Cognitive behavioural therapy (CBT) for adjustment to early stage multiple sclerosis: Manual development and a randomised controlled trial comparing CBT to supportive listening

ISRCTN ISRCTN91377356
DOI https://doi.org/10.1186/ISRCTN91377356
Protocol serial number RHM MED 0726
Sponsor University of Southampton and Southampton University Hospitals Trust (UK)
Funder Multiple Sclerosis Society (refs: 839/06 and 072/07)
Submission date
07/01/2008
Registration date
11/04/2008
Last edited
22/10/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.southampton.ac.uk/samstrial/trial/about_the_trial1.html

Contact information

Prof Rona Moss-Morris
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study acronymsaMS (Supportive Adjustment for Multiple Sclerosis)
Study objectivesMultiple 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(s)Approved by the Thames Valley Research Ethics Committee in February 2007 (ref: 07/MRE12/6)
Health condition(s) or problem(s) studiedMultiple sclerosis
InterventionParticipants 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 typeOther
Primary outcome measure(s)

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)

Key secondary outcome measure(s)

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

Completion date31/01/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexAll
Target sample size at registration100
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment31/01/2008
Date of final enrolment31/01/2009

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

School of Psychology
Southampton
SO17 1BJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2013 Yes No
Protocol article protocol 23/08/2009 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes
BMC - Part of Springer Nature Springer Nature