A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cognitive behavioral therapy Cognitive behavioral therapy aimed at reducing pain catastrophizing. |
Behavioral: Cognitive behavioral therapy
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Other Outcome Measures
- 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)]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
- Principal Investigator: Laura A Payne, PhD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15-001761