Back to resultsA Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
Primary Purpose
Pain Catastrophizing, Primary Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pain Catastrophizing focused on measuring Cognitive behavioral therapy, Laboratory pain responsivity
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
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive behavioral therapy
Arm Description
Cognitive behavioral therapy aimed at reducing pain catastrophizing.
Outcomes
Primary Outcome Measures
Feasibility (as determined by attrition rate)
Acceptability - participants' views of the intervention's 1) appeal; 2) helpfulness; and 3) ease of participation
Change in pain catastrophizing
Change in menstrual pain level assessed via 11-point numeric rating scale (NRS)
Change in medication use (dosage and frequency of pain medication use)
Secondary Outcome Measures
Change in menstrual symptoms as assessed by the Menstrual Symptom Questionnaire (MSQ)
Change in anxiety as assessed by the Brief Symptom Inventory 18 (BSI-18)
Change in depression as assessed by the Brief Symptom Inventory 18 (BSI-18)
Change in somatization as assessed by the Brief Symptom Inventory 18 (BSI-18)
Change in temporal summation (TS)
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)
Full Information
NCT ID
NCT02640079
First Posted
December 17, 2015
Last Updated
April 11, 2018
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02640079
Brief Title
A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
Official Title
A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Catastrophizing, Primary Dysmenorrhea
Keywords
Cognitive behavioral therapy, Laboratory pain responsivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy aimed at reducing pain catastrophizing.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Primary Outcome Measure Information:
Title
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
Title
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)
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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 Pre-specified Outcome Measures:
Title
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)
Title
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Payne, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
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A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
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