A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

Study Overview
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Brief Summary
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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.

Official Title
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A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

Conditions
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Pain Catastrophizing, Primary Dysmenorrhea

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral therapy<br>Cognitive behavioral therapy aimed at reducing pain catastrophizing. | Behavioral: Cognitive behavioral therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavioral therapy, Laboratory pain responsivity