Chronic PainEarly Phase 1NCT05014126
Online "Pain, Stress & Emotions" Class in Chronic Pain
A Early Phase 1 study testing Pain, Stress and Emotions in people with Chronic Pain, run by Stanford University at 1 site in United States.
Trial summary
Members with chronic pain will be invited to participate in a 2-hour zoom-delivered pain psychology class entitled "Pain, Stress, \& Emotions". Surveys are completed at baseline (prior to the online class), a satisfaction survey is completed after the class, and post-treatment surveys completed 2, 4, 8, and 12 1weeks… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain, Stress and Emotions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 20 Mar 2022
- Phase
- Early Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain condition (pain > 3 months)
- Access to the internet
- English fluency
Who cannot join
- Ongoing legal action or disability claim
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online "Pain, Stress & Emotions" Class in Chronic Pain: Single-arm Efficacy Test
Members with chronic pain will be invited to participate in a 2-hour zoom-delivered pain psychology class entitled "Pain, Stress, \& Emotions". Surveys are completed at baseline (prior to the online class), a satisfaction survey is completed after the class, and post-treatment surveys completed 2, 4, 8, and 12 1weeks after class attendance.
- Conditions
- Chronic Pain
- Being tested
- Pain, Stress and Emotions
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain, Stress and EmotionsBehavioural
2-hour, zoom-delivered, group intervention focused on teaching patients how pain is processed in their brain and learning about the role of psychosocial factors in their pain conditions.
| Study group | Role | What they receive |
|---|---|---|
| Pain, Stress, & Emotions Class | Experimental | No active or placebo comparator will be used. This is a single-arm study design. Receives: Behavioral: Pain, Stress and Emotions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity NRS
Self-reported pain intensity rating
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Secondary outcomes (11)
Patient-Reported Outcomes Measurement Information System: Pain Interference short form 6a
self-reported pain interference levels
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Depression 6a
self-reported depression
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Anxiety 6a
self-reported anxiety
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Physical Function 8b
self-reported physical functioning
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Sleep Disturbance 6a
self-reported sleep disturbance
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: social isolation 6a
self-reported social isolation
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: fatigue 6a
self-reported fatigue
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: anger 5a
self-reported anger
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Ambivalence over Emotional Expression (AEQ)
self-reported ambivalence levels about emotional expression
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Emotion-Approach Coping
8-item emotion approach coping scale
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Pain Bothersomeness
single-item assessing self-reported levels of pain bothersomeness
Measured: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start20 Aug 2021
- Primary completion15 Jan 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uncontrolled, prospective, single arm, pre-post intervention study
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisa Ziadni, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014126
- Sponsor's protocol ID
- StanfordClass
- Status last verified
- Nov 2024
- First submitted
- 12 Aug 2021
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmes HJ, Thakur ER, Carty JN, Ziadni MS, Doherty HK, Lockhart NA, Schubiner H, Lumley MA. Ambivalence over emotional expression and perceived social constraints as moderators of relaxation training and emotional awareness and expression training for irritable bowel syndrome. Gen Hosp Psychiatry. 2018 Jul-Aug;53:38-43. doi: 10.1016/j.genhosppsych.2018.05.002. Epub 2018 May 3.
PubMed 29751205Carty JN, Ziadni MS, Holmes HJ, Tomakowsky J, Peters K, Schubiner H, Lumley MA. The Effects of a Life Stress Emotional Awareness and Expression Interview for Women with Chronic Urogenital Pain: A Randomized Controlled Trial. Pain Med. 2019 Jul 1;20(7):1321-1329. doi: 10.1093/pm/pny182.
PubMed 30252113Ziadni MS, Carty JN, Doherty HK, Porcerelli JH, Rapport LJ, Schubiner H, Lumley MA. A life-stress, emotional awareness, and expression interview for primary care patients with medically unexplained symptoms: A randomized controlled trial. Health Psychol. 2018 Mar;37(3):282-290. doi: 10.1037/hea0000566. Epub 2017 Nov 20.
PubMed 29154608Thakur ER, Holmes HJ, Lockhart NA, Carty JN, Ziadni MS, Doherty HK, Lackner JM, Schubiner H, Lumley MA. Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12):10.1111/nmo.13143. doi: 10.1111/nmo.13143. Epub 2017 Jun 22.
