Multiple Sclerosis
Conditions
Brief summary
This study will investigate the feasibility of running a randomised controlled trial (RCT) of a psychotherapy called Acceptance and Commitment Therapy (ACT), delivered in a self-help format with additional telephone support from a therapist, for people with Multiple Sclerosis (MS) and low mood.
Detailed description
A large proportion of people with Multiple Sclerosis (MS) suffer from emotional problems, therefore a large percentage of people with MS would be eligible to take part in a study offering a psychotherapeutic component to address these issues. Acceptance and Commitment Therapy (ACT) has been found to be effective for mood problems, and been successfully used in self-help format, but no study has thus-far examined potential for use as an effective intervention in this (MS) population. People will MS and low mood will be recruited from a neurology outpatient clinic. They will be randomized to either receive treatment as usual, or an ACT self-help book with 8 supportive telephone calls from a trainee clinical psychologist. Measures of anxiety, depression, quality of life and physical health will be administered at baseline, post-intervention and six month follow up. A sub sample of 10 participants will be interviewed to find out their view on taking part in the study.
Interventions
BEHAVIORALTelephone-support Acceptance and Commitment Therapy (ACT)
Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls
Sponsors
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale
Exclusion criteria
* Already receiving psychotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the telephone-support calls, measured with telephone-interviews. | At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm | A sub-sample of participants will be interviewed over the phone to assess their views on the telephone support calls. |
| Feasibility of recruitment, measured with telephone-interviews. | At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm | A sub-sample of participants will be interviewed over the phone to assess their views on their recruitment into the trial. |
| Feasibility of randomisation, measured with telephone-interviews. | At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm | A sub-sample of participants will be interviewed over the phone to assess their views on how they were randomised. |
| Feasibility of psychometric assessment, measured with telephone-interviews. | At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm | A sub-sample of participants will be interviewed over the phone to assess their views on the battery of psychometric assessments. |
| Feasibility of the self-help book, measured with telephone-interviews. | At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm | A sub-sample of participants will be interviewed over the phone to assess their views on the self-help book. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness in reducing depression, as measured using online psycho-metrics. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation | Effectiveness will be assessed using quantitative measures which will be completed by participants online. |
| Effectiveness in reducing physical health problems, as measured using online psycho-metrics. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation | Effectiveness will be assessed using quantitative measures which will be completed by participants online. |
| Effectiveness in increasing quality of life, as measured using online psycho-metrics. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation | Effectiveness will be assessed using quantitative measures which will be completed by participants online. |
| Effectiveness in reducing anxiety, as measured using online psycho-metrics. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation | Effectiveness will be assessed using quantitative measures which will be completed by participants online. |
Outcome results
None listed