Clinical trial NCT06443164: Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Official title: Efficacy of a Single-session Treatment for Reducing Chronic Pain Prior to Gender-affirming Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Transgenderism
Pain Catastrophizing
Pain, Chronic
Gender Identity
Keywords: Chronic Pain
Gender Diversity
Gender Affirming Surgery
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional Group Control Group
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender or gender-diverse patients with chronic pain prior to gender-affirming surgery, to determine if participants who receive the intervention have less pain-related distress compared to participants randomly assigned to the control group.

Detailed description: The primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender and gender-diverse patients with chronic pain prior to gender-affirming surgery, to determine if participants who receive the intervention have less pain-related distress compared to participants randomly assigned to the control group. This study will help extend the research literature on chronic pain experienced by transgender patients, and specifically will examine if a brief, group intervention is effective for reducing pain catastrophizing and pain distress prior to surgery.

Safety and effectiveness of the Empowered Relief intervention used in this study has been demonstrated in multiple clinical trials, but has not been studied yet with this particular population. The Empowered relief intervention was created by Beth Darnall © Stanford University.

The hypothesis of this research study is that transgender patients with chronic pain who receive the group intervention, prior to having a gender-affirming surgery, will have lower scores on the pain catastrophizing scale after completing the intervention compared to participants in the control group:

Hypothesis: µ1 \<(\<=) µ2. The primary endpoint of this study is to test if the mean change in the score on the Pain Catastrophizing Scale is different between the treatment and the control group. The secondary endpoint, is to examine if pain severity scores decreased. An exploratory endpoint, after data collection and analysis is complete, is to run a focus group with participants who received the intervention to learn more about their experience to inform future treatment and research. Safety endpoints are that participants will receive informed consent, which will include learning they may discontinue participation in the study at any time, as well as procedures for maintaining confidentiality of identifying information. Each person screened will already be referred to the Transgender Health Program by a primary care provider and/or mental health provider. If screening indicates that a person has severe depression or regular thoughts involving suicidal content, then that person will not be included in the study but instead will be offered resources and highly recommended to contact their referring provider for additional support.

Eligibility criteria: Inclusion Criteria:

1. affiliated with the OHSU Transgender Health Program and have completed their initial consultation for gender-affirming surgery,
2. who have chronic pain (defined as \> 3 months of pain),
3. who rate their average level of pain intensity as at least a 4 or higher (on 0-10 pain scale)
4. who have fluency in English. Empowered Relief may only be delivered by a certified instructor, and for this research study the instructor is only able to offer the curriculum in English.

Exclusion Criteria:

1. have had a pain-focused behavioral therapy in the past year, or
2. have severe depression and/or moderate or higher risk of suicidality based on the person's score on the PHQ-9 greater than 20.

Primary outcomes:
measure: Pain Catastrophizing
timeFrame: Participants will be assessed as part of a cohort for up to 7 months. There will be a total of three cohorts.
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Comprehensive Pain Center
state: Oregon
Study officials:
References: