Chronic PainNCT06865560
Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder
A study testing Emotional Awareness and Expression Therapy (EAET) in people with Chronic Pain and Opioid Use Disorder, run by University of Michigan at 1 site in United States.
Trial summary
The study is intended to test whether a group-based Zoom behavioral treatment can help adults with chronic pain and opioid use disorder (OUD) learn effective strategies for reducing pain, disability and other problems that can come with these conditions (such as depression, anxiety, and difficulty managing emotions). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use Disorder
- What is being tested?
- Emotional Awareness and Expression Therapy (EAET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to 7 Dec 2025
- 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
- Be able to read, write and speak English
- Have Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home
- Widespread pain and has opioid use disorder (OUD)
Who cannot join
- Diagnosis of autoimmune disease, spinal cord injury, cancer.
- Currently receiving cognitive-behavioral therapy, EAET, or other psychological therapies for pain
- Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening.
- Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols.
- Pregnant or breastfeeding
- Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder - A Pilot Study
The study is intended to test whether a group-based Zoom behavioral treatment can help adults with chronic pain and opioid use disorder (OUD) learn effective strategies for reducing pain, disability and other problems that can come with these conditions (such as depression, anxiety, and difficulty managing emotions).
Read the detailed description
Emotional Awareness and Expression Therapy (EAET) is a behavioral therapy that focuses on reducing chronic pain by helping people work on the effects of stress, trauma, and emotions that they have experienced in their lives. It is delivered in group sessions of 5-7 individuals by trained therapists who treat emotions or problems in relationships to reduce chronic pain. Pain decreases through increased recognition and expression of emotions, and learning to feel safe in the presence of emotions.
The primary aim of the study is to demonstrate the feasibility, acceptability, and preliminary efficacy of the proposed EAET intervention in adults with chronic pain and opioid use disorder.
- Conditions
- Chronic Pain, Opioid Use Disorder
- Being tested
- Emotional Awareness and Expression Therapy (EAET)
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression Therapy (EAET)Behavioural
A validated, 8-week, group-based telehealth-based behavioral intervention for chronic pain. Session content will include pain neuroscience education, emotion-focused expressive writing, in-vivo emotional expression practices, self-compassion and forgiveness exercises, and assertive communication strategies. Participants will also be provided handouts and pre-recorded guided imagery and cognitive exercises that they can use to facilitate between-session practices.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Awareness and Expression Therapy (EAET) | Experimental | Adults with chronic pain and mild to moderate opioid use disorder (OUD). Receives: Behavioral: Emotional Awareness and Expression Therapy (EAET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.
The TAAS is a validated instrument for behavioral interventions. Although no validated cutoff scores exist for this measure, prior research has used an informal cutoff score at the midpoint of the total score (i.e., 35 out of a possible 70) as a measure of moderate acceptability. If the EAET intervention is ineffective, low acceptability may be an explanatory factor. - scores above the midpoint - 35 out of 70 - will denote moderate acceptability of the intervention
Measured: Approximately day 70
Feasibility: Session attendance
Measured: Approximately day 70
Feasibility: Combined completion of in-session and between-session practices
Measured: Approximately day 70
Secondary outcomes (4)
Change in Brief Pain Inventory (BPI) pain intensity
The BPI pain intensity is a validated 4-item measure of pain intensity.
Change is measured from day 1 to day 70 AND day 1 to day 160
Measured: Day 1 and up to day 160
Change in Pain-related OUD Exacerbation Scale (PrOUD-ES)
Validated 4-item scale assessing self-reported degree of pain-related OUD symptom exacerbation.
Change is measured from day 1 to day 70 AND day 1 to day 160
Measured: Day 1 and up to day 160
Change in Opioid Craving Visual Analog Scale (OC-VAS)
The OC-VAS is a validated single-item assessment utilizing 0-100 scale reflecting degree of opioid craving.
