A Skills-Based Program Delivered Via Secure Live Video to Patients With Acute Musculoskeletal Trauma

Study Overview
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Brief Summary
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The aims of this study are to test a manualized mind body skills-building program aimed at preventing the development of chronic pain and disability following acute musculoskeletal injury in at-risk patients.

Detailed Description
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This is a pilot randomized feasibility trial of the mind body program Toolkit for Optimal Recovery versus usual medical care. The Toolkit is delivered via secure live video to patients at risk for chronic pain, at 1-2 months after injury. The primary aim of this study is to determine the feasibility and acceptability of the program, randomization, procedures and outcome measures. Secondarily, we report means and standard deviation and explore change in quantitative outcomes in the Toolkit compared to usual care.

Official Title
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A Randomized Controlled Trial Testing a Skills-Based Program Called A Toolkit for Optimal Recovery Delivered Via Secure Live Video Compared to Standard Medical Care in Patients With Acute Musculoskeletal Injuries

Conditions
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Musculoskeletal Injury, Fracture

Intervention / Treatment
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* Behavioral: The Toolkit for Optimal Recovery after Injury