Condition category
Nervous System Diseases
Date applied
07/01/2008
Date assigned
11/04/2008
Last edited
22/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Rona Moss-Morris

ORCID ID

Contact details

School of Psychology
University of Southampton
Highfield Campus
Southampton
SO17 1BJ
United Kingdom

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

http://www.soton.ac.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes