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

NCT05513274 | Completed

• 1 other identifier: The New School
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain (Back / Neck)

Outcome Measures

Primary Outcomes (1)

• 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)

  Change from baseline to 5 weeks follow-up

Secondary Outcomes (10)

• Pain Interference

  Change from baseline to 5 weeks follow-up

• Patient-Reported Outcomes Measurement Information System: Depression short form 8b

  Change from baseline to 5 weeks follow-up

• Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a

  Change from baseline to 5 weeks follow-up

• Patient-Reported Outcomes Measurement Information System: Fatigue

  Change from baseline to 5 weeks follow-up

• Patient-Reported Outcomes Measurement Information System: Sleep

  Change from baseline to 5 weeks follow-up

Study Arms (4)

Pain Psychology Neuroscience+ Written Emotional Disclosure

EXPERIMENTAL

Pain Neuroscience Education exercise followed by Written Emotional Disclosure

Behavioral: Pain Psychology Neuroscience + Written Emotional Disclosure

Pain Psychology Neuroscience + Healthy Habits Disclosure

ACTIVE COMPARATOR

Pain Neuroscience Education followed by Healthy Habits writing

Behavioral: Pain Psychology Neuroscience + Healthy Habits Disclosure

Health Behavior + Written Emotional Disclosure

ACTIVE COMPARATOR

Health behavior education followed by written emotional disclosure

Behavioral: Health Behavior Control + Written Emotional Disclosure

Health Behavior + Healthy Habits Disclosure

PLACEBO COMPARATOR

Health behavior intervention followed by healthy habits writing

Behavioral: Health Behavior Control + Healthy Habits Disclosure

Interventions

Pain Psychology Neuroscience + Written Emotional Disclosure BEHAVIORAL

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+ Written Emotional Disclosure

Pain Psychology Neuroscience + Healthy Habits Disclosure BEHAVIORAL

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.

Pain Psychology Neuroscience + Healthy Habits Disclosure

Health Behavior Control + Written Emotional Disclosure BEHAVIORAL

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 + Written Emotional Disclosure

Health Behavior Control + Healthy Habits Disclosure BEHAVIORAL

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.

Health Behavior + Healthy Habits Disclosure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• The New School for Social Research: collaborator

Study Sites (1)

The New School for Social Research Department of Psychology

New York, New York, 48202, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Lumley, PhD

  Wayne State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both patient and research assistant interviewer will be blinded to condition assignment during the baseline, intervention and follow up assessment.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: This is a 2 by 2 factorial study

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: December 15, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)