A Feasibility Randomized Control Trial (RCT) of Telephone-supported Acceptance and Commitment Therapy (ACT) for Low Mood in Multiple Sclerosis (MS)
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- University of Nottingham
- Enrollment
- 30
- Primary Endpoint
- Feasibility of the telephone-support calls, measured with telephone-interviews.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale
Exclusion Criteria
- •Already receiving psychotherapy
Arms & Interventions
Treatment as Usual
Participants carry on with their usual care
Intervention
ACT self help book with telephone support calls; Telephone-support Acceptance and Commitment therapy (ACT)
Intervention: Telephone-support Acceptance and Commitment Therapy (ACT) (Behavioral)
Outcomes
Primary Outcomes
Feasibility of the telephone-support calls, measured with telephone-interviews.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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 Outcomes
- Effectiveness in reducing anxiety, as measured using online psycho-metrics.(At post-intervention (12 weeks after randomisation) and 6 months after randomisation)
- 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 in increasing quality of life, as measured using online psycho-metrics.(At post-intervention (12 weeks after randomisation) and 6 months after randomisation)
- Effectiveness in reducing depression, as measured using online psycho-metrics.(At post-intervention (12 weeks after randomisation) and 6 months after randomisation)