A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

NCT ID: NCT02640079

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive behavioral therapy

Cognitive behavioral therapy aimed at reducing pain catastrophizing.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

Interventions

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Laura Payne

Adjunct Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura A Payne, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

15-001761

Identifier Type: -

Identifier Source: org_study_id