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Acceptance and Commitment Therapy for Muscle Disease (ACTMuS)

Primary Purpose

Muscle Diseases

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy (ACT)
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Diseases focused on measuring Limb girdle muscular dystrophy, Becker's muscular dystrophy, Facioscapulohumeral muscular dystrophy, Inclusion-body myositis, Acceptance and Commitment Therapy, ACT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with one of four specific muscle diseases on the basis of diagnostic criteria:

    1. Limb girdle muscular dystrophy; symptomatic limb girdle muscular dystrophy genetically or pathologically proven
    2. Dystrophinopathies resulting in a Becker' muscular dystrophy phenotype (excluding Duchenne muscular dystrophy) with pathology or genetic diagnosis
    3. Facioscapulohumeral muscular dystrophy diagnosed clinically with specific genetic abnormality in the subject or their family
    4. Inclusion body myositis clinic-pathologically defined, clinically defined or probable IBM based on ENMC research diagnostic criteria 2013 (submitted)
  2. duration of muscle disease greater than six months
  3. over the age of 18 years
  4. access to the internet and a computer on which they can receive the intervention materials
  5. HADS scores > 8 for depression or >8 for anxiety

Exclusion Criteria:

  1. Major active co-morbidities unrelated to muscle disease such as arthritis, respiratory disease, cardiovascular disease

  2. Unstable complications of muscle disease including:

    1. neuromuscular respiratory weakness
    2. cardiomyopathy
  3. Cognitive impairment that prevents comprehension of the questionnaires; assessed using the Montreal Cognitive Assessment
  4. Unable to read English questionnaires
  5. Major diagnosed active mental health co-morbidities e.g. psychosis, major depression, obsessive compulsive disorder, active suicide risk
  6. Current or recent participation in other treatment intervention studies (< 4 weeks after completion)
  7. Currently receiving psychological support or psychotherapy

Sites / Locations

  • King's College Hospital; The Royal London Hospital; University Hospital Southampton; King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ACT + Standard Medical Care (SMC)

Standard Medical Care (SMC)

Arm Description

This consists of 4 self-guided psycho-education modules supported by weekly telephone contact with a health professional trained in Acceptance and Commitment Therapy (ACT). Standard medical care will be provided as usual.

All participants will receive SMC. As such, they will receive all the treatment and support they would otherwise receive outside of a research trial including a personalised assessment from the physiotherapist.

Outcomes

Primary Outcome Measures

Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Life areas
Measures impact of MD on life areas: activities, independence, social functioning, emotional functioning and body image.

Secondary Outcome Measures

Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Symptom impact domains
Measures the impact of key muscle disease symptoms: weakness, fatigue and pain.
Work and Social Adjustment Scale (WSAS)
Assesses how much symptoms interfere with participation in life i.e. work, home management, social, private and relationships.
Hospital Anxiety and Depression Scale (HADS)
Measures mood.
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)
Measures functional impairment.
Acceptance and Action Questionnaire (AAQ-II)
Measures psychological flexibility.
Mindfulness Attention Awareness Scale (MAAS)
Measures dispositional open awareness of and attention to the present moment.
Committed Action Scale (CAS)
Measures commitment towards goals.
IBM Functional Rating Scale
Assesses function in people with Inclusion Body Myositis.
Patient Global Impression of Change scale (PGIC)
Assesses patient's own impression of change during the course of the study.
Patient rating of treatment satisfaction
Measures patient's satisfaction with the treatment they have received.

