Plain English Summary
http://www.southampton.ac.uk/samstrial/trial/about_the_trial1.html
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHM MED 0726
Study information
Scientific title
Acronym
saMS (Supportive Adjustment for Multiple Sclerosis)
Study hypothesis
Multiple sclerosis (MS) is a chronic progressive degenerative neurological disease affecting around 1 in 1,000 people in the UK. Although rarely fatal, MS produces a range of unpleasant and disabling symptoms. The course of MS is idiosyncratic and unpredictable and although the majority of patients experience a relapsing-remitting form of the illness, ultimately most patients experience a transition towards persistent disability. The nature and presentation of MS poses multiple psychosocial challenges. Individuals are faced with uncertainty about the future, unpleasant and unpredictable symptoms, treatment regimes and drug side effects. Since MS can have profound consequences including disruptions to life goals, employment, income, relationships, social and leisure activities and daily activities, it is unsurprising that it poses challenges for psychological adjustment.
The purpose of this study is to develop and test an intervention based upon the principals of cognitive behavioural therapy (CBT) to assist people in the early stages of MS to adjust to living with the disease.
The study aims to:
1. Develop a CBT manualised programme for adjusting to MS that can be delivered by general nurses receiving basic training in CBT and regular supervision
2. Determine whether patients with early stage MS who undertake a CBT course for adjustment to MS will demonstrate significantly greater reductions in key adjustment outcomes (less distress, and improvements in work and social adjustment) than those assigned to a Supportive Listening comparison condition
3. Examine the changes in beliefs, cognitions and behaviours in the two treatment groups and determine whether changes in these variables mediate improvements in distress and work and social adjustment
4. Conduct a cost-effectiveness analysis of the interventions
5. Evaluate the interventions from a patient perspective using qualitative methods
Ethics approval
Approved by the Thames Valley Research Ethics Committee in February 2007 (ref: 07/MRE12/6)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Patient information can be found at: http://www.soton.ac.uk/samstrial/links/index.html
Condition
Multiple sclerosis
Intervention
Participants will be randomly allocated to either the CBT or Supportive Listening arm.
CBT arm:
Participants in the CBT arm will look at the way that their thoughts, feelings, behaviours and physiology interact and influence how MS affects their lives. The treatment is structured and different topics will be covered in different sessions. The manual consists of 9 chapters which can be used as appropriate to the individual's needs:
1. Introduction to adjusting to MS
2. Adapting to living with MS
3. Setting goals and problem solving
4. Symptom management
5. How to tackle negative and unhelpful thoughts
6. Improving the quality of your sleep
7. Managing stress
8. Managing social relationships
9. Preparing for the future
Participants will work with their nurse-therapist in setting tasks or homework to do in between the sessions. Participants have 8 sessions of CBT over 10 weeks. This is delivered by general nurses specially trained as nurse-therapists. 2 sessions are face-to-face, 6 are by telephone.
Supportive Listening arm:
Participants in the Supportive Listening arm will have the opportunity to talk freely, extensively and confidentially about their experiences, thoughts and feeling about MS and its effect on their lives. The listening skills we will use in this trial are based on the theories and counselling techniques of Carl Rogers. These core skills include asking open questions, active listening skills such as minimal encouragers and paraphrasing, empathising, reflecting and summarising. The purpose is to provide the participant the opportunity to talk and express themselves in a non-judgmental, safe environment. The person should experience empathy from the therapist and feel listened to. Participants have 8 sessions of Supportive Listening over 10 weeks. This is delivered by general nurses specially trained as nurse therapists. 2 sessions are face-to-face, 6 are by telephone.
Questionnaire assessments will be carried out at baseline, mid-therapy, post-therapy and at 6 and 12 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The following will be assessed at baseline, mid-therapy, post-therapy and at 6 and 12 months:
1. Distress, assessed by the General Health Questionnaire (Goldberg, 1978)
2. Work and Social Adjustment, assessed by the Work and Social Adjustment Scale (Mundt et al., 2002)
Secondary outcome measures
The following will be assessed at baseline, post-therapy and at 6 and 12 months, unless specified otherwise:
1. Social support, assessed using the Significant Others Scale (SOS; Power et al., 1988) at baseline, post-therapy and at 6 and 12 months
2. Beliefs About Emotions (BAE-6; Rimes & Chalder, publication in preparation)
3. Illness perceptions, assessed using the Brief Illness Perception Questionnaire (B-IPQ; Broadbent et al., 2006)
4. Cognitive and Behavioural responses to symptoms (CBSRQ; Moss-Morris et al., publication in preperation)
5. Acceptance, assessed by the Acceptance of Chronic Health Conditions (ACHC) Scale (Stuifbergen et al., in press)
6. Dyadic adjustment, assessed by the Dyadic Adjustment Scale (DAS-4; Sabourin et al., 2005) at baseline and post-therapy
7. Dysfunctional beliefs, assessed by the Psychological Vulnerability Scale (PVS; Sinclair & Wallston, 1999)
8. Health status, assessed by Euroqol (Curtis & Netten, 2006) at baseline, 6 and 12 months
9. Health service usage/costs, assessed using the Client Service Receipt Inventory (CSRI, Beecham & Knapp, 2001) at baseline, 6 and 12 months
Overall trial start date
31/01/2008
Overall trial end date
31/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Definite diagnosis of MS
2. Diagnosed within the last 10 years
3. Some degree of ambulation (with aid if necessary). Equivalent to Extended Disability Status Scale (EDSS) <6.5
4. Stabilised on medication (Disease modifying drugs: minimum of 3 months since started; Anti-depressants: stable dose for minimum of 2 months)
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Gross cognitive impairment that would make participation in therapy problematic or distressing (must score >20 on Telephone Interview for Cognitive Status-Modified to be eligible)
2. Serious psychological disorders for whom treatment would be inappropriate (including psychotic disorders of active substance abuse)
3. Other co-morbid serious chronic illness (e.g., a malignancy)
4. Currently participating in other psychological therapies
Recruitment start date
31/01/2008
Recruitment end date
31/01/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Psychology
Southampton
SO17 1BJ
United Kingdom
Sponsor information
Organisation
University of Southampton and Southampton University Hospitals Trust (UK)
Sponsor details
c/o Dr Martina Dorward
Research Governance Manager
Legal Services
Room 4033
Building 37
University Road
Southampton
SO17 1BJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Multiple Sclerosis Society (refs: 839/06 and 072/07)
Alternative name(s)
MS Society
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19698171
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22730954
Publication citations
-
Protocol
Moss-Morris R, Dennison L, Yardley L, Landau S, Roche S, McCrone P, Chalder T, Protocol for the saMS trial (supportive adjustment for multiple sclerosis): a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis., BMC Neurol, 2009, 9, 45, doi: 10.1186/1471-2377-9-45.
-
Results
Moss-Morris R, Dennison L, Landau S, Yardley L, Silber E, Chalder T, A randomized controlled trial of cognitive behavioral therapy (CBT) for adjusting to multiple sclerosis (the saMS trial): does CBT work and for whom does it work?, J Consult Clin Psychol, 2013, 81, 2, 251-262, doi: 10.1037/a0029132.