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

NCT ID: NCT03077971

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-06-30

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.

Detailed Description

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Conditions

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Carer Stress Syndrome

Keywords

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Carers of People with Multiple Sclerosis Carer Strain Acceptance and Commitment Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ACT Self-Help

Intervention Type BEHAVIORAL

Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach

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.

Group Type EXPERIMENTAL

ACT Self-Help with Telephone Support

Intervention Type BEHAVIORAL

Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls

Treatment As Usual

Participants in this arm will have no intervention as part of the trial.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ACT Self-Help

Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach

Intervention Type BEHAVIORAL

ACT Self-Help with Telephone Support

Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roshan dasNair

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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University of Nottingham

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 32144616 (View on PubMed)

Other Identifiers

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G14112016

Identifier Type: -

Identifier Source: org_study_id