A RCT of Telephone-supported ACT in MS

NCT02596633 | Unknown Phase 3

• 1 other identifier: 14094
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (4)

• Effectiveness in reducing anxiety, as measured using online psycho-metrics.

  At post-intervention (12 weeks after randomisation) and 6 months after randomisation

• Effectiveness in reducing depression, as measured using online psycho-metrics.

  At post-intervention (12 weeks after randomisation) and 6 months after randomisation

• Effectiveness in reducing physical health problems, as measured using online psycho-metrics.

  At post-intervention (12 weeks after randomisation) and 6 months after randomisation

• Effectiveness in increasing quality of life, as measured using online psycho-metrics.

  At post-intervention (12 weeks after randomisation) and 6 months after randomisation

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Participants carry on with their usual care

Intervention

ACTIVE COMPARATOR

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

Behavioral: Telephone-support Acceptance and Commitment Therapy (ACT)

Interventions

Telephone-support Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Already receiving psychotherapy

Sponsors & Collaborators

• University of Nottingham: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: November 4, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 18, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share