Full Information

First Posted
June 20, 2016
Last Updated
August 20, 2019
Sponsor
King's College Hospital NHS Trust
Collaborators
King's College London, Barts & The London NHS Trust, Muscular Dystrophy Association, University Hospital Southampton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02810028
Brief Title
Acceptance and Commitment Therapy for Muscle Disease
Acronym
ACTMuS
Official Title
Acceptance and Commitment Therapy for Muscle Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
King's College London, Barts & The London NHS Trust, Muscular Dystrophy Association, University Hospital Southampton NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In adults, muscle diseases are usually chronic long-term conditions that do not have a definitive cure. Supportive care has been shown to reduce complications from muscle disease and improved survival in some cases. However, there has been limited research to evaluate interventions that may improve quality of life (QoL) with this patient group. The QoL of those with MD is not just affected by the severity of their MD but also a variety of psychological variables. Based upon the knowledge of these psychological variables the investigators feel that a particular type of psychological intervention known as "acceptance and commitment therapy" (ACT) could potentially improve QoL in those with MD. The investigators therefore propose to test whether ACT does in fact improve QoL in those with MD by randomising 154 patients to receive either standard medical care plus a guided self-help ACT programme, or standard medical care only.
Detailed Description
Previous research has shown that while QoL is determined by the severity of the MD, this does not explain all aspects of the reduced QoL of those with MD. Previous research suggested that a cognitive behavioural approach using Acceptance and Commitment Therapy (ACT) would best suit those with MD. A pilot study of this approach in seven participants with MD was promising, and has led to this definitive trial of ACT. The aim of this study is to determine the efficacy of an ACT intervention to improve the QoL of individuals with MD. Patients with one of the following muscle diseases will be recruited: limb girdle muscular dystrophy, dystrophinopathies resulting in a Becker' muscular dystrophy phenotype, facioscapulohumeral muscular dystrophy and inclusion body myositis. Patients will be recruited primarily through muscle clinics at King's College Hospital (KCH) and The Royal London Hospital (RLH) but also via Muscular Dystrophy UK (MDUK) and UK registries of patients with these muscle diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Diseases
Keywords
Limb girdle muscular dystrophy, Becker's muscular dystrophy, Facioscapulohumeral muscular dystrophy, Inclusion-body myositis, Acceptance and Commitment Therapy, ACT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT + Standard Medical Care (SMC)
Arm Type
Experimental
Arm Description
This consists of 4 self-guided psycho-education modules supported by weekly telephone contact with a health professional trained in Acceptance and Commitment Therapy (ACT). Standard medical care will be provided as usual.
Arm Title
Standard Medical Care (SMC)
Arm Type
No Intervention
Arm Description
All participants will receive SMC. As such, they will receive all the treatment and support they would otherwise receive outside of a research trial including a personalised assessment from the physiotherapist.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT)
Intervention Description
Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy focused explicitly on promoting psychological flexibility. An ACT programme suits the aims of the study because it targets avoidance of distress, promotes acceptance of illness through motivating meaningful activity outside of illness, improves the processes that underlie beliefs rather than by directly challenging beliefs, thus reducing possible trivialisation of the understandable distress caused by living with MD.
Primary Outcome Measure Information:
Title
Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Life areas
Description
Measures impact of MD on life areas: activities, independence, social functioning, emotional functioning and body image.
Time Frame
9 weeks post randomisation
Secondary Outcome Measure Information:
Title
Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Symptom impact domains
Description
Measures the impact of key muscle disease symptoms: weakness, fatigue and pain.
Time Frame
9 weeks post randomisation
Title
Work and Social Adjustment Scale (WSAS)
Description
Assesses how much symptoms interfere with participation in life i.e. work, home management, social, private and relationships.
Time Frame
9 weeks post randomisation
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Measures mood.
Time Frame
9 weeks post randomisation
Title
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)
Description
Measures functional impairment.
Time Frame
9 weeks post randomisation
Title
Acceptance and Action Questionnaire (AAQ-II)
Description
Measures psychological flexibility.
Time Frame
9 weeks post randomisation
Title
Mindfulness Attention Awareness Scale (MAAS)
Description
Measures dispositional open awareness of and attention to the present moment.
Time Frame
9 weeks post randomisation
Title
