Chronic Pain (Back / Neck)NCT05513274
Heartache and Backache- An Online Intervention Addressing Emotional and Physical Pain
A study testing Pain Psychology Neuroscience + Written Emotional Disclosure and Pain Psychology Neuroscience + Healthy Habits Disclosure in people with Chronic Pain (Back / Neck), run by Wayne State University at 1 site in United States.
Trial summary
This study is designed to determine if a brief educational program and a written emotional disclosure task can improve chronic back/neck pain-related outcomes and change pain beliefs and other processes in individuals with chronic back pain. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain (Back / Neck)
- What is being tested?
- Pain Psychology Neuroscience + Written Emotional Disclosure and Pain Psychology Neuroscience + Healthy Habits Disclosure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 30 Dec 2024
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- Chronic musculoskeletal back or neck pain for greater than 1 year as primary symptom complaint
- Participants living in western countries USA, UK and Australia
- Have access to a computer or smartphone
Who cannot join
- Presence of serious disease or impairment (cancer, systemic infection, serious vision impairment)
- Clear evidence of significant structural damage likely causing their pain (eg, vertebral compression fracture);
- Being considered for interventional spine procedures (eg, steroidal injections) or surgery;
- Leg or arm pain more severe than back or neck pain
- Rheumatoid arthritis
- Fibromyalgia
- Active psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
The New School for Social Research Department of Psychology
New York, New York, 48202
About this study
Official title: Randomized Clinical Trial of Pain Psychology/Neuroscience and Written Disclosure for Chronic Pain
This study is designed to determine if a brief educational program and a written emotional disclosure task can improve chronic back/neck pain-related outcomes and change pain beliefs and other processes in individuals with chronic back pain.
Individuals will be randomly assigned to an experimental condition (pain and affect neuroscience education) or a control condition (general health activities questionnaire), and then subsequently randomized to a second experimental condition (written emotional disclosure) or a control condition (writing about healthy habits).
Analyses will examine the main and interactive effects of the pain and affect neuroscience education and written emotional disclosure on improved pain-related outcomes at 1-month follow-up. Participants in both the experimental conditions are expected to show more improvement on pain severity, pain interference, psychological distress and psychological attitudes toward pain at follow-up, relative to participants in the control groups.
Read the detailed description
This study will recruit adults with chronic back and neck pain. Participants will be adults between the aged of 18 and 75. Participants will be excluded if they have the presence of serious disease or impairment (cancer, systemic infection, serious vision impairment), if there is clear evidence of significant structural damage likely causing their pain (eg, vertebral compression fracture); being considered for interventional spine procedures (eg, steroidal injections) or surgery; leg or arm pain more severe than back or neck pain; if they have been diagnosed with fibromyalgia, rheumatoid arthritis or have active psychosis. Participants will be allowed to engage in this study regardless of current medication use or engagement in other treatment.
Participants who are interested in participating will complete a brief online zoom interview to determine eligibility and will be provided with basic information about the study. Once eligibility has been determined, consent form and, baseline measures will be sent out and completed online.
Participants will be emailed confirming they are still interested in participating. Once they reply, they will complete baseline measures (on-line) and then be randomized 1:1 to the pain psychology and affect neuroscience education intervention or the health behavior intervention. For the pain neuroscience education, participants will complete a 15 to 20-minute on-line exercise that inquires about 5 domains: the degree of central sensitization symptoms, catastrophizing , personality factors, stressors that triggered or exacerbated the pain, and adverse childhood experiences. The health behavior control intervention participants will engage in a 15 to 20-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections.
Once they have completed the first intervention participants will be randomly assigned to the written emotional disclosure task or the healthy behavior-writing task. For the written emotional disclosure task participants will be asked to write for 20 minutes about their very deepest thoughts and feelings about the most traumatic experience of their lives. There will be a 10-minute break and when they return participants will be asked to write again for 20 minutes about how you have come to understand what happened and how you have changed because of the event. The healthy behavior writing task will include writing for 20 minutes a letter to a person of their choosing describing healthy behaviors, a 10 minute break and a second 20 minute writing task describing a time when they performed a healthy behaviors.
Follow-up measures will be administered 5 weeks after the intervention. There will be clinical outcomes assessed that reflect changes in pain severity, pain-related interference and pain catastrophizing. Psychological outcomes that reflect changes in symptoms for depression, anxiety, fatigue and sleep. Finally there will be attitudinal outcomes in stigma around chronic pain and patients' attributions about the role of psychological and brain-based factors in pain and self efficacy.
