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

Study Overview
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Brief Summary
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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.

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

Conditions
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Carer Stress Syndrome

Intervention / Treatment
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* Behavioral: ACT Self-Help
* Behavioral: ACT Self-Help with Telephone Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carers of People with Multiple Sclerosis, Carer Strain, Acceptance and Commitment Therapy