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A RCT of Telephone-supported ACT in MS

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Telephone-support Acceptance and Commitment Therapy (ACT)
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Already receiving psychotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Treatment as Usual

    Intervention

    Arm Description

    Participants carry on with their usual care

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Effectiveness in reducing anxiety, as measured using online psycho-metrics.
    Effectiveness will be assessed using quantitative measures which will be completed by participants online.
    Effectiveness in reducing depression, as measured using online psycho-metrics.
    Effectiveness will be assessed using quantitative measures which will be completed by participants online.
    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.
    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.

    Full Information

    First Posted
    October 16, 2015
    Last Updated
    February 17, 2016
    Sponsor
    University of Nottingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02596633
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    March 2016 (Anticipated)
    Study Completion Date
    April 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nottingham

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment as Usual
    Arm Type
    No Intervention
    Arm Description
    Participants carry on with their usual care
    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    ACT self help book with telephone support calls; Telephone-support Acceptance and Commitment therapy (ACT)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Telephone-support Acceptance and Commitment Therapy (ACT)
    Intervention Description
    Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls
    Primary Outcome Measure Information:
    Title
    Feasibility of recruitment, measured with telephone-interviews.
    Description
    A sub-sample of participants will be interviewed over the phone to assess their views on their recruitment into the trial.
    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
    Title
    Feasibility of randomisation, measured with telephone-interviews.
    Description
    A sub-sample of participants will be interviewed over the phone to assess their views on how they were randomised.
    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
    Title
    Feasibility of psychometric assessment, measured with telephone-interviews.
    Description
    A sub-sample of participants will be interviewed over the phone to assess their views on the battery of psychometric assessments.
    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
    Title
    Feasibility of the self-help book, measured with telephone-interviews.
    Description
    A sub-sample of participants will be interviewed over the phone to assess their views on the self-help book.
    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
    Title
    Feasibility of the telephone-support calls, measured with telephone-interviews.
    Description
    A sub-sample of participants will be interviewed over the phone to assess their views on the telephone support calls.
    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 Outcome Measure Information:
    Title
    Effectiveness in reducing anxiety, as measured using online psycho-metrics.
    Description
    Effectiveness will be assessed using quantitative measures which will be completed by participants online.
    Time Frame
    At post-intervention (12 weeks after randomisation) and 6 months after randomisation
    Title
    Effectiveness in reducing depression, as measured using online psycho-metrics.
    Description
    Effectiveness will be assessed using quantitative measures which will be completed by participants online.
    Time Frame
    At post-intervention (12 weeks after randomisation) and 6 months after randomisation
    Title
    Effectiveness in reducing physical health problems, as measured using online psycho-metrics.
    Description
    Effectiveness will be assessed using quantitative measures which will be completed by participants online.
    Time Frame
    At post-intervention (12 weeks after randomisation) and 6 months after randomisation
    Title
    Effectiveness in increasing quality of life, as measured using online psycho-metrics.
    Description
    Effectiveness will be assessed using quantitative measures which will be completed by participants online.
    Time Frame
    At post-intervention (12 weeks after randomisation) and 6 months after randomisation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale Exclusion Criteria: Already receiving psychotherapy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A RCT of Telephone-supported ACT in MS

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