NCT02444312

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable quality-of-life

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

May 11, 2015

Last Update Submit

October 5, 2015

Conditions

Keywords

CaregivingBenefit FindingWriting Intervention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Caregiver Quality of Life (40 item Adult Carer Quality of Life Questionnaire; Joseph, Becker, Elwick, & Silburn, 2012)

    Baseline, immediate post-intervention (two weeks), and 3 months

  • Psychological Distress (Hospital and Anxiety Depression Scale; Zigmond & Snaith, 1983)

    Baseline, immediate post-intervention (two weeks), and 3 months

Study Arms (2)

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.

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.

Behavioral: Neutral Writing Activity

Interventions

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.

Benefit-finding 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.

Neutral Writing activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be over the age of 18
  • Must identify as caring for a family member, friend or relative
  • Must be living in Ireland

You may not qualify if:

  • If the person cared for is living in institutional care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Stephen Gallagher, PhD

    University of Limerick, Department of Psychology

    STUDY DIRECTOR
  • Charles Brand, MSc

    University of Limerick

    PRINCIPAL INVESTIGATOR
  • Brenda H O' Connell, B.A

    University of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms. Brenda O'Connell

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 14, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 6, 2015

Record last verified: 2015-10