A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

April 11, 2018 updated by: Laura Payne, University of California, Los Angeles
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive behavioral therapy
Cognitive behavioral therapy aimed at reducing pain catastrophizing.
Behavioral: Cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Feasibility (as determined by attrition rate)
Time Frame: After each cohort completes their 5 group CBT sessions; 1 week after the 5th and final CBT session in each cohort
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
Time Frame: 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)
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
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in menstrual symptoms as assessed by the Menstrual Symptom Questionnaire (MSQ)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation
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)
Time Frame: Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation
Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Galvanic Skin Response (GSR)
Time Frame: 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)
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)
Time Frame: 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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura A Payne, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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