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CompletedNCT02810028ACTMuSUpdated Aug 22, 2019

Acceptance and Commitment Therapy for Muscle Disease

An interventional study of Acceptance and Commitment Therapy (ACT) in Muscle Diseases, sponsored by King's College Hospital NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-22.

Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
155
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Muscle Diseases

Keywords

  • Limb girdle muscular dystrophy
  • Becker's muscular dystrophy
  • Facioscapulohumeral muscular dystrophy
  • Inclusion-body myositis
  • Acceptance and Commitment Therapy
  • ACT
03

In context

Muscular Dystrophies, Limb-Girdle

55 studies on the registry are indexed under Muscular Dystrophies, Limb-Girdle; 10 are open to participants now.

This study's enrollment of 155 is above the median of 15 across 24 interventional studies indexed under Muscular Dystrophies, Limb-Girdle.

Browse Muscular Dystrophies, Limb-Girdle studies →

Lead sponsor

King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.

Browse King's College Hospital NHS Trust studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
155 participants (actual)

Study arms

  • 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)

  • 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.

Interventions

  • BehavioralAcceptance 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 weeks post randomisation

Secondary outcomes

  1. Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Symptom impact domains

    Measures the impact of key muscle disease symptoms: weakness, fatigue and pain.

    Time frame: 9 weeks post randomisation

  2. Work and Social Adjustment Scale (WSAS)

    Assesses how much symptoms interfere with participation in life i.e. work, home management, social, private and relationships.

    Time frame: 9 weeks post randomisation

  3. Hospital Anxiety and Depression Scale (HADS)

    Measures mood.

    Time frame: 9 weeks post randomisation

  4. Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)

    Measures functional impairment.

    Time frame: 9 weeks post randomisation

  5. Acceptance and Action Questionnaire (AAQ-II)

    Measures psychological flexibility.

    Time frame: 9 weeks post randomisation

  6. Mindfulness Attention Awareness Scale (MAAS)

    Measures dispositional open awareness of and attention to the present moment.

    Time frame: 9 weeks post randomisation

  7. Committed Action Scale (CAS)

    Measures commitment towards goals.

    Time frame: 9 weeks post randomisation

  8. IBM Functional Rating Scale

    Assesses function in people with Inclusion Body Myositis.

    Time frame: 9 weeks post randomisation

  9. Patient Global Impression of Change scale (PGIC)

    Assesses patient's own impression of change during the course of the study.

    Time frame: 9 weeks post randomisation

  10. Patient rating of treatment satisfaction

    Measures patient's satisfaction with the treatment they have received.

    Time frame: 9 weeks post randomisation

Other outcomes

  1. 6-minute timed walk test

    Measures mobility.

    Time frame: Baseline only

  2. Adult Ambulatory Neuromuscular Assessment (AANA)

    An adult version of the North Star Ambulatory Assessment that measures motor function.

    Time frame: Baseline only

  3. Manual Muscle Strength Testing (MMST)

    Measures muscle strength.

    Time frame: Baseline only

07

Study locations

1 site
  • King's College Hospital; The Royal London Hospital; University Hospital Southampton; King's College London
    London, United Kingdom
08

References and documents

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. PubMed 27176925 ↗
  • 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. PubMed 27196863 ↗
  • 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. PubMed 25297932 ↗
  • 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. PubMed 22907225 ↗
  • 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. PubMed 35192788 ↗
  • 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. PubMed 30287669 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02810028
Lead 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
Responsible party
Sponsor
First posted
Jun 22, 2016
Start date
Jul 2016
Primary completion
Apr 2018
Completion
Jan 2019
Last update
Aug 22, 2019

Study contacts

Michael Rose
principal investigator · King's College Hospital NHS Trust
Trudie Chalder
principal investigator · King's College London
Lance McCracken
principal investigator · King's College London
Christopher Graham
principal investigator · University of Leeds
Sam Norton
principal investigator · King's College London
Aleksandar Radunovic
principal investigator · Barts & The London NHS Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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