- Conditions
- Chronic Pain (Back / Neck)
- Being tested
- Pain Psychology Neuroscience + Written Emotional Disclosure, Pain Psychology Neuroscience + Healthy Habits Disclosure, Health Behavior Control + Written Emotional Disclosure, Health Behavior Control + Healthy Habits Disclosure
- 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 Psychology Neuroscience + Written Emotional DisclosureBehavioural
A 15 to 20-minute exercise which they examine variables in themselves that suggest that their pain is driven by central nervous system processes. Participants will then write for 20 minutes about their very deepest thoughts and feelings about the most traumatic experience of their lives. A 10-minute break followed by writing again for 20 minutes about how they have come to understand what happened and how they have changed because of the event.
Pain Psychology Neuroscience + Healthy Habits DisclosureBehavioural
This condition is a 15 to 20-minute exercise that patients complete in which they examine variables in themselves that suggest that their pain is driven by central nervous system processes in their brains. Followed by writing for 20 minutes a letter to a person of their choosing describing healthy behaviors, a 10 minute break and then a second 20 minute writing task describing a time when they performed a healthy behavior.
Health Behavior Control + Written Emotional DisclosureBehavioural
This 15 to 20-minute exercise that relates to healthy behaviors. Participants are asked to examine various domains of their own health behavior as engaged in over the past 24 hours (e.g., nutrition, sleep, exercise, hygiene, social connections). Participants will then write for 20 minutes about their very deepest thoughts and feelings about the most traumatic experience of their lives. A 10-minute break followed by writing again for 20 minutes about how they have come to understand what happened and how they have changed because of the event.
Health Behavior Control + Healthy Habits DisclosureBehavioural
This 15 to 20-minute exercise that relates to healthy behaviors. Participants are asked to examine various domains of their own health behavior as engaged in over the past 24 hours (e.g., nutrition, sleep, exercise, hygiene, social connections). Followed by writing for 20 minutes a letter to a person of their choosing describing healthy behaviors, a 10 minute break and then a second 20 minute writing task describing a time when they performed a healthy behavior.
| Study group | Role | What they receive |
|---|---|---|
| Pain Psychology Neuroscience+ Written Emotional Disclosure | Experimental | Pain Neuroscience Education exercise followed by Written Emotional Disclosure Receives: Behavioral: Pain Psychology Neuroscience + Written Emotional Disclosure |
| Pain Psychology Neuroscience + Healthy Habits Disclosure | Active comparator | Pain Neuroscience Education followed by Healthy Habits writing Receives: Behavioral: Pain Psychology Neuroscience + Healthy Habits Disclosure |
| Health Behavior + Written Emotional Disclosure | Active comparator | Health behavior education followed by written emotional disclosure Receives: Behavioral: Health Behavior Control + Written Emotional Disclosure |
| Health Behavior + Healthy Habits Disclosure | Placebo comparator | Health behavior intervention followed by healthy habits writing Receives: Behavioral: Health Behavior Control + Healthy Habits Disclosure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)
Pain severity scale (0 - 10; higher values = greater pain severity)
Measured: Change from baseline to 5 weeks follow-up
Secondary outcomes (10)
Pain Interference
PROMIS Pain Interference - Short Form 6b (6-20; higher values= greater pain interference)
Measured: Change from baseline to 5 weeks follow-up
Patient-Reported Outcomes Measurement Information System: Depression short form 8b
Self-reported depression (8-40; higher values= greater severity of depression)
Measured: Change from baseline to 5 weeks follow-up
Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
Self-reported anxiety (8-40; higher values= greater severity of anxiety)
Measured: Change from baseline to 5 weeks follow-up
Patient-Reported Outcomes Measurement Information System: Fatigue
Self reported fatigue (4-20; higher values= increased fatigue)
Measured: Change from baseline to 5 weeks follow-up
Patient-Reported Outcomes Measurement Information System: Sleep
Self reported sleep (4-20; higher values= increased sleep difficulties)
Measured: Change from baseline to 5 weeks follow-up
Pain Catastrophizing Scale
Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 Catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)
Measured: Change from baseline to 5 weeks follow-up
Pain attributions questionnaires
The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based. Higher scores indicate a greater belief that pain is a brain-related [brain attribution] and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution])
Measured: Change from baseline to 5 weeks follow-up
Stigma Scale for Chronic Illnesses Short Form (SSCI-8)
Stigma Scale for Chronic Illnesses short form: A summed score of the 8 items will be computed (8-40m higher scored indicate greater stigma)
Measured: Change from baseline to 5 weeks follow-up
General Self Efficacy Scale
General Self Efficacy Scale: A summed score of the 10 items, will be computed (10-40) higher scored indicate greater self efficacy
Measured: Change from baseline to 5 weeks follow-up
Emotional approach coping scale
Emotional approach coping scale: A summed score of the 8 items, will be computed (8-32) higher scored indicate greater emotional approach coping
Measured: Change from baseline to 5 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start15 Dec 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain (Back / Neck)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Model description
- This is a 2 by 2 factorial study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- The New School for Social Research
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark Lumley, PhD, Study director, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513274
- Sponsor's protocol ID
- The New School
- Status last verified
- Jul 2025
- First submitted
- 22 Aug 2022
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: shared with Lauren Krulis- The New School for Social Research
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Pain Psychology/Neuroscience and Written Disclosure for Chronic Pain
- ClinicalTrials.gov ID
- NCT05513274
- Acronym / sponsor ID
- The New School
- Conditions
- Chronic Pain (Back / Neck)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- The New School for Social Research
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 24 Aug 2022 (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.
