Pain CatastrophizingNCT02640079
A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
A study testing Cognitive behavioral therapy in people with Pain Catastrophizing and Primary Dysmenorrhea, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years, women only
- Conditions the study is for
- Pain Catastrophizing, Primary Dysmenorrhea
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- Women only
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
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.
- Conditions
- Pain Catastrophizing, Primary Dysmenorrhea
- Being tested
- Cognitive behavioral therapy
- Keywords
- Cognitive behavioral therapy, Laboratory pain responsivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Cognitive behavioral therapy aimed at reducing pain catastrophizing. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (as determined by attrition rate)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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 (6)
Change in menstrual symptoms as assessed by the Menstrual Symptom Questionnaire (MSQ)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Assessed at pre- and post-intervention lab sessions, each of which will occur during the first 2 days of menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain CatastrophizingStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Payne, University of California, Los Angeles
- Investigators
- Laura A Payne, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640079
- Sponsor's protocol ID
- 15-001761
- Status last verified
- Apr 2018
- First submitted
- 17 Dec 2015
- Last updated
- 13 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT02640079
- Acronym / sponsor ID
- 15-001761
- Conditions
- Pain Catastrophizing, Primary Dysmenorrhea
- Keywords
- Cognitive behavioral therapy, Laboratory pain responsivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 28 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapyCognitive behavioral therapy aimed at reducing pain catastrophizing. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy | Behavioural | Cognitive behavioral therapy |
Primary outcome
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
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)
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
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
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A Payne, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Pain Catastrophizing and Primary Dysmenorrhea, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.