Clinical trial NCT05513274: Heartache and Backache- An Online Intervention Addressing Emotional and Physical Pain
Official title: Randomized Clinical Trial of Pain Psychology/Neuroscience and Written Disclosure for Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain (Back / Neck)
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: The New School for Social Research
First posted: 2022-08-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a 2 by 2 factorial study
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Brief Pain Inventory Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)
timeFrame: Change from baseline to 5 weeks follow-up
Secondary outcomes:
measure: Pain Interference
timeFrame: Change from baseline to 5 weeks follow-up
measure: Patient-Reported Outcomes Measurement Information System: Depression short form 8b
timeFrame: Change from baseline to 5 weeks follow-up
measure: Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
timeFrame: Change from baseline to 5 weeks follow-up
measure: Patient-Reported Outcomes Measurement Information System: Fatigue
timeFrame: Change from baseline to 5 weeks follow-up
measure: Patient-Reported Outcomes Measurement Information System: Sleep
timeFrame: Change from baseline to 5 weeks follow-up
measure: Pain Catastrophizing Scale
timeFrame: Change from baseline to 5 weeks follow-up
measure: Pain attributions questionnaires
timeFrame: Change from baseline to 5 weeks follow-up
measure: Stigma Scale for Chronic Illnesses Short Form (SSCI-8)
timeFrame: Change from baseline to 5 weeks follow-up
measure: General Self Efficacy Scale
timeFrame: Change from baseline to 5 weeks follow-up
measure: Emotional approach coping scale
timeFrame: Change from baseline to 5 weeks follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: The New School for Social Research Department of Psychology
state: New York
Study officials:
affiliation: Wayne State University
name: Mark Lumley, PhD
role: STUDY_DIRECTOR
References: