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 | Completed

• 1 other identifier: Tinnitus MBCT
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Controlled trial; Active control; Waiting, non treatment, period; Mindfulness Based Cognitive Therapy; Relaxation Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Tinnitus Questionnaire score over time

  8 weeks pre treatment; start of treatment; end of treatment; 1 month post treatment; 6 months post treatment

Secondary Outcomes (1)

• Change in Clinical Outcomes in Routine Evaluation (Outcome measure) score over time

  8 weeks pre treatment; start of treatment; end of treatment; 1 month post treatment; 6 months post treatment

Other Outcomes (8)

• Change in Tinnitus Functional Index score over time

  8 weeks pre treatment; start of treatment, end of treatment, 1 month post treatment; 6 months post treatment

• Change in Mindful Attention Awareness Scale score over time

  8 weeks pre treatment; start of treatment; end of treatment, 1 month post treatment; 6 months post treatment

• Change in Tinnitus Acceptance Questionnaire score over time

  8 weeks pre treatment; start of treatment; end of treatment; 1 month post treatment; 6 months post treatment

Study Arms (2)

Mindfulness Based Cognitive Therapy

EXPERIMENTAL

An 8 week course of Mindfulness Based Cognitive therapy

Other: No treatment waiting period; Behavioral: Mindfulness Based Cognitive Therapy

Relaxation Therapy

ACTIVE COMPARATOR

An 8 week course of Relaxation Therapy.

Other: No treatment waiting period; Behavioral: Relaxation Therapy

Interventions

No treatment waiting period OTHER

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

Mindfulness Based Cognitive Therapy; Relaxation Therapy

Mindfulness Based Cognitive Therapy BEHAVIORAL

Mindfulness Based Cognitive Therapy

Relaxation Therapy BEHAVIORAL

Relaxation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only patients with chronic tinnitus (i.e. have had tinnitus for six months or more) will be included
• Only patients who show at least a minimum level of distress (defined by a cut off score on the CORE measure of psychological well-being).
• Only patients whose hearing permits them to take part in group discussions in a quiet room will be included.
• Only patients with sufficient understanding of English to take part in group discussions and complete questionnaires will be included.

You may not qualify if:

• \. Patients who are subject to ongoing medical investigations will be excluded. Patients who are alcohol or drug dependent will be excluded Patients who are suffering with psychosis or who are actively suicidal will be excluded.

Sponsors & Collaborators

• University College London Hospitals: lead
• University College, London: collaborator
• British Tinnitus Association: collaborator

Study Sites (1)

Royal National Throat Nose & Ear Hospital, University College London Hospitals

London, England, WC1 8DA, United Kingdom

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Mindfulness-Based Cognitive Therapy; Relaxation Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Laurence McKenna, PhD

  Royal National Throat Nose & Ear Hospital, University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical psychologist

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: February 11, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

GB (1)