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Clinical Trials/NCT03391596
NCT03391596
Completed
Not Applicable

CareACT - Internet-based Intervention for Enhancing the Psychological Well-being of Elderly Caregivers

The Gerocenter Foundation for Research and Development1 site in 1 country151 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
The Gerocenter Foundation for Research and Development
Enrollment
151
Locations
1
Primary Endpoint
The Beck Depression Inventory (BDI-II): change from baseline to 4 months and 10 months
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
October 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The Gerocenter Foundation for Research and Development
Responsible Party
Principal Investigator
Principal Investigator

Riku Nikander

PhD, professor

The Gerocenter Foundation for Research and Development

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The Beck Depression Inventory (BDI-II): change from baseline to 4 months and 10 months

Time Frame: baseline, 4 months, post (10 months)

The BDI-II contains 21 questions about depressive symptoms and their severity. The scale ranges from 0 to 63 and the items are summed (0 to 13 indicates no or very few depressive symptoms, 14 to 19 indicates mild depression, 20 to 28 moderate depression, and 29 to 63 severe depression).

Secondary Outcomes

  • Sense of Coherence (SOC-13): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Acceptance and Action Questionnaire (AAQ-II): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • White Bear Suppression Inventory (WBSI): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Carers of Older People in Europe (COPE): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • WHO Quality of Life-BREF (WHOQOL-BREF): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Generalized Anxiety Disorder 7-item (GAD-7) scale: change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Short Physical Performance Battery (SPPB): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • The 'Short Five' (S5): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))
  • Experiential Avoidance in Caregiving Questionnaire (EACQ): change from baseline to 4 months and 10 months(baseline, 4 months, post (10 months))

Study Sites (1)

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