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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN91377356
Enrollment
100
Registered
2008-04-11
Start date
2008-01-31
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

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 physiol

Sponsors

University of Southampton and Southampton University Hospitals Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026