Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study

Quality of Life Clinical Trial

— BRiC  

Official title:

A Randomised Controlled Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444312
• Other study ID #: BRiC2015
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: October 5, 2015
• Start date: June 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

A randomised controlled trial that will compare the effects of a brief benefit -finding writing intervention with an active control condition on quality of life and psychological health among informal caregivers.

Description:

A double-blind, randomized controlled parallel group study design with an equal 1:1 allocation ratio will be employed. This study will compare the effect of a brief benefit finding writing intervention with a control condition among caregivers. Caregivers currently caring for people with mental and physical disabilities will be randomised into a two-week, a) a benefit writing group or b) a control writing group. Caregivers will complete self-report measures relating to their care-recipient and themselves (e.g., illness type, and sociodemographics) and psychometric measures of benefit finding (primary outcome), psychological distress and quality of life(secondary outcomes). These will be assessed via online software at baseline, immediate post-test and at 3 month follow-up. Additionally, expectations and fidelity indices will be assessed and qualitative commentary on participation experiences gathered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be over the age of 18

• Must identify as caring for a family member, friend or relative

• Must be living in Ireland

Exclusion Criteria:

• If the person cared for is living in institutional care

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychological Distress
• Quality of Life

Intervention

Behavioral:
• Benefit-finding Writing Activity
Caregivers will be instructed to write about the benefits of caring, considering things such as improved social relationship, appreciation of life and loved ones, and the positive consequences with respect to these.
• Neutral Writing Activity
The control group will be instructed to write number of things about the weather that day. Although the sentences can be as long or as short as they like, they will be encouraged to try and aim for about 3 or 4 sentences at least.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Limerick	Care Alliance Ireland, Carolan Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benefit Finding (Adapted version of the 17-item Benefit Finding Scale; Antoni et al., 2001)	Used to assess change in benefit-finding levels over the course of the intervention and follow-up	Baseline, immediate post-intervention (two weeks), and 3 months	No
Secondary	Caregiver Quality of Life (40 item Adult Carer Quality of Life Questionnaire; Joseph, Becker, Elwick, & Silburn, 2012)	This measures quality of life in eight separate domains: support for caring; caring choice; caring stress; money matters; personal growth; sense of value; ability to care; and carer satisfaction. Used to assess change in quality of life levels over the course of the intervention and follow-up	Baseline, immediate post-intervention (two weeks), and 3 months	No
Secondary	Psychological Distress (Hospital and Anxiety Depression Scale; Zigmond & Snaith, 1983)	Used to assess change in psychological distress levels over the course of the intervention and follow-up, and as a moderator	Baseline, immediate post-intervention (two weeks), and 3 months	No