Heartache and Backache- An Online Intervention Addressing Emotional and Physical Pain

Wayne State University

Status: Completed

Conditions: Chronic Pain (Back / Neck)

Treatments: Behavioral: Health Behavior Control + Healthy Habits Disclosure; Behavioral: Pain Psychology Neuroscience + Written Emotional Disclosure; Behavioral: Health Behavior Control + Written Emotional Disclosure; Behavioral: Pain Psychology Neuroscience + Healthy Habits Disclosure

Study type: Interventional

Funder types: Other

Identifiers

NCT05513274

The New School

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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107 participants in 4 patient groups, including a placebo group

Pain Psychology Neuroscience+ Written Emotional Disclosure

Experimental group

Description:

Pain Neuroscience Education exercise followed by Written Emotional Disclosure

Treatment:

Behavioral: Pain Psychology Neuroscience + Written Emotional Disclosure

Pain Psychology Neuroscience + Healthy Habits Disclosure

Active Comparator group

Description:

Pain Neuroscience Education followed by Healthy Habits writing

Treatment:

Behavioral: Pain Psychology Neuroscience + Healthy Habits Disclosure

Health Behavior + Written Emotional Disclosure

Active Comparator group

Description:

Health behavior education followed by written emotional disclosure

Treatment:

Behavioral: Health Behavior Control + Written Emotional Disclosure

Health Behavior + Healthy Habits Disclosure

Placebo Comparator group

Description:

Health behavior intervention followed by healthy habits writing

Treatment:

Behavioral: Health Behavior Control + Healthy Habits Disclosure