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Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis

Primary Purpose

Carer Stress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ACT Self-Help
ACT Self-Help with Telephone Support
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carer Stress Syndrome focused on measuring Carers of People with Multiple Sclerosis, Carer Strain, Acceptance and Commitment Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Sites / Locations

  • University of Nottingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

ACT Self-Help

ACT Self-Help with Telephone Support

Treatment As Usual

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

ZBI
Zarit Burden Interview as a measure of carer strain

Secondary Outcome Measures

ZBI
Zarit Burden Interview as a measure of carer strain
MCSI
Modified Carer Strain Index as a measure of carer strain
CAREQOL-MS
CAREQOL- MS is a health-related quality of life scale designed for carers of people with MS
AAQ-II
The Acceptance and Action Questionnaire is a measure of experiential avoidance and psychological inflexibility, consistent with the ACT model
CompACT
The Comprehensive Assessment of Acceptance and Commitment Therapy measures important processes of ACT
Service Use Questionnaire
The service use questionnaire will measure the frequency in which participants access health and social care services

Full Information

First Posted
February 28, 2017
Last Updated
November 23, 2017
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT03077971
Brief Title
Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis
Official Title
Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis: A Feasibility Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carer Stress Syndrome
Keywords
Carers of People with Multiple Sclerosis, Carer Strain, Acceptance and Commitment Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT Self-Help
Arm Type
Experimental
Arm Description
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.
Arm Title
ACT Self-Help with Telephone Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Participants in this arm will have no intervention as part of the trial.
Intervention Type
Behavioral
Intervention Name(s)
ACT Self-Help
Intervention Description
Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach
Intervention Type
Behavioral
Intervention Name(s)
ACT Self-Help with Telephone Support
Intervention Description
Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls
Primary Outcome Measure Information:
Title
ZBI
Description
Zarit Burden Interview as a measure of carer strain
Time Frame
3 months
Secondary Outcome Measure Information:
Title
ZBI
Description
Zarit Burden Interview as a measure of carer strain
Time Frame
6 months
Title
MCSI
Description
Modified Carer Strain Index as a measure of carer strain
Time Frame
3 months, 6 months
Title
CAREQOL-MS
Description
CAREQOL- MS is a health-related quality of life scale designed for carers of people with MS
Time Frame
3 months, 6 months
Title
AAQ-II
Description
The Acceptance and Action Questionnaire is a measure of experiential avoidance and psychological inflexibility, consistent with the ACT model
Time Frame
3 months, 6 months
Title
CompACT
Description
The Comprehensive Assessment of Acceptance and Commitment Therapy measures important processes of ACT
Time Frame
3 months, 6 months
Title
Service Use Questionnaire
Description
The service use questionnaire will measure the frequency in which participants access health and social care services
Time Frame
3 months, 6 months
Other Pre-specified Outcome Measures:
Title
Feedback Interviews
Description
A selection of those in the two intervention groups will be invited to complete an interview to give feedback about the intervention
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: diagnosis of MS themselves psychiatric diagnosis inability to commit to the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshan dasNair
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG81BB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32144616
Citation
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.
Results Reference
derived

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Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis

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