MisophoniaNCT05601284
Psychological Intervention for Misophonia
A study testing Acceptance and commitment therapy and Progressive relaxation training in people with Misophonia, run by Utah State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Misophonia
- What is being tested?
- Acceptance and commitment therapy and Progressive relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Acceptance and commitment therapy (ACT) is a promising psychotherapy for supporting traditional behavioral methods for treating misophonia, but has not been previously tested. ACT teaches skills to develop acceptance, mindfulness, and defusion from difficult internal experiences while increasing connections with personal values and encouraging meaningful behavioral changes.
This study will help determine if ACT+behavioral intervention is a feasible and acceptable treatment for misophonia, help clarify active psychological mechanisms of misophonia, and determine whether or not this combination of services can effectively help individuals diagnosed with misophonia.
- Conditions
- Misophonia
- Being tested
- Acceptance and commitment therapy, Progressive relaxation training
- Medical subject headings
- misophonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
Also called ACT
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.
Progressive relaxation trainingBehavioural
Also called PRT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Progressive relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start24 Oct 2022
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MisophoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Twohig, PhD, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601284
- Sponsor's protocol ID
- 12981
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2022
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bowers EM, Woolley MG, Munoz K, Petersen JM, Twohig MP. Acceptance and commitment therapy versus progressive relaxation training for misophonia: Randomized controlled trial protocol, interventions, and audiological assessments. Contemp Clin Trials. 2024 Oct;145:107671. doi: 10.1016/j.cct.2024.107671. Epub 2024 Aug 29.
PubMed 39182828
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention for Misophonia
- ClinicalTrials.gov ID
- NCT05601284
- Acronym / sponsor ID
- 12981
- Conditions
- Misophonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acceptance and commitment therapy (ACT) is a promising psychotherapy for supporting traditional behavioral methods for treating misophonia, but has not been previously tested. ACT teaches skills to develop acceptance, mindfulness, and defusion from difficult internal experiences while increasing connections with personal values and encouraging meaningful behavioral changes.
This study will help determine if ACT+behavioral intervention is a feasible and acceptable treatment for misophonia, help clarify active psychological mechanisms of misophonia, and determine whether or not this combination of services can effectively help individuals diagnosed with misophonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment therapy | Experimental | Behavioral: Acceptance and commitment therapyACT 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. |
| Progressive relaxation training | Active comparator | Behavioral: Progressive relaxation trainingPRT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and commitment therapyAlso: ACTACT 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. | Behavioural | Acceptance and commitment therapy |
| Progressive relaxation trainingAlso: PRTPRT 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. | Behavioural | Progressive relaxation training |
Primary outcome
Misophonia Questionnaire
Time frame: 9-12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Derived from this study: PubMed 39182828Bowers EM, Woolley MG, Munoz K, Petersen JM, Twohig MP. Acceptance and commitment therapy versus progressive relaxation training for misophonia: Randomized controlled trial protocol, interventions, and audiological assessments. Contemp Clin Trials. 2024 Oct;145:107671. doi: 10.1016/j.cct.2024.107671. Epub 2024 Aug 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Twohig, PhD principal investigator
Utah State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy and Progressive relaxation training in people with Misophonia, run by Utah State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Misophonia Questionnaire (time frame: 9-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05601284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.