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

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ClinicalTrials.gov Identifier: NCT02444312
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : October 6, 2015
Sponsor:
Collaborators:
Carolan Research Institute
Care Alliance Ireland
Information provided by (Responsible Party):
Brenda O'Connell, University of Limerick

Tracking Information
First Submitted Date  ICMJE May 11, 2015
First Posted Date  ICMJE May 14, 2015
Last Update Posted Date October 6, 2015
Study Start Date  ICMJE June 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
Benefit Finding (Adapted version of the 17-item Benefit Finding Scale; Antoni et al., 2001) [ Time Frame: Baseline, immediate post-intervention (two weeks), and 3 months ]
Used to assess change in benefit-finding levels over the course of the intervention and follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
  • Caregiver Quality of Life (40 item Adult Carer Quality of Life Questionnaire; Joseph, Becker, Elwick, & Silburn, 2012) [ Time Frame: Baseline, immediate post-intervention (two weeks), and 3 months ]
    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
  • Psychological Distress (Hospital and Anxiety Depression Scale; Zigmond & Snaith, 1983) [ Time Frame: Baseline, immediate post-intervention (two weeks), and 3 months ]
    Used to assess change in psychological distress levels over the course of the intervention and follow-up, and as a moderator
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study
Official Title  ICMJE A Randomised Controlled Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study Protocol
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Quality of Life
  • Psychological Distress
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Benefit-finding Writing Activity
    For two weeks, on six days of their choice, caregivers will be instructed to write about their thoughts and feelings in a diary/ notebook about the benefits of caring.
    Intervention: Behavioral: Benefit-finding Writing Activity
  • Active Comparator: Neutral Writing activity
    For two weeks, on six days of their choice, caregivers will be instructed to write about a neutral topic.
    Intervention: Behavioral: Neutral Writing Activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2015)
88
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2015)
96
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02444312
Other Study ID Numbers  ICMJE BRiC2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Brenda O'Connell, University of Limerick
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Limerick
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Carolan Research Institute
  • Care Alliance Ireland
Investigators  ICMJE
Study Director: Stephen Gallagher, PhD University of Limerick, Department of Psychology
Principal Investigator: Charles Brand, MSc University of Limerick
Principal Investigator: Brenda H O' Connell, B.A University of Limerick
PRS Account University of Limerick
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP