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Completed

NCT Number: NCT06865560

Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Emotional Awareness and Expression Therapy (EAET)

Behavioral

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.

Primary outcomes

  1. 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

  2. Feasibility: Session attendance

    Time frame: Approximately day 70

  3. Feasibility: Combined completion of in-session and between-session practices

    Time frame: Approximately day 70

Secondary outcomes

  1. Change in Brief Pain Inventory (BPI) pain intensity

    Time frame: Day 1 and up to day 160

    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

  2. Change in Pain-related OUD Exacerbation Scale (PrOUD-ES)

    Time frame: Day 1 and up to day 160

    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

  3. Change in Opioid Craving Visual Analog Scale (OC-VAS)

    Time frame: Day 1 and up to day 160

    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

  4. Change in Current Opioid Misuse Measure-Brief (COMM-9)

    Time frame: Day 1 and up to day 160

    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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder - A Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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