A RCT of Telephone-supported ACT in MS

NCT ID: NCT02596633

Last Updated: 2016-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment as Usual

Participants carry on with their usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

ACT self help book with telephone support calls; Telephone-support Acceptance and Commitment therapy (ACT)

Group Type ACTIVE_COMPARATOR

Telephone-support Acceptance and Commitment Therapy (ACT)

Intervention Type BEHAVIORAL

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

Interventions

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Telephone-support Acceptance and Commitment Therapy (ACT)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Already receiving psychotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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14094

Identifier Type: -

Identifier Source: org_study_id

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