Clinical trial NCT02640079: A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
Official title: A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Catastrophizing
Primary Dysmenorrhea
Keywords: Cognitive behavioral therapy
Laboratory pain responsivity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 24
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Feasibility (as determined by attrition rate)
timeFrame: After each cohort completes their 5 group CBT sessions; 1 week after the 5th and final CBT session in each cohort
measure: Acceptability - participants' views of the intervention's 1) appeal; 2) helpfulness; and 3) ease of participation
timeFrame: 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)
measure: Change in pain catastrophizing
timeFrame: 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
measure: Change in menstrual pain level assessed via 11-point numeric rating scale (NRS)
timeFrame: 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
measure: Change in medication use (dosage and frequency of pain medication use)
timeFrame: 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:
measure: Change in menstrual symptoms as assessed by the Menstrual Symptom Questionnaire (MSQ)
timeFrame: 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
measure: Change in anxiety as assessed by the Brief Symptom Inventory 18 (BSI-18)
timeFrame: 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
measure: Change in depression as assessed by the Brief Symptom Inventory 18 (BSI-18)
timeFrame: 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
measure: Change in somatization as assessed by the Brief Symptom Inventory 18 (BSI-18)
timeFrame: 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
measure: Change in temporal summation (TS)
timeFrame: Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation
measure: 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)
timeFrame: Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation
Other outcomes:
measure: Galvanic Skin Response (GSR)
timeFrame: 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)
measure: Heart Rate Variability (HRV)
timeFrame: 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)
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Laura A Payne, PhD
role: PRINCIPAL_INVESTIGATOR
References: