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

Primary Purpose

Chronic Pain (Back / Neck)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Psychology Neuroscience + Written Emotional Disclosure
Pain Psychology Neuroscience + Healthy Habits Disclosure
Health Behavior Control + Written Emotional Disclosure
Health Behavior Control + Healthy Habits Disclosure
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain (Back / Neck)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • The New School for Social Research Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Pain Psychology Neuroscience+ Written Emotional Disclosure

Pain Psychology Neuroscience + Healthy Habits Disclosure

Health Behavior + Written Emotional Disclosure

Health Behavior + Healthy Habits Disclosure

Arm Description

Pain Neuroscience Education exercise followed by Written Emotional Disclosure

Pain Neuroscience Education followed by Healthy Habits writing

Health behavior education followed by written emotional disclosure

Health behavior intervention followed by healthy habits writing

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Pain Interference
PROMIS Pain Interference - Short Form 6b (6-20; higher values= greater pain interference)
Patient-Reported Outcomes Measurement Information System: Depression short form 8b
Self-reported depression (8-40; higher values= greater severity of depression)
Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
Self-reported anxiety (8-40; higher values= greater severity of anxiety)
Patient-Reported Outcomes Measurement Information System: Fatigue
Self reported fatigue (4-20; higher values= increased fatigue)
Patient-Reported Outcomes Measurement Information System: Sleep
Self reported sleep (4-20; higher values= increased sleep difficulties)
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)
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])
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)
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
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

Full Information

First Posted
August 22, 2022
Last Updated
January 29, 2023
Sponsor
Wayne State University
Collaborators
The New School for Social Research
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1. Study Identification

Unique Protocol Identification Number
NCT05513274
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
The New School for Social Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain (Back / Neck)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
This is a 2 by 2 factorial study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Both patient and research assistant interviewer will be blinded to condition assignment during the baseline, intervention and follow up assessment.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Psychology Neuroscience+ Written Emotional Disclosure
Arm Type
Experimental
Arm Description
Pain Neuroscience Education exercise followed by Written Emotional Disclosure
Arm Title
Pain Psychology Neuroscience + Healthy Habits Disclosure
Arm Type
Active Comparator
Arm Description
Pain Neuroscience Education followed by Healthy Habits writing
Arm Title
Health Behavior + Written Emotional Disclosure
Arm Type
Active Comparator
Arm Description
Health behavior education followed by written emotional disclosure
Arm Title
Health Behavior + Healthy Habits Disclosure
Arm Type
Placebo Comparator
Arm Description
Health behavior intervention followed by healthy habits writing
Intervention Type
Behavioral
Intervention Name(s)
Pain Psychology Neuroscience + Written Emotional Disclosure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pain Psychology Neuroscience + Healthy Habits Disclosure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Behavior Control + Written Emotional Disclosure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Behavior Control + Healthy Habits Disclosure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Inventory Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)
Description
Pain severity scale (0 - 10; higher values = greater pain severity)
Time Frame
Change from baseline to 5 weeks follow-up
Secondary Outcome Measure Information:
Title
Pain Interference
Description
PROMIS Pain Interference - Short Form 6b (6-20; higher values= greater pain interference)
Time Frame
Change from baseline to 5 weeks follow-up
Title
Patient-Reported Outcomes Measurement Information System: Depression short form 8b
Description
Self-reported depression (8-40; higher values= greater severity of depression)
Time Frame
Change from baseline to 5 weeks follow-up
Title
Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
Description
Self-reported anxiety (8-40; higher values= greater severity of anxiety)
Time Frame
Change from baseline to 5 weeks follow-up
Title
Patient-Reported Outcomes Measurement Information System: Fatigue
Description
Self reported fatigue (4-20; higher values= increased fatigue)
Time Frame
Change from baseline to 5 weeks follow-up
Title
Patient-Reported Outcomes Measurement Information System: Sleep
Description
Self reported sleep (4-20; higher values= increased sleep difficulties)
Time Frame
Change from baseline to 5 weeks follow-up
Title
Pain Catastrophizing Scale
Description
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)
Time Frame
Change from baseline to 5 weeks follow-up
Title
Pain attributions questionnaires
Description
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])
Time Frame
Change from baseline to 5 weeks follow-up
Title
Stigma Scale for Chronic Illnesses Short Form (SSCI-8)
Description
Stigma Scale for Chronic Illnesses short form: A summed score of the 8 items will be computed (8-40m higher scored indicate greater stigma)
Time Frame
Change from baseline to 5 weeks follow-up
Title
General Self Efficacy Scale
Description
General Self Efficacy Scale: A summed score of the 10 items, will be computed (10-40) higher scored indicate greater self efficacy
Time Frame
Change from baseline to 5 weeks follow-up
Title
Emotional approach coping scale
Description
Emotional approach coping scale: A summed score of the 8 items, will be computed (8-32) higher scored indicate greater emotional approach coping
Time Frame
Change from baseline to 5 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Krulis, MA
Phone
917-297-9428
Email
krull588@newschool.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Lumley, PhD
Organizational Affiliation
Wayne State University
Official's Role
Study Director
Facility Information:
Facility Name
The New School for Social Research Department of Psychology
City
New York
State/Province
New York
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Krulis, MA
Phone
917-297-9428
Email
Krull588@newschool.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
shared with Lauren Krulis- The New School for Social Research

Learn more about this trial

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

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