PubMed 28643436Ziadni MS, Sturgeon JA, Lumley MA. "Pain, Stress, and Emotions": Uncontrolled trial of a single-session, telehealth, emotional awareness and expression therapy class for patients with chronic pain. Front Pain Res (Lausanne). 2022 Nov 18;3:1028561. doi: 10.3389/fpain.2022.1028561. eCollection 2022.
PubMed 36466215
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online "Pain, Stress & Emotions" Class in Chronic Pain: Single-arm Efficacy Test
- ClinicalTrials.gov ID
- NCT05014126
- Acronym / sponsor ID
- StanfordClass
- Conditions
- Chronic Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 20 Aug 2021 (actual)
- 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.
Members with chronic pain will be invited to participate in a 2-hour zoom-delivered pain psychology class entitled "Pain, Stress, \& Emotions". Surveys are completed at baseline (prior to the online class), a satisfaction survey is completed after the class, and post-treatment surveys completed 2, 4, 8, and 12 1weeks after class attendance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled, prospective, single arm, pre-post intervention study
| Arm | Type | Receives |
|---|---|---|
| Pain, Stress, & Emotions Class | Experimental | Behavioral: Pain, Stress and EmotionsNo active or placebo comparator will be used. This is a single-arm study design. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic pain condition (pain > 3 months)
- Access to the internet
- English fluency
Key exclusion criteria (2 listed)
- Ongoing legal action or disability claim
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
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 |
|---|---|---|
| Pain, Stress and Emotions2-hour, zoom-delivered, group intervention focused on teaching patients how pain is processed in their brain and learning about the role of psychosocial factors in their pain conditions. | Behavioural | Pain, Stress, & Emotions Class |
Primary outcome
Pain Intensity NRS
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Self-reported pain intensity rating
11 secondary outcomes
Patient-Reported Outcomes Measurement Information System: Pain Interference short form 6a
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Depression 6a
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Anxiety 6a
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Physical Function 8b
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Sleep Disturbance 6a
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: social isolation 6a
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: fatigue 6a
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: anger 5a
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Ambivalence over Emotional Expression (AEQ)
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Emotion-Approach Coping
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Pain Bothersomeness
Time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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 5 Nov 2024.
- Background: PubMed 29751205Holmes HJ, Thakur ER, Carty JN, Ziadni MS, Doherty HK, Lockhart NA, Schubiner H, Lumley MA. Ambivalence over emotional expression and perceived social constraints as moderators of relaxation training and emotional awareness and expression training for irritable bowel syndrome. Gen Hosp Psychiatry. 2018 Jul-Aug;53:38-43. doi: 10.1016/j.genhosppsych.2018.05.002. Epub 2018 May 3.
- Background: PubMed 30252113Carty JN, Ziadni MS, Holmes HJ, Tomakowsky J, Peters K, Schubiner H, Lumley MA. The Effects of a Life Stress Emotional Awareness and Expression Interview for Women with Chronic Urogenital Pain: A Randomized Controlled Trial. Pain Med. 2019 Jul 1;20(7):1321-1329. doi: 10.1093/pm/pny182.
- Background: PubMed 29154608Ziadni MS, Carty JN, Doherty HK, Porcerelli JH, Rapport LJ, Schubiner H, Lumley MA. A life-stress, emotional awareness, and expression interview for primary care patients with medically unexplained symptoms: A randomized controlled trial. Health Psychol. 2018 Mar;37(3):282-290. doi: 10.1037/hea0000566. Epub 2017 Nov 20.
- Background: PubMed 28643436Thakur ER, Holmes HJ, Lockhart NA, Carty JN, Ziadni MS, Doherty HK, Lackner JM, Schubiner H, Lumley MA. Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12):10.1111/nmo.13143. doi: 10.1111/nmo.13143. Epub 2017 Jun 22.
- Derived from this study: PubMed 36466215Ziadni MS, Sturgeon JA, Lumley MA. "Pain, Stress, and Emotions": Uncontrolled trial of a single-session, telehealth, emotional awareness and expression therapy class for patients with chronic pain. Front Pain Res (Lausanne). 2022 Nov 18;3:1028561. doi: 10.3389/fpain.2022.1028561. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pain, Stress and Emotions in people with Chronic Pain, run by Stanford University 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 3 inclusion and 2 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 5 Nov 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Intensity NRS (time frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05014126, which also lists 5 linked publications.
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 5 Nov 2024.