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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

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date November 27, 2017
Actual Study Start Date  ICMJE December 1, 2016
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
ZBI [ Time Frame: 3 months ]
Zarit Burden Interview as a measure of carer strain
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03077971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • ZBI [ Time Frame: 6 months ]
    Zarit Burden Interview as a measure of carer strain
  • MCSI [ Time Frame: 3 months, 6 months ]
    Modified Carer Strain Index as a measure of carer strain
  • 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
  • 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
  • CompACT [ Time Frame: 3 months, 6 months ]
    The Comprehensive Assessment of Acceptance and Commitment Therapy measures important processes of ACT
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 7, 2017)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis
Official Title  ICMJE Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis: A Feasibility Randomised Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Carer Stress Syndrome
Intervention  ICMJE
  • Behavioral: ACT Self-Help
    Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach
  • Behavioral: ACT Self-Help with Telephone Support
    Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: ACT Self-Help
  • 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.
    Intervention: Behavioral: ACT Self-Help with Telephone Support
  • No Intervention: Treatment As Usual
    Participants in this arm will have no intervention as part of the trial.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 23, 2017)
24
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2017)
54
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077971
Other Study ID Numbers  ICMJE G14112016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roshan dasNair University of Nottingham
PRS Account University of Nottingham
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP