Acceptance and Commitment Therapy for Muscle Disease (ACTMuS)

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.

Study Overview

• Status: Completed
• Conditions: Muscle Diseases
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT)

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ACT + Standard Medical Care (SMC); 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.	Behavioral: Acceptance and Commitment Therapy (ACT); 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.
NO_INTERVENTION: Standard Medical Care (SMC); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 weeks post randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Symptom impact domains	Measures the impact of key muscle disease symptoms: weakness, fatigue and pain.	9 weeks post randomisation
Work and Social Adjustment Scale (WSAS)	Assesses how much symptoms interfere with participation in life i.e. work, home management, social, private and relationships.	9 weeks post randomisation
Hospital Anxiety and Depression Scale (HADS)	Measures mood.	9 weeks post randomisation
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)	Measures functional impairment.	9 weeks post randomisation
Acceptance and Action Questionnaire (AAQ-II)	Measures psychological flexibility.	9 weeks post randomisation
Mindfulness Attention Awareness Scale (MAAS)	Measures dispositional open awareness of and attention to the present moment.	9 weeks post randomisation
Committed Action Scale (CAS)	Measures commitment towards goals.	9 weeks post randomisation
IBM Functional Rating Scale	Assesses function in people with Inclusion Body Myositis.	9 weeks post randomisation
Patient Global Impression of Change scale (PGIC)	Assesses patient's own impression of change during the course of the study.	9 weeks post randomisation
Patient rating of treatment satisfaction	Measures patient's satisfaction with the treatment they have received.	9 weeks post randomisation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute timed walk test	Measures mobility.	Baseline only
Adult Ambulatory Neuromuscular Assessment (AANA)	An adult version of the North Star Ambulatory Assessment that measures motor function.	Baseline only
Manual Muscle Strength Testing (MMST)	Measures muscle strength.	Baseline only

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: King's College London; Barts & The London NHS Trust; University Hospital Southampton NHS Foundation Trust; Muscular Dystrophy Association
• Investigators: Principal Investigator: Michael Rose, King's College Hospital NHS Trust; Principal Investigator: Lance McCracken, King's College London; Principal Investigator: Christopher Graham, University of Leeds; Principal Investigator: Sam Norton, King's College London; Principal Investigator: Aleksandar Radunovic, Barts & The London NHS Trust

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. 2022 Feb 23:1-14. doi: 10.1017/S0033291722000083. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (ESTIMATE): June 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; ACT; Facioscapulohumeral muscular dystrophy; Limb girdle muscular dystrophy; Becker's muscular dystrophy; Inclusion-body myositis
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases
• Other Study ID Numbers: PB-PG-061331085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO