Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment telephone-support acceptance and commitment therapy (act)
Phase phase 3
Sponsor University of Nottingham
Start date January 2015
End date March 2016
Trial size 30 participants
Trial identifier NCT02596633, 14094

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(No Intervention)
Participants carry on with their usual care
(Active Comparator)
ACT self help book with telephone support calls; Telephone-support Acceptance and Commitment therapy (ACT)
telephone-support acceptance and commitment therapy (act)
Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls

Primary Outcomes

Measure
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
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
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
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
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

Secondary Outcomes

Measure
Effectiveness in reducing anxiety, as measured using online psycho-metrics.
time frame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Effectiveness in reducing depression, as measured using online psycho-metrics.
time frame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Effectiveness in reducing physical health problems, as measured using online psycho-metrics.
time frame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Effectiveness in increasing quality of life, as measured using online psycho-metrics.
time frame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Feasibility Randomized Control Trial (RCT) of Telephone-supported Acceptance and Commitment Therapy (ACT) for Low Mood in Multiple Sclerosis (MS)
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Nottingham.