Optimizing Resilience In Orofacial Pain and Nociception (ORION)
Assessing the Efficacy of a Hope Intervention in Temporomandibular Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In recent years, there has been increasing interest in the contribution of positive psychological factors (e.g., optimism, pain acceptance, hope) to pain and pain-related coping. Although research supports the significance of these resilience factors in pain adaptation, psychological interventions based upon bolstering resilience have received far less attention. Emerging evidence supports the role of hope in psychosocial adjustment and enhancement of adaptive pain coping skills. Hope is considered to be a positive motivational state consisting of one's belief in their ability to generate routes to achieve goals (pathways) and initiation towards attaining these goals (agency). In the context of pain, increasing hope may promote augmentation of personal strengths to enhance development of meaningful goal pursuits and foster resilient outcomes. Enhancement of hopeful thinking and behavior may ultimately lead to the minimization of losses that are often associated with chronic pain. This experience may be also reflected physiologically, as increasing hope may confer biological benefits (e.g., decreased inflammation). Although hope-based interventions have been successfully applied in other clinical conditions (i.e., cancer), their utility in chronic pain disorders has not been examined.
To examine the effectiveness of this approach, a two-arm randomized trial will be conducted with individuals who have TMD. In Study Arm 1, participants will receive hope-based therapy. In Study Arm 2, participants will receive pain education. Participants will attend 5 sessions over a period of 5 weeks. Two of these sessions will involve quantitative sensory pain testing; three sessions will include delivery of the treatment intervention. Pain outcomes will be measured at pre- and post-treatment.
Aims:
- Examine the degree to which state and trait levels of hope are predictive of clinical pain, disability, affective distress, and experimental pain.
- Investigate the effects of a hope intervention, as compared to an education control group, on clinical and experimental pain in individuals with TMD.
- Identify psychosocial (e.g., hope, optimism, positive affect, catastrophizing), biological (e.g., inflammatory, endogenous opioid, neuroendocrine), and psychophysical factors associated with positive treatment response (i.e., reduction of clinical pain).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida, Pain Research and Intervention Center of Excellence (PRICE)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- participants between the ages of 18 and 65
- meets Research Diagnostic Criteria for TMD
- duration of pain is at least 3 months
- pain at least 15 days in the past month
- pain rated moderate to severe in intensity
Exclusion Criteria:
- uncontrolled hypertension
- current heart disease including heart failure
- kidney failure or currently undergoing dialysis
- current neurological conditions that could affect protocol safety or validity
- facial trauma or orofacial surgery within the last 6 months
- currently in orthodontic treatment
- currently pregnant and/or nursing
- use of narcotic analgesics (i.e., opioids) on a daily basis
- a primary pain condition other than TMD
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hope Therapy
Patients assigned to this arm will receive Hope Therapy in three individual intervention sessions.
Intervention will be administered by an experienced therapist.Training focuses on effective goal setting and augmenting hopeful thinking.
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Hope therapy is designed to address key components of hope theory through augmentation of hopeful thinking and enhancement of goal-directed activities.
Training focuses on effective goal setting, mobilization of internal resources to reach goals, identification of resilience factors to formulate hopeful thinking, and enhancing maintenance of future goal development.
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Other: Pain Education
Patients assigned to this arm will receive Pain Education in three individual intervention sessions.
Intervention will be administered by an experienced therapist.
Training will focus on understanding TMD-related pain and learning pain management techniques.
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Pain Education is aimed to increase understanding of TMD symptomatology and etiology, as well as provide general education on pain, lifestyle management, and effective pain communication methods.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in state hope on the 8-point Adult State Hope Scale at week 5
Time Frame: Baseline, Week 5
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The Adult State Hope Scale is a 6-item inventory used to assess goal-directed thinking at a given moment in time.
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Baseline, Week 5
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Change from baseline in clinical pain on the 0-100 Numerical Rating Scale at week 5
Time Frame: Baseline, Week 5
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0-100 Numerical Rating Scale used to assess clinical pain intensity.
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Baseline, Week 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in inflammatory, endogenous opioid, and neuroendocrine markers at week 5
Time Frame: Baseline, Week 5
|
Measurement of interleukin 6 (IL-6), beta-endorphin, cortisol, and alpha-amylase.
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Baseline, Week 5
|
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Change from baseline in optimism on the 5-point Life Orientation Test - Revised (LOT-R) at week 5
Time Frame: Baseline, Week 5
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The LOT-R is a 10-item measure assessing generalized positive outcome expectancies.
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Baseline, Week 5
|
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Change from baseline in positive and negative affect on the 5-point Positive and Negative Affect Schedule (PANAS) scale at week 5
Time Frame: Baseline, Week 5
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The PANAS is a 20-item scale that assesses positive affect (PA) and negative affect (NA).
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Baseline, Week 5
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Change from baseline in pain catastrophizing on the 5-point Pain Catastrophizing Scale (PCS) at week 5
Time Frame: Baseline, Week 5
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The PCS is a 13-item measure used to assess patient report of catastrophic thinking about pain
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Baseline, Week 5
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Change from baseline in sensory pain stimuli at week 5
Time Frame: Baseline, Week 5
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Measurement of heat pain threshold, heat pain tolerance, pressure pain threshold, cold pain threshold, and cold pain tolerance.
Threshold = when stimulus (in seconds) is first rated as "painful"; Tolerance = when stimulus (in seconds) is no longer able to be tolerated.
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Baseline, Week 5
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily J Bartley, Ph.D., University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201400260
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