A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea; Pain Catastrophizing

• Registration Number: NCT02640079
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Study Start: 2016-01
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility (as determined by attrition rate)	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)	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)	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	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	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States