Clinical trial NCT02810028: Acceptance and Commitment Therapy for Muscle Disease
Official title: Acceptance and Commitment Therapy for Muscle Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Diseases
Keywords: Limb girdle muscular dystrophy
Becker's muscular dystrophy
Facioscapulohumeral muscular dystrophy
Inclusion-body myositis
Acceptance and Commitment Therapy
ACT
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: King's College London
name: Barts & The London NHS Trust
name: Muscular Dystrophy Association
name: University Hospital Southampton NHS Foundation Trust
First posted: 2016-06-22
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Life areas
timeFrame: 9 weeks post randomisation
Secondary outcomes:
measure: Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Symptom impact domains
timeFrame: 9 weeks post randomisation
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 9 weeks post randomisation
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 9 weeks post randomisation
measure: Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: 9 weeks post randomisation
measure: Acceptance and Action Questionnaire (AAQ-II)
timeFrame: 9 weeks post randomisation
measure: Mindfulness Attention Awareness Scale (MAAS)
timeFrame: 9 weeks post randomisation
measure: Committed Action Scale (CAS)
timeFrame: 9 weeks post randomisation
measure: IBM Functional Rating Scale
timeFrame: 9 weeks post randomisation
measure: Patient Global Impression of Change scale (PGIC)
timeFrame: 9 weeks post randomisation
measure: Patient rating of treatment satisfaction
timeFrame: 9 weeks post randomisation
Other outcomes:
measure: 6-minute timed walk test
timeFrame: Baseline only
measure: Adult Ambulatory Neuromuscular Assessment (AANA)
timeFrame: Baseline only
measure: Manual Muscle Strength Testing (MMST)
timeFrame: Baseline only
Locations:
city: London
country: United Kingdom
facility: King's College Hospital; The Royal London Hospital; University Hospital Southampton; King's College London
Study officials:
affiliation: King's College Hospital NHS Trust
name: Michael Rose
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Trudie Chalder
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Lance McCracken
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leeds
name: Christopher Graham
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Sam Norton
role: PRINCIPAL_INVESTIGATOR
affiliation: Barts & The London NHS Trust
name: Aleksandar Radunovic
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.