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

Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis: A Feasibility Randomised Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Carer Stress Syndrome
• Intervention / Treatment: Behavioral: ACT Self-Help; Behavioral: ACT Self-Help with Telephone Support

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG81BB
      • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT Self-Help; 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; Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach
Experimental: ACT Self-Help with Telephone Support; 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; Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls
No Intervention: Treatment As Usual; Participants in this arm will have no intervention as part of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ZBI	Zarit Burden Interview as a measure of carer strain	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ZBI	Zarit Burden Interview as a measure of carer strain	6 months
MCSI	Modified Carer Strain Index as a measure of carer strain	3 months, 6 months
CAREQOL-MS	CAREQOL- MS is a health-related quality of life scale designed for carers of people with MS	3 months, 6 months
AAQ-II	The Acceptance and Action Questionnaire is a measure of experiential avoidance and psychological inflexibility, consistent with the ACT model	3 months, 6 months
CompACT	The Comprehensive Assessment of Acceptance and Commitment Therapy measures important processes of ACT	3 months, 6 months
Service Use Questionnaire	The service use questionnaire will measure the frequency in which participants access health and social care services	3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feedback Interviews	A selection of those in the two intervention groups will be invited to complete an interview to give feedback about the intervention	3 months

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Roshan dasNair, University of Nottingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Carers of People with Multiple Sclerosis; Carer Strain; Acceptance and Commitment Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: G14112016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No