NCT03077971

Brief Summary

This is a feasibility study to evaluate whether it is possible to conduct a larger study to evaluate whether providing psychological support to carers of people with MS is effective in reducing carer strain. Whilst not all carers experience distress as a result of their caring duties, some do. This study is testing the use of Acceptance and Commitment Therapy (ACT) in a self-help format. Participants will learn about and use ACT by reading a book provided to them by the study. One group will receive the ACT book, another will receive the same book alongside weekly telephone support to use the book, and a third group will act as a control group and therefore will not have extra support. Participants are allocated to the groups based on chance (a computer will decide group allocation). Participants will complete questionnaires before group allocation, and then again 3 months after they were allocated to a group, and one final time 6 months after group allocation. Those who receive the self-help book will get sent chapters each week for 8 weeks. The groups will be compared on scores from the questionnaires and complete feedback interviews with a subgroup of those who receive the book, to gain feedback about their experiences of the study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

February 28, 2017

Last Update Submit

November 23, 2017

Conditions

Carer Stress Syndrome

Keywords

Carers of People with Multiple SclerosisCarer StrainAcceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

  • ZBI

    Zarit Burden Interview as a measure of carer strain

    3 months

Secondary Outcomes (6)

  • ZBI

    6 months

  • MCSI

    3 months, 6 months

  • CAREQOL-MS

    3 months, 6 months

  • AAQ-II

    3 months, 6 months

  • CompACT

    3 months, 6 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Feedback Interviews

    3 months

Study Arms (3)

ACT Self-Help

EXPERIMENTAL

Participants in this arm will receive a self-help book based on Acceptance and Commitment Therapy (ACT). Participants will receive chapters each week, either electronically or by post, for 8 weeks.

Behavioral: ACT Self-Help

ACT Self-Help with Telephone Support

EXPERIMENTAL

Participants in this arm will receive a self-help book based on Acceptance and Commitment Therapy (ACT). Participants will receive chapters each week, either electronically or by post, for 8 weeks. In addition to this, participants will have weekly telephone calls to support the use of the book.

Behavioral: ACT Self-Help with Telephone Support

Treatment As Usual

NO INTERVENTION

Participants in this arm will have no intervention as part of the trial.

Interventions

ACT Self-HelpBEHAVIORAL

Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach

ACT Self-Help
ACT Self-Help with Telephone SupportBEHAVIORAL

Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls

ACT Self-Help with Telephone Support

Eligibility Criteria

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

You may qualify if:

  • primary carer for a person with MS,
  • English speaking (intervention and assessments are in English),
  • able to give informed consent.
  • score at least 21 on the Zarit Burden Interview (demonstrating a minimum of mild distress)

You may not qualify if:

  • diagnosis of MS themselves
  • psychiatric diagnosis
  • inability to commit to the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG81BB, United Kingdom

Location

Related Publications (1)

  • Potter KJ, Golijana-Moghaddam N, Evangelou N, Mhizha-Murira JR, das Nair R. Self-help Acceptance and Commitment Therapy for Carers of People with Multiple Sclerosis: A Feasibility Randomised Controlled Trial. J Clin Psychol Med Settings. 2021 Jun;28(2):279-294. doi: 10.1007/s10880-020-09711-x.

    PMID: 32144616DERIVED

Study Officials

  • Roshan dasNair

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 13, 2017

Study Start

December 1, 2016

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)