A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

University of California, Los Angeles1 site in 1 country24 target enrollmentJanuary 2016

Overview

Brief Summary

The purpose of this study is to test the feasibility and efficacy of a brief group therapy treatment program focused on reducing pain catastrophizing in adolescents and young adults (ages 16-25) with menstrual pain.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

November 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of California, Los Angeles

Responsible Party

Principal Investigator

Laura Payne

Adjunct Assistant Professor

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

•Female ages 16-25 years
•Self-reported menstrual cycle averaging 24-32 days
•Menstrual pain rating of ≥4 on the Numeric Rating Scale for at least the previous three menstrual cycles prior to participation
•Written informed consent or assent (if a minor, parent must also provide written parental permission)
•Able to read and understand English

Exclusion Criteria

•Use of oral contraceptives or any exogenous hormones in the previous 3 months
•Presence of persistent pelvic pain throughout the menstrual cycle
•Acute illness or injury that may impact lab performance or that affects sensitivity of the extremities
•Diagnosis of an underlying medical cause for dysmenorrhea symptoms
•No or minimal menstrual pain (NRS rating of ≤ 3) during any of the 3 previous cycles prior to study participation
•Daily use of opioids; participants using other analgesics will be included, but will be asked not to take these analgesics on the days of the lab sessions
•Developmental delay, autism, or significant anatomic impairment that may preclude understanding of study procedures

Outcomes

Primary Outcomes

Feasibility (as determined by attrition rate)

Time Frame: After each cohort completes their 5 group CBT sessions; 1 week after the 5th and final CBT session in each cohort

Change in menstrual pain level assessed via 11-point numeric rating scale (NRS)

Time Frame: Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion

Change in medication use (dosage and frequency of pain medication use)

Time Frame: Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion

Acceptability - participants' views of the intervention's 1) appeal; 2) helpfulness; and 3) ease of participation

Time Frame: Assessed via qualitative interviews which will occur during each participant's post-intervention lab assessment (i.e., during the first two days of the first menstrual period after intervention completion)

Change in pain catastrophizing

Time Frame: Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion

Secondary Outcomes

Change in menstrual symptoms as assessed by the Menstrual Symptom Questionnaire (MSQ)(Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion)
Change in anxiety as assessed by the Brief Symptom Inventory 18 (BSI-18)(Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion)
Change in depression as assessed by the Brief Symptom Inventory 18 (BSI-18)(Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion)
Change in temporal summation (TS)(Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation)
Change in conditioned pain modulation (CPM): pain ratings in response to a heat stimulus prior to and after administration of a conditioning pain stimulus (cold water)(Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation)
Change in somatization as assessed by the Brief Symptom Inventory 18 (BSI-18)(Assessed via questionnaire completed at six time points: pre-intervention lab session, immediately following the completion of the 5th group CBT session, post-intervention lab session, and once a month for three months after intervention completion)