NCT05601284

Brief Summary

The investigators are proposing to test Acceptance and Commitment Therapy (ACT)+ traditional audiological behavioral intervention as an integrated, multi-disciplinary approach for the assessment and treatment of misophonia. Participants will be 60 adults with misophonia and will be randomly assigned to receive 12 sessions of ACT+behavioral intervention or receive 12 weeks of progressive relaxation training+psychoeducation (PRT; a commonly used active control condition) after undergoing a comprehensive psychological and audiological evaluation.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

July 26, 2024

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

October 26, 2022

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Misophonia Questionnaire

    Self-report of misophonia symptoms. There are two subscales. The first subscale (misophonia symptoms) ranges from 0 to 76 and the second (misophonia severity) ranges from 1 to 15. For both subscales, higher scores indicate worse outcomes.

    9-12 months

Study Arms (2)

Acceptance and commitment therapy

EXPERIMENTAL

ACT teaches skills to develop acceptance, mindfulness, and defusion from difficult internal experiences while increasing connections with personal values and encouraging meaningful behavioral changes. ACT for misophonia combines core ACT processes with a traditional audiological behavioral intervention for a integrated, multi-disciplinary approach for the assessment and treatment of misophonia. Treatment begins with a brief focus on the behavioral intervention, followed by the teaching of ACT skills to support the use of the behavioral methods. The intervention consists of 12 total individual sessions of ACT+behavioral management.

Behavioral: Acceptance and commitment therapy

Progressive relaxation training

ACTIVE COMPARATOR

PRT for misophonia consists of basic psychoeducation for misophonia followed by PRT. PRT involves learning to tense and relax muscles. Early sessions focus on tensing and relaxing smaller muscle groups, while later sessions focus on larger muscle groups. Final sessions focus on relaxation as produced by recalling previous relaxation and a review of skills learned. PRT consists of 12 individual total sessions.

Behavioral: Progressive relaxation training

Interventions

ACT teaches skills to develop acceptance, mindfulness, and defusion from difficult internal experiences while increasing connections with personal values and encouraging meaningful behavioral changes. ACT for misophonia combines core ACT processes with a traditional audiological behavioral intervention for a integrated, multi-disciplinary approach for the assessment and treatment of misophonia. Treatment begins with a brief focus on the behavioral intervention, followed by the teaching of ACT skills to support the use of the behavioral methods. The intervention consists of 12 total individual sessions of ACT+behavioral management.

Also known as: ACT
Acceptance and commitment therapy

PRT for misophonia consists of basic psychoeducation for misophonia followed by PRT. PRT involves learning to tense and relax muscles. Early sessions focus on tensing and relaxing smaller muscle groups, while later sessions focus on larger muscle groups. Final sessions focus on relaxation as produced by recalling previous relaxation and a review of skills learned. PRT consists of 12 individual total sessions.

Also known as: PRT
Progressive relaxation training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals seeking treatment for misophonia.
  • Meet clinical cut-off for misphonia (minimum score of five on the Misophonia Questionnaire).
  • Stable on psychotropic medication for at least 30 days.
  • English speaking.

You may not qualify if:

  • Presence of psychological and/or neurological impairments that would preclude someone from participating in the study or exceed misophonia as the primary presenting problem (e.g. active self-harm or need for treatment for psychosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84341, United States

Location

MeSH Terms

Conditions

misophonia

Interventions

Acceptance and Commitment TherapyAutogenic Training

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesHypnosisMind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Michael Twohig, PhD

    Utah State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 1, 2022

Study Start

October 24, 2022

Primary Completion

October 30, 2025

Study Completion

April 30, 2026

Last Updated

July 26, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations