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Completed

NCT Number: NCT02640079

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.

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Key information

Conditions

Pain Catastrophizing Primary Dysmenorrhea

Age range

16 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Other outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2015
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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