A RCT of Telephone-supported ACT in MS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02596633
• Other study ID #: 14094
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 16, 2015
• Last updated: February 17, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Already receiving psychotherapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Telephone-support Acceptance and Commitment Therapy (ACT)
Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No