A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640079
• Other study ID #: 15-001761
• Status: Completed
• Phase: N/A
• First received: December 17, 2015
• Last updated: April 11, 2018
• Start date: January 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Gender: Female
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Pain Catastrophizing
• Primary Dysmenorrhea

Intervention

Behavioral:
• Cognitive behavioral therapy

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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