Acceptance and Commitment Therapy for Muscle Disease

Muscle Diseases Clinical Trial

— ACTMuS  

Official title:

Acceptance and Commitment Therapy for Muscle Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810028
• Other study ID #: PB-PG-061331085
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: January 2019

Study information

• Verified date: August 2019
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: January 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Diseases
• Muscular Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital; The Royal London Hospital; University Hospital Southampton; King's College London	London

Sponsors (5)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Barts & The London NHS Trust, King's College London, Muscular Dystrophy Association, University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View Citation

Graham CD, Gouick J, Krahé 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	6-minute timed walk test	Measures mobility.	Baseline only
Other	Adult Ambulatory Neuromuscular Assessment (AANA)	An adult version of the North Star Ambulatory Assessment that measures motor function.	Baseline only
Other	Manual Muscle Strength Testing (MMST)	Measures muscle strength.	Baseline only
Primary	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	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
Secondary	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
Secondary	Hospital Anxiety and Depression Scale (HADS)	Measures mood.	9 weeks post randomisation
Secondary	Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)	Measures functional impairment.	9 weeks post randomisation
Secondary	Acceptance and Action Questionnaire (AAQ-II)	Measures psychological flexibility.	9 weeks post randomisation
Secondary	Mindfulness Attention Awareness Scale (MAAS)	Measures dispositional open awareness of and attention to the present moment.	9 weeks post randomisation
Secondary	Committed Action Scale (CAS)	Measures commitment towards goals.	9 weeks post randomisation
Secondary	IBM Functional Rating Scale	Assesses function in people with Inclusion Body Myositis.	9 weeks post randomisation
Secondary	Patient Global Impression of Change scale (PGIC)	Assesses patient's own impression of change during the course of the study.	9 weeks post randomisation
Secondary	Patient rating of treatment satisfaction	Measures patient's satisfaction with the treatment they have received.	9 weeks post randomisation