Acceptance and Commitment Therapy for Muscle Disease

NCT02810028 | Completed DMC

• 1 other identifier: PB-PG-061331085
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Diseases

Keywords

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

Outcome Measures

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.

  9 weeks post randomisation

Secondary Outcomes (10)

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

  9 weeks post randomisation

• Work and Social Adjustment Scale (WSAS)

  9 weeks post randomisation

• Hospital Anxiety and Depression Scale (HADS)

  9 weeks post randomisation

• Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)

  9 weeks post randomisation

• Acceptance and Action Questionnaire (AAQ-II)

  9 weeks post randomisation

Other Outcomes (3)

• 6-minute timed walk test

  Baseline only

• Adult Ambulatory Neuromuscular Assessment (AANA)

  Baseline only

• Manual Muscle Strength Testing (MMST)

  Baseline only

Study Arms (2)

ACT + Standard Medical Care (SMC)

EXPERIMENTAL

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)

Standard Medical Care (SMC)

NO INTERVENTION

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

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

ACT + Standard Medical Care (SMC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator
• Barts & The London NHS Trust: collaborator
• Muscular Dystrophy Association: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator

Study Sites (1)

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

London, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 27176925 BACKGROUND

• 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.

  PMID: 27196863 BACKGROUND

• 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.

  PMID: 25297932 BACKGROUND

• 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.

  PMID: 22907225 BACKGROUND

• 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.

  PMID: 35192788 DERIVED

• 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.

  PMID: 30287669 DERIVED

MeSH Terms

Conditions

Muscular Dystrophies, Limb-Girdle; Muscular Dystrophy, Duchenne; Muscular Dystrophy, Facioscapulohumeral; Myositis, Inclusion Body

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Myositis

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael Rose

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• Trudie Chalder

  King's College London

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: January 1, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)