This study is designed to determine if a brief educational program and a written emotional disclosure task can improve chronic back/neck pain-related outcomes and change pain beliefs and other processes in individuals with chronic back pain.
Individuals will be randomly assigned to an experimental condition (pain and affect neuroscience education) or a control condition (general health activities questionnaire), and then subsequently randomized to a second experimental condition (written emotional disclosure) or a control condition (writing about healthy habits).
Analyses will examine the main and interactive effects of the pain and affect neuroscience education and written emotional disclosure on improved pain-related outcomes at 1-month follow-up. Participants in both the experimental conditions are expected to show more improvement on pain severity, pain interference, psychological distress and psychological attitudes toward pain at follow-up, relative to participants in the control groups.
Detailed description
This study will recruit adults with chronic back and neck pain. Participants will be adults between the aged of 18 and 75. Participants will be excluded if they have the presence of serious disease or impairment (cancer, systemic infection, serious vision impairment), if there is clear evidence of significant structural damage likely causing their pain (eg, vertebral compression fracture); being considered for interventional spine procedures (eg, steroidal injections) or surgery; leg or arm pain more severe than back or neck pain; if they have been diagnosed with fibromyalgia, rheumatoid arthritis or have active psychosis. Participants will be allowed to engage in this study regardless of current medication use or engagement in other treatment.
Participants who are interested in participating will complete a brief online zoom interview to determine eligibility and will be provided with basic information about the study. Once eligibility has been determined, consent form and, baseline measures will be sent out and completed online.
Participants will be emailed confirming they are still interested in participating. Once they reply, they will complete baseline measures (on-line) and then be randomized 1:1 to the pain psychology and affect neuroscience education intervention or the health behavior intervention. For the pain neuroscience education, participants will complete a 15 to 20-minute on-line exercise that inquires about 5 domains: the degree of central sensitization symptoms, catastrophizing , personality factors, stressors that triggered or exacerbated the pain, and adverse childhood experiences. The health behavior control intervention participants will engage in a 15 to 20-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections.
Once they have completed the first intervention participants will be randomly assigned to the written emotional disclosure task or the healthy behavior-writing task. For the written emotional disclosure task participants will be asked to write for 20 minutes about their very deepest thoughts and feelings about the most traumatic experience of their lives. There will be a 10-minute break and when they return participants will be asked to write again for 20 minutes about how you have come to understand what happened and how you have changed because of the event. The healthy behavior writing task will include writing for 20 minutes a letter to a person of their choosing describing healthy behaviors, a 10 minute break and a second 20 minute writing task describing a time when they performed a healthy behaviors.
