A RCT of Telephone-supported ACT in MS

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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Telephone-support Acceptance and Commitment Therapy (ACT)

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale

Exclusion Criteria:

• Already receiving psychotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Nottingham

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: February 17, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 14094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No