Clinical trial NCT03391596: Internet-based Intervention for Enhancing the Psychological Well-being of Elderly Caregivers
Official title: CareACT - Internet-based Intervention for Enhancing the Psychological Well-being of Elderly Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Psychological Distress
Quality of Life
Keywords: Family caregivers
Depressive symptoms
Psychological wellbeing
Internet-based intervention
Acceptance and Commitment Therapy
Lead sponsor: The Gerocenter Foundation for Research and Development
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 151
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine whether an Internet-based Acceptance and Commitment Therapy (ACT) intervention is effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers. In our study, we will compare 1) the experimental Internet-based ACT group to 2) standardized institutional rehabilitation carried out in rehabilitation centers and to 3) support provided by voluntary family caregiver associations

Detailed description: It is well-known that stress, low quality of life and depression are relatively common problems among family caregivers. The proportion of elderly family caregivers is rapidly increasing which emphasizes the need for new support systems. Internet-delivered psychological interventions are one possible approach, offering benefits as they are more easily to achieve for family caregivers who often are home-bound with their relatives.

This study will examine whether an Internet-based Acceptance and Commitment Therapy intervention would be effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers.The family caregivers' depressive symptoms, perceived burden, anxiety, quality of life, psychological flexibility, personality and physical performance will be studied by a quasi-experimental study design comparing three groups of family caregivers (Group 1, experimental: Internet-based ACT intervention; Group 2, active comparator: Standardized institutional rehabilitation in a rehabilitation center; Group 3, other: Support given by voluntary family caregiver associations). Data collection will be performed at three time points: pre, 4 months and post (10 months).

Secondly, we also aim to examine demographics and psychological variables that could predict change in depression and perceived burden over time (pre, 4 months and post (10 months). A further aim of the study is to examine potential mediators on the effect of the interventions including psychological flexibility and suppression of thoughts. Moreover, we aim to study user experiences and satisfaction of the Internet-based program, i.e., how the family caregivers experience and accept the web-based ACT intervention.

Eligibility criteria: Inclusion Criteria for all groups:

* family caregiver
* at least 60 years of age

Inclusion Criteria for the experimental and active comparator group - depressive symptoms and/or psychological distress

Exclusion Criteria for all groups:

* parallel psychological treatment
* severe mental disorder

Additional inclusion criteria for the experimental group:

- computer and Internet connection or willingness to use a tablet provided by the study

Primary outcomes:
measure: The Beck Depression Inventory (BDI-II): change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
Secondary outcomes:
measure: Carers of Older People in Europe (COPE): change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
measure: WHO Quality of Life-BREF (WHOQOL-BREF): change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
measure: Generalized Anxiety Disorder 7-item (GAD-7) scale: change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
measure: Sense of Coherence (SOC-13): change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
measure: Acceptance and Action Questionnaire (AAQ-II): change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
measure: Experiential Avoidance in Caregiving Questionnaire (EACQ): change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
measure: White Bear Suppression Inventory (WBSI): change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
measure: The 'Short Five' (S5): change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
measure: Short Physical Performance Battery (SPPB): change from baseline to 4 months and 10 months
timeFrame: baseline, 4 months, post (10 months)
Other outcomes:
measure: User experiences questionnaire (developed by the research group)
timeFrame: 4 months (only experimental group)
measure: Closing interview (developed by the research group) questions
timeFrame: 4 months (only experimental group)
Locations:
city: Jyväskylä
country: Finland
facility: Gerocenter Foundation for Research and Development
Study officials:
affiliation: Gerocenter Foundation for Research and Development
name: Riku Nikander, Professor
role: STUDY_DIRECTOR
References:
citation: Lappalainen P, Pakkala I, Nikander R. CareACT - internet-based intervention for enhancing the psychological well-being of elderly caregivers - a study protocol of a controlled trial. BMC Geriatr. 2019 Mar 5;19(1):72. doi: 10.1186/s12877-019-1071-9.