Muscle DiseasesACTMuSNCT02810028
Acceptance and Commitment Therapy for Muscle Disease
A study testing Acceptance and Commitment Therapy (ACT) in people with Muscle Diseases, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Diseases
- What is being tested?
- Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Inclusion body myositis clinic-pathologically defined, clinically defined or probable IBM based on ENMC research diagnostic criteria 2013 (submitted)
- duration of muscle disease greater than six months
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital; The Royal London Hospital; University Hospital Southampton; King's College London
London
About this study
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.
- Conditions
- Muscle Diseases
- Being tested
- Acceptance and Commitment Therapy (ACT)
- Keywords
- Limb girdle muscular dystrophy, Becker's muscular dystrophy, Facioscapulohumeral muscular dystrophy, Inclusion-body myositis, Acceptance and Commitment Therapy, ACT
- Medical subject headings
- Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, Muscular Dystrophy, Facioscapulohumeral, Myositis, Inclusion Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 weeks post randomisation
Secondary outcomes (10)
Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Symptom impact domains
Measures the impact of key muscle disease symptoms: weakness, fatigue and pain.
Measured: 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.
Measured: 9 weeks post randomisation
Hospital Anxiety and Depression Scale (HADS)
Measures mood.
Measured: 9 weeks post randomisation
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)
Measures functional impairment.
Measured: 9 weeks post randomisation
Acceptance and Action Questionnaire (AAQ-II)
Measures psychological flexibility.
Measured: 9 weeks post randomisation
Mindfulness Attention Awareness Scale (MAAS)
Measures dispositional open awareness of and attention to the present moment.
Measured: 9 weeks post randomisation
Committed Action Scale (CAS)
Measures commitment towards goals.
Measured: 9 weeks post randomisation
IBM Functional Rating Scale
Assesses function in people with Inclusion Body Myositis.
Measured: 9 weeks post randomisation
Patient Global Impression of Change scale (PGIC)
Assesses patient's own impression of change during the course of the study.
Measured: 9 weeks post randomisation
Patient rating of treatment satisfaction
Measures patient's satisfaction with the treatment they have received.
Measured: 9 weeks post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Barts & The London NHS Trust, Muscular Dystrophy Association, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Michael Rose, Principal investigator, King's College Hospital NHS TrustTrudie Chalder, Principal investigator, King's College LondonLance McCracken, Principal investigator, King's College LondonChristopher Graham, Principal investigator, University of LeedsSam Norton, Principal investigator, King's College LondonAleksandar Radunovic, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810028
- Sponsor's protocol ID
- PB-PG-061331085
- Acronym
- ACTMuS
- Status last verified
- Aug 2019
- First submitted
- 20 Jun 2016
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 27176925Graham 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 27196863Graham 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 25297932Rose 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 22907225Rose 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 35192788Rose 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Muscle Disease
- ClinicalTrials.gov ID
- NCT02810028
- Acronym / sponsor ID
- ACTMuS / PB-PG-061331085
- Conditions
- Muscle Diseases
- Keywords
- Limb girdle muscular dystrophy, Becker's muscular dystrophy, Facioscapulohumeral muscular dystrophy, Inclusion-body myositis, Acceptance and Commitment Therapy, ACT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London, Barts & The London NHS Trust, Muscular Dystrophy Association, University Hospital Southampton NHS Foundation Trust
- Study start
- Jul 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT + Standard Medical Care (SMC) | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with one of four specific muscle diseases on the basis of diagnostic criteria:
- 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
Key exclusion criteria (9 listed)
- Major active co-morbidities unrelated to muscle disease such as arthritis, respiratory disease, cardiovascular disease
- Unstable complications of muscle disease including:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ACT + Standard Medical Care (SMC) |
Primary outcome
Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Life areas
Time frame: 9 weeks post randomisation
Measures impact of MD on life areas: activities, independence, social functioning, emotional functioning and body image.
10 secondary outcomes
Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Symptom impact domains
Time frame: 9 weeks post randomisation
Work and Social Adjustment Scale (WSAS)
Time frame: 9 weeks post randomisation
Hospital Anxiety and Depression Scale (HADS)
Time frame: 9 weeks post randomisation
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: 9 weeks post randomisation
Acceptance and Action Questionnaire (AAQ-II)
Time frame: 9 weeks post randomisation
Mindfulness Attention Awareness Scale (MAAS)
Time frame: 9 weeks post randomisation
Committed Action Scale (CAS)
Time frame: 9 weeks post randomisation
IBM Functional Rating Scale
Time frame: 9 weeks post randomisation
Patient Global Impression of Change scale (PGIC)
Time frame: 9 weeks post randomisation
Patient rating of treatment satisfaction
Time frame: 9 weeks post randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Background: PubMed 27176925Graham 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.
- Background: PubMed 27196863Graham 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.
- Background: PubMed 25297932Graham 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.
- Background: PubMed 22907225Rose 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.
- Derived from this study: PubMed 35192788Rose 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.
- Derived from this study: PubMed 30287669Rose 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) in people with Muscle Diseases, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Life areas (time frame: 9 weeks post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810028, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.