Change is measured from day 1 to day 70 AND day 1 to day 160
Measured: Day 1 and up to day 160
Change in Current Opioid Misuse Measure-Brief (COMM-9)
The Comm-9 is a validated 9-item self-report measure of opioid misuse.
Change is measured from day 1 to day 70 AND day 1 to day 160
Measured: Day 1 and up to day 160
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start3 Jun 2025
- Primary completion5 Oct 2025
- Study completion7 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Sturgeon, University of Michigan
- Investigators
- John Sturgeon, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865560
- Sponsor's protocol ID
- HUM00266504
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder - A Pilot Study
- ClinicalTrials.gov ID
- NCT06865560
- Acronym / sponsor ID
- HUM00266504
- Conditions
- Chronic Pain, Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 5 Oct 2025 (actual)
- Study completion
- 7 Dec 2025 (actual)
- First posted
- 10 Mar 2025 (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 study is intended to test whether a group-based Zoom behavioral treatment can help adults with chronic pain and opioid use disorder (OUD) learn effective strategies for reducing pain, disability and other problems that can come with these conditions (such as depression, anxiety, and difficulty managing emotions).
Detailed description
Emotional Awareness and Expression Therapy (EAET) is a behavioral therapy that focuses on reducing chronic pain by helping people work on the effects of stress, trauma, and emotions that they have experienced in their lives. It is delivered in group sessions of 5-7 individuals by trained therapists who treat emotions or problems in relationships to reduce chronic pain. Pain decreases through increased recognition and expression of emotions, and learning to feel safe in the presence of emotions.
The primary aim of the study is to demonstrate the feasibility, acceptability, and preliminary efficacy of the proposed EAET intervention in adults with chronic pain and opioid use disorder.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emotional Awareness and Expression Therapy (EAET) | Experimental | Behavioral: Emotional Awareness and Expression Therapy (EAET)Adults with chronic pain and mild to moderate opioid use disorder (OUD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be able to read, write and speak English
- Have Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home
- Widespread pain and has opioid use disorder (OUD)
Key exclusion criteria (6 listed)
- Diagnosis of autoimmune disease, spinal cord injury, cancer.
- Currently receiving cognitive-behavioral therapy, EAET, or other psychological therapies for pain
- Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening.
- Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols.
- Pregnant or breastfeeding
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 |
|---|---|---|
| Emotional Awareness and Expression Therapy (EAET)A validated, 8-week, group-based telehealth-based behavioral intervention for chronic pain. Session content will include pain neuroscience education, emotion-focused expressive writing, in-vivo emotional expression practices, self-compassion and forgiveness exercises, and assertive communication strategies. Participants will also be provided handouts and pre-recorded guided imagery and cognitive exercises that they can use to facilitate between-session practices. | Behavioural | Emotional Awareness and Expression Therapy (EAET) |
Primary outcome
Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.
Time frame: Approximately day 70
The TAAS is a validated instrument for behavioral interventions. Although no validated cutoff scores exist for this measure, prior research has used an informal cutoff score at the midpoint of the total score (i.e., 35 out of a possible 70) as a measure of moderate acceptability. If the EAET intervention is ineffective, low acceptability may be an explanatory factor. - scores above the midpoint - 35 out of 70 - will denote moderate acceptability of the intervention
Feasibility: Session attendance
Time frame: Approximately day 70
Feasibility: Combined completion of in-session and between-session practices
Time frame: Approximately day 70
4 secondary outcomes
Change in Brief Pain Inventory (BPI) pain intensity
Time frame: Day 1 and up to day 160
Change in Pain-related OUD Exacerbation Scale (PrOUD-ES)
Time frame: Day 1 and up to day 160
Change in Opioid Craving Visual Analog Scale (OC-VAS)
Time frame: Day 1 and up to day 160
Change in Current Opioid Misuse Measure-Brief (COMM-9)
Time frame: Day 1 and up to day 160
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- 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.
John Sturgeon, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness and Expression Therapy (EAET) in people with Chronic Pain and Opioid Use Disorder, run by University of Michigan 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint. (time frame: Approximately day 70). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.