Committed Action Scale (CAS)
Description
Measures commitment towards goals.
Time Frame
9 weeks post randomisation
Title
IBM Functional Rating Scale
Description
Assesses function in people with Inclusion Body Myositis.
Time Frame
9 weeks post randomisation
Title
Patient Global Impression of Change scale (PGIC)
Description
Assesses patient's own impression of change during the course of the study.
Time Frame
9 weeks post randomisation
Title
Patient rating of treatment satisfaction
Description
Measures patient's satisfaction with the treatment they have received.
Time Frame
9 weeks post randomisation
Other Pre-specified Outcome Measures:
Title
6-minute timed walk test
Description
Measures mobility.
Time Frame
Baseline only
Title
Adult Ambulatory Neuromuscular Assessment (AANA)
Description
An adult version of the North Star Ambulatory Assessment that measures motor function.
Time Frame
Baseline only
Title
Manual Muscle Strength Testing (MMST)
Description
Measures muscle strength.
Time Frame
Baseline only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with one of four specific muscle diseases on the basis of diagnostic criteria: Limb girdle muscular dystrophy; symptomatic limb girdle muscular dystrophy genetically or pathologically proven Dystrophinopathies resulting in a Becker' muscular dystrophy phenotype (excluding Duchenne muscular dystrophy) with pathology or genetic diagnosis Facioscapulohumeral muscular dystrophy diagnosed clinically with specific genetic abnormality in the subject or their family Inclusion body myositis clinic-pathologically defined, clinically defined or probable IBM based on ENMC research diagnostic criteria 2013 (submitted) duration of muscle disease greater than six months over the age of 18 years access to the internet and a computer on which they can receive the intervention materials HADS scores > 8 for depression or >8 for anxiety Exclusion Criteria: Major active co-morbidities unrelated to muscle disease such as arthritis, respiratory disease, cardiovascular disease Unstable complications of muscle disease including: neuromuscular respiratory weakness cardiomyopathy Cognitive impairment that prevents comprehension of the questionnaires; assessed using the Montreal Cognitive Assessment Unable to read English questionnaires Major diagnosed active mental health co-morbidities e.g. psychosis, major depression, obsessive compulsive disorder, active suicide risk Current or recent participation in other treatment intervention studies (< 4 weeks after completion) Currently receiving psychological support or psychotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rose
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trudie Chalder
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lance McCracken
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Graham
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sam Norton
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aleksandar Radunovic
Organizational Affiliation
Barts & The London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital; The Royal London Hospital; University Hospital Southampton; King's College London
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27176925
Citation
Graham CD, Gouick J, Krahe C, Gillanders D. A systematic review of the use of Acceptance and Commitment Therapy (ACT) in chronic disease and long-term conditions. Clin Psychol Rev. 2016 Jun;46:46-58. doi: 10.1016/j.cpr.2016.04.009. Epub 2016 Apr 20.
Results Reference
background
PubMed Identifier
27196863
Citation
Graham CD, Gouick J, Ferreira N, Gillanders D. The influence of psychological flexibility on life satisfaction and mood in muscle disorders. Rehabil Psychol. 2016 May;61(2):210-7. doi: 10.1037/rep0000092.
Results Reference
background
PubMed Identifier
25297932
Citation
Graham CD, Simmons Z, Stuart SR, Rose MR. The potential of psychological interventions to improve quality of life and mood in muscle disorders. Muscle Nerve. 2015 Jul;52(1):131-6. doi: 10.1002/mus.24487. Epub 2015 May 28.
Results Reference
background
PubMed Identifier
22907225
Citation
Rose MR, Sadjadi R, Weinman J, Akhtar T, Pandya S, Kissel JT, Jackson CE; Muscle Study Group. Role of disease severity, illness perceptions, and mood on quality of life in muscle disease. Muscle Nerve. 2012 Sep;46(3):351-9. doi: 10.1002/mus.23320.
Results Reference
background
PubMed Identifier
35192788
Citation
Rose M, Graham CD, O'Connell N, Vari C, Edwards V, Taylor E, McCracken LM, Radunovic A, Rakowicz W, Norton S, Chalder T. A randomised controlled trial of acceptance and commitment therapy for improving quality of life in people with muscle diseases. Psychol Med. 2023 Jun;53(8):3511-3524. doi: 10.1017/S0033291722000083. Epub 2022 Feb 23.
Results Reference
derived
PubMed Identifier
30287669
Citation
Rose MR, Norton S, Vari C, Edwards V, McCracken L, Graham CD, Radunovic A, Chalder T. Acceptance and Commitment Therapy for Muscle Disease (ACTMus): protocol for a two-arm randomised controlled trial of a brief guided self-help ACT programme for improving quality of life in people with muscle diseases. BMJ Open. 2018 Oct 3;8(10):e022083. doi: 10.1136/bmjopen-2018-022083.
Results Reference
derived

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Acceptance and Commitment Therapy for Muscle Disease

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