Clinical trial NCT02596633: A RCT of Telephone-supported ACT in MS
Official title: A Feasibility Randomized Control Trial (RCT) of Telephone-supported Acceptance and Commitment Therapy (ACT) for Low Mood in Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Already receiving psychotherapy

Primary outcomes:
measure: Feasibility of recruitment, measured with telephone-interviews.
timeFrame: 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
measure: Feasibility of randomisation, measured with telephone-interviews.
timeFrame: 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
measure: Feasibility of psychometric assessment, measured with telephone-interviews.
timeFrame: 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
measure: Feasibility of the self-help book, measured with telephone-interviews.
timeFrame: 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
measure: Feasibility of the telephone-support calls, measured with telephone-interviews.
timeFrame: 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.
timeFrame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
measure: Effectiveness in reducing depression, as measured using online psycho-metrics.
timeFrame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
measure: Effectiveness in reducing physical health problems, as measured using online psycho-metrics.
timeFrame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
measure: Effectiveness in increasing quality of life, as measured using online psycho-metrics.
timeFrame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Other outcomes:
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