Pain Catastrophizing, Primary Dysmenorrhea
Conditions
Keywords
Cognitive behavioral therapy, Laboratory pain responsivity
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.
Interventions
BEHAVIORALCognitive behavioral therapy
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 25 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
Other
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
Countries
United States
Outcome results
None listed