A RCT of Telephone-supported ACT in MS
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT02596633
- Lead Sponsor
- University of Nottingham
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale
- Already receiving psychotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 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 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.
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 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.
- Secondary Outcome Measures
Name Time Method 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.
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 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.