Follow-up measures will be administered 5 weeks after the intervention. There will be clinical outcomes assessed that reflect changes in pain severity, pain-related interference and pain catastrophizing. Psychological outcomes that reflect changes in symptoms for depression, anxiety, fatigue and sleep. Finally there will be attitudinal outcomes in stigma around chronic pain and patients' attributions about the role of psychological and brain-based factors in pain and self efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a 2 by 2 factorial study
| Arm | Type | Receives |
|---|---|---|
| Pain Psychology Neuroscience+ Written Emotional Disclosure | Experimental | Behavioral: Pain Psychology Neuroscience + Written Emotional DisclosurePain Neuroscience Education exercise followed by Written Emotional Disclosure |
| Pain Psychology Neuroscience + Healthy Habits Disclosure | Active comparator | Behavioral: Pain Psychology Neuroscience + Healthy Habits DisclosurePain Neuroscience Education followed by Healthy Habits writing |
| Health Behavior + Written Emotional Disclosure | Active comparator | Behavioral: Health Behavior Control + Written Emotional DisclosureHealth behavior education followed by written emotional disclosure |
| Health Behavior + Healthy Habits Disclosure | Placebo comparator | Behavioral: Health Behavior Control + Healthy Habits DisclosureHealth behavior intervention followed by healthy habits writing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Chronic musculoskeletal back or neck pain for greater than 1 year as primary symptom complaint
- Participants living in western countries USA, UK and Australia
- Have access to a computer or smartphone
Key exclusion criteria (7 listed)
- Presence of serious disease or impairment (cancer, systemic infection, serious vision impairment)
- Clear evidence of significant structural damage likely causing their pain (eg, vertebral compression fracture);
- Being considered for interventional spine procedures (eg, steroidal injections) or surgery;
- Leg or arm pain more severe than back or neck pain
- Rheumatoid arthritis
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 Psychology Neuroscience + Written Emotional DisclosureA 15 to 20-minute exercise which they examine variables in themselves that suggest that their pain is driven by central nervous system processes. Participants will then write for 20 minutes about their very deepest thoughts and feelings about the most traumatic experience of their lives. A 10-minute break followed by writing again for 20 minutes about how they have come to understand what happened and how they have changed because of the event. | Behavioural | Pain Psychology Neuroscience+ Written Emotional Disclosure |
| Pain Psychology Neuroscience + Healthy Habits DisclosureThis condition is a 15 to 20-minute exercise that patients complete in which they examine variables in themselves that suggest that their pain is driven by central nervous system processes in their brains. Followed by writing for 20 minutes a letter to a person of their choosing describing healthy behaviors, a 10 minute break and then a second 20 minute writing task describing a time when they performed a healthy behavior. | Behavioural | Pain Psychology Neuroscience + Healthy Habits Disclosure |
| Health Behavior Control + Written Emotional DisclosureThis 15 to 20-minute exercise that relates to healthy behaviors. Participants are asked to examine various domains of their own health behavior as engaged in over the past 24 hours (e.g., nutrition, sleep, exercise, hygiene, social connections). Participants will then write for 20 minutes about their very deepest thoughts and feelings about the most traumatic experience of their lives. A 10-minute break followed by writing again for 20 minutes about how they have come to understand what happened and how they have changed because of the event. | Behavioural | Health Behavior + Written Emotional Disclosure |
| Health Behavior Control + Healthy Habits DisclosureThis 15 to 20-minute exercise that relates to healthy behaviors. Participants are asked to examine various domains of their own health behavior as engaged in over the past 24 hours (e.g., nutrition, sleep, exercise, hygiene, social connections). Followed by writing for 20 minutes a letter to a person of their choosing describing healthy behaviors, a 10 minute break and then a second 20 minute writing task describing a time when they performed a healthy behavior. | Behavioural | Health Behavior + Healthy Habits Disclosure |
Primary outcome
Brief Pain Inventory Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)
Time frame: Change from baseline to 5 weeks follow-up
Pain severity scale (0 - 10; higher values = greater pain severity)
10 secondary outcomes
Pain Interference
Time frame: Change from baseline to 5 weeks follow-up
Patient-Reported Outcomes Measurement Information System: Depression short form 8b
Time frame: Change from baseline to 5 weeks follow-up
Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
Time frame: Change from baseline to 5 weeks follow-up
Patient-Reported Outcomes Measurement Information System: Fatigue
Time frame: Change from baseline to 5 weeks follow-up
Patient-Reported Outcomes Measurement Information System: Sleep
Time frame: Change from baseline to 5 weeks follow-up
Pain Catastrophizing Scale
Time frame: Change from baseline to 5 weeks follow-up
Pain attributions questionnaires
Time frame: Change from baseline to 5 weeks follow-up
Stigma Scale for Chronic Illnesses Short Form (SSCI-8)
Time frame: Change from baseline to 5 weeks follow-up
General Self Efficacy Scale
Time frame: Change from baseline to 5 weeks follow-up
Emotional approach coping scale
Time frame: Change from baseline to 5 weeks 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 16 Jul 2025.
- Individual participant dataSharing planned: No. shared with Lauren Krulis- The New School for Social Research
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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.
Mark Lumley, PhD study director
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Psychology Neuroscience + Written Emotional Disclosure and Pain Psychology Neuroscience + Healthy Habits Disclosure in people with Chronic Pain (Back / Neck), run by Wayne State 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 4 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 16 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
Brief Pain Inventory Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity) (time frame: Change from baseline to 5 weeks follow-up). 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 16 Jul 2025.