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A Comparison of the Benefits of Mindfulness Based Cognitive Therapy, Relaxation Therapy and a Waiting List Control in the Management of Distress in Chronic Tinnitus Patients

NCT02059447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-12-03

No results posted yet for this study

Summary

The principal hypotheses to be tested is that Mindfulness Based Cognitive Therapy (MBCT) reduces the distressing impact of tinnitus to a significantly greater extent than a waiting list control or relaxation therapy.

This study is a mixed design, with two groups assessed at a number of time points. The primary outcome measure will be that of tinnitus distress, and secondary outcomes will be taken of psychological distress and tinnitus loudness.

The outcome measures will be measured first at 8 weeks pre-treatment. All subjects then wait for 8 weeks before being randomly allocated to either an 8 week course of Mindfulness-Based Cognitive Therapy (MBCT) (Group 1) or an 8 week course of Relaxation Therapy (RT) (Group 2). All participants will be assessed at two main time-points (pre and post-treatment). The outcome measures will be repeated at 1 and 6 month follow-up points.

Conditions

  • Tinnitus

Interventions

OTHER

No treatment waiting period

All subjects undergo a no treatment waiting period before being randomly allocated to either Mindfulness Based Cognitive Therapy or Relaxation Therapy

BEHAVIORAL

Mindfulness Based Cognitive Therapy

BEHAVIORAL

Relaxation Therapy

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • British Tinnitus Association

    collaborator OTHER

  • University College London Hospitals

    lead OTHER

Principal Investigators

  • Laurence McKenna, PhD · Royal National Throat Nose & Ear Hospital, University College London Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059447 on ClinicalTrials.gov