A RCT of Telephone-supported ACT in MS

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.

Official Title
-----------------
A Feasibility Randomized Control Trial (RCT) of Telephone-supported Acceptance and Commitment Therapy (ACT) for Low Mood in Multiple Sclerosis (MS)

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Behavioral: Telephone-support Acceptance and Commitment Therapy (ACT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale Exclusion Criteria: Already receiving psychotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual<br>Participants carry on with their usual care | |
| Active Comparator: Intervention<br>ACT self help book with telephone support calls; Telephone-support Acceptance and Commitment therapy (ACT) | Behavioral: Telephone-support Acceptance and Commitment Therapy (ACT)<br>* Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment, measured with telephone-interviews. | A sub-sample of participants will be interviewed over the phone to assess their views on their recruitment into the trial. | 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 | 
| Feasibility of randomisation, measured with telephone-interviews. | A sub-sample of participants will be interviewed over the phone to assess their views on how they were randomised. | 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 | 
| Feasibility of psychometric assessment, measured with telephone-interviews. | A sub-sample of participants will be interviewed over the phone to assess their views on the battery of psychometric assessments. | 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 | 
| Feasibility of the self-help book, measured with telephone-interviews. | A sub-sample of participants will be interviewed over the phone to assess their views on the self-help book. | 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 | 
| Feasibility of the telephone-support calls, measured with telephone-interviews. | A sub-sample of participants will be interviewed over the phone to assess their views on the telephone support calls. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness in reducing anxiety, as measured using online psycho-metrics. | Effectiveness will be assessed using quantitative measures which will be completed by participants online. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation | 
| Effectiveness in reducing depression, as measured using online psycho-metrics. | Effectiveness will be assessed using quantitative measures which will be completed by participants online. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation | 
| Effectiveness in reducing physical health problems, as measured using online psycho-metrics. | Effectiveness will be assessed using quantitative measures which will be completed by participants online. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation | 
| Effectiveness in increasing quality of life, as measured using online psycho-metrics. | Effectiveness will be assessed using quantitative measures which will be completed by participants online. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation |