booster sessions (one session per month) will be provided by the motivational
coach to motivate the informal caregivers to continue their value-based
activities or revisit the ACT modules, if needed.
Before and after the intervention as well as at 3-and 6-month follow up,
participants will be asked to fill out a number of retrospective
questionnaires. Furthermore, a semi-structured interview will be conducted to
assess the user experience, feasibility, and acceptability of the intervention.
Study burden and risks
Although the risk of participation in this study can be considered
minimal/negligible, engaging with technology and internet-based intervention
might be confusing or require effort from older informal caregivers.
Furthermore, informal caregivers should follow the modules, fill in the
exercises, and at the same time stay actively engaged with their SMART goals.
Being called weekly by a motivational coach and staying in touch 6 months after
the intervention might be associated with a considerable perceived burden.
Individuals who choose to participate in the blended ACT intervention will
receive the potential benefits associated with the intervention in terms of
their clinical, functional, and social functioning to live a more meaningful
and less distressing life. Moreover, an incentive voucher with a value of 25¤
will be sent to the research participants who complete the study.
Dr. Tanslaan 12
Maastricht 6229 ET
NL
Dr. Tanslaan 12
Maastricht 6229 ET
NL
Listed location countries
Age
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 for at least once a week for a period of at
least three months
- Obtained informed consent
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).
*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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT05064969 |
CCMO | NL77389.068.21 |