Quality of LifeBRiCNCT02444312
Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study
A study testing Benefit-finding Writing Activity and Neutral Writing Activity in people with Quality of Life and Psychological Distress, run by University of Limerick.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Psychological Distress
- What is being tested?
- Benefit-finding Writing Activity and Neutral Writing Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be over the age of 18
- Must identify as caring for a family member, friend or relative
- Must be living in Ireland
Who cannot join
- If the person cared for is living in institutional care
About this study
Official title: A Randomised Controlled Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study Protocol
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.
Read the 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.
- Conditions
- Quality of Life, Psychological Distress
- Being tested
- Benefit-finding Writing Activity, Neutral Writing Activity
- Keywords
- Caregiving, Benefit Finding, Writing Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benefit-finding Writing ActivityBehavioural
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 ActivityBehavioural
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 group | Role | What they receive |
|---|---|---|
| Benefit-finding Writing Activity | Experimental | 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. Receives: Behavioral: Benefit-finding Writing Activity |
| Neutral Writing activity | Active comparator | For two weeks, on six days of their choice, caregivers will be instructed to write about a neutral topic. Receives: Behavioral: Neutral Writing Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, immediate post-intervention (two weeks), and 3 months
Secondary outcomes (2)
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
Measured: Baseline, immediate post-intervention (two weeks), and 3 months
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
Measured: Baseline, immediate post-intervention (two weeks), and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- Carolan Research Institute, Care Alliance Ireland
- Responsible party
- Principal investigator, Brenda O'Connell, University of Limerick
- Investigators
- Stephen Gallagher, PhD, Study director, University of Limerick, Department of PsychologyCharles Brand, MSc, Principal investigator, University of LimerickBrenda H O' Connell, B.A, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444312
- Sponsor's protocol ID
- BRiC2015
- Acronym
- BRiC
- Status last verified
- Oct 2015
- First submitted
- 11 May 2015
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study Protocol
- ClinicalTrials.gov ID
- NCT02444312
- Acronym / sponsor ID
- BRiC / BRiC2015
- Conditions
- Quality of Life, Psychological Distress
- Keywords
- Caregiving, Benefit Finding, Writing Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- Carolan Research Institute, Care Alliance Ireland
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benefit-finding Writing Activity | Experimental | Behavioral: Benefit-finding Writing ActivityFor 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. |
| Neutral Writing activity | Active comparator | Behavioral: Neutral Writing ActivityFor two weeks, on six days of their choice, caregivers will be instructed to write about a neutral topic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be over the age of 18
- Must identify as caring for a family member, friend or relative
- Must be living in Ireland
Key exclusion criteria (1 listed)
- If the person cared for is living in institutional care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benefit-finding Writing ActivityCaregivers 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. | Behavioural | Benefit-finding Writing Activity |
| Neutral Writing ActivityThe 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. | Behavioural | Neutral Writing activity |
Primary outcome
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
2 secondary outcomes
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
Psychological Distress (Hospital and Anxiety Depression Scale; Zigmond & Snaith, 1983)
Time frame: Baseline, immediate post-intervention (two weeks), and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Gallagher, PhD study director
University of Limerick, Department of Psychology
Charles Brand, MSc principal investigator
University of Limerick
Brenda H O' Connell, B.A principal investigator
University of Limerick
Questions about this trial
What is this clinical trial studying?
A study testing Benefit-finding Writing Activity and Neutral Writing Activity in people with Quality of Life and Psychological Distress, run by University of Limerick.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.