A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

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.

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea; Pain Catastrophizing
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavioral therapy; Cognitive behavioral therapy aimed at reducing pain catastrophizing.	Behavioral: Cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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
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

Other Outcome Measures

Outcome Measure	Time Frame
Galvanic Skin Response (GSR)	Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation; GSR assessed at rest (5 min), during four pain induction tasks (3-5 min each), and again at rest (5 min)
Heart Rate Variability (HRV)	Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation; HRV assessed at rest (5 min), during four pain induction tasks (3-5 min each), and again at rest (5 min)

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Laura A Payne, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (Estimate): December 28, 2015

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Laboratory pain responsivity
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 15-001761

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No