A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

NCT02640079 | Completed

• 1 other identifier: 15-001761
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Catastrophizing; Primary Dysmenorrhea

Keywords

Cognitive behavioral therapy; Laboratory pain responsivity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• 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

Other Outcomes (2)

• 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)

Study Arms (1)

Cognitive behavioral therapy

EXPERIMENTAL

Cognitive behavioral therapy aimed at reducing pain catastrophizing.

Behavioral: Cognitive behavioral therapy

Interventions

Cognitive behavioral therapy BEHAVIORAL

Cognitive behavioral therapy

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Laura A Payne, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 28, 2015
• Study Start: January 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

US (1)