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

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ClinicalTrials.gov Identifier: NCT03077971
Recruitment Status : Unknown
Verified November 2017 by University of Nottingham.
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Carer Stress Syndrome Behavioral: ACT Self-Help Behavioral: ACT Self-Help with Telephone Support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis: A Feasibility Randomised Controlled Trial
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. ZBI [ Time Frame: 3 months ]
    Zarit Burden Interview as a measure of carer strain


Secondary Outcome Measures :
  1. ZBI [ Time Frame: 6 months ]
    Zarit Burden Interview as a measure of carer strain

  2. MCSI [ Time Frame: 3 months, 6 months ]
    Modified Carer Strain Index as a measure of carer strain

  3. CAREQOL-MS [ Time Frame: 3 months, 6 months ]
    CAREQOL- MS is a health-related quality of life scale designed for carers of people with MS

  4. AAQ-II [ Time Frame: 3 months, 6 months ]
    The Acceptance and Action Questionnaire is a measure of experiential avoidance and psychological inflexibility, consistent with the ACT model

  5. CompACT [ Time Frame: 3 months, 6 months ]
    The Comprehensive Assessment of Acceptance and Commitment Therapy measures important processes of ACT

  6. Service Use Questionnaire [ Time Frame: 3 months, 6 months ]
    The service use questionnaire will measure the frequency in which participants access health and social care services


Other Outcome Measures:
  1. Feedback Interviews [ Time Frame: 3 months ]
    A selection of those in the two intervention groups will be invited to complete an interview to give feedback about the intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077971


Locations
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United Kingdom
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG81BB
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Roshan dasNair University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03077971     History of Changes
Other Study ID Numbers: G14112016
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
Carers of People with Multiple Sclerosis
Carer Strain
Acceptance and Commitment Therapy
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases