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

Carer Stress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03077971
• Other study ID #: G14112016
• Status: Active, not recruiting
• Phase: N/A
• First received: February 28, 2017
• Last updated: November 23, 2017
• Start date: December 1, 2016
• Est. completion date: June 2018

Study information

• Verified date: November 2017
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carer Stress Syndrome
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• ACT Self-Help
Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach
• ACT Self-Help with Telephone Support
Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	ZBI	Zarit Burden Interview as a measure of carer strain	3 months
Secondary	ZBI	Zarit Burden Interview as a measure of carer strain	6 months
Secondary	MCSI	Modified Carer Strain Index as a measure of carer strain	3 months, 6 months
Secondary	CAREQOL-MS	CAREQOL- MS is a health-related quality of life scale designed for carers of people with MS	3 months, 6 months
Secondary	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
Secondary	CompACT	The Comprehensive Assessment of Acceptance and Commitment Therapy measures important processes of ACT	3 months, 6 months
Secondary	Service Use Questionnaire	The service use questionnaire will measure the frequency in which participants access health and social care services	3 months, 6 months