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

December 4, 2023 updated by: Mark A. Lumley, Wayne State University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 48202
        • Recruiting
        • The New School for Social Research Department of Psychology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain Psychology Neuroscience+ Written Emotional Disclosure
Pain Neuroscience Education exercise followed by Written Emotional Disclosure
Behavioral: Pain Psychology Neuroscience + Written Emotional Disclosure
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.
Active Comparator: Pain Psychology Neuroscience + Healthy Habits Disclosure
Pain Neuroscience Education followed by Healthy Habits writing
Behavioral: Pain Psychology Neuroscience + Healthy Habits Disclosure
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.
Active Comparator: Health Behavior + Written Emotional Disclosure
Health behavior education followed by written emotional disclosure
Behavioral: Health Behavior Control + Written Emotional Disclosure
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.
Placebo Comparator: Health Behavior + Healthy Habits Disclosure
Health behavior intervention followed by healthy habits writing
Behavioral: Health Behavior Control + Healthy Habits Disclosure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline to 5 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Interference
Time Frame: Change from baseline to 5 weeks follow-up
PROMIS Pain Interference - Short Form 6b (6-20; higher values= greater pain interference)
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
Self-reported depression (8-40; higher values= greater severity of depression)
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
Self-reported anxiety (8-40; higher values= greater severity of anxiety)
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
Self reported fatigue (4-20; higher values= increased fatigue)
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
Self reported sleep (4-20; higher values= increased sleep difficulties)
Change from baseline to 5 weeks follow-up
Pain Catastrophizing Scale
Time Frame: Change from baseline to 5 weeks follow-up
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)
Change from baseline to 5 weeks follow-up
Pain attributions questionnaires
Time Frame: Change from baseline to 5 weeks follow-up
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])
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
Stigma Scale for Chronic Illnesses short form: A summed score of the 8 items will be computed (8-40m higher scored indicate greater stigma)
Change from baseline to 5 weeks follow-up
General Self Efficacy Scale
Time Frame: Change from baseline to 5 weeks follow-up
General Self Efficacy Scale: A summed score of the 10 items, will be computed (10-40) higher scored indicate greater self efficacy
Change from baseline to 5 weeks follow-up
Emotional approach coping scale
Time Frame: Change from baseline to 5 weeks follow-up
Emotional approach coping scale: A summed score of the 8 items, will be computed (8-32) higher scored indicate greater emotional approach coping
Change from baseline to 5 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

The New School for Social Research

Investigators

  • Study Director: Mark Lumley, PhD, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The New School

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

shared with Lauren Krulis- The New School for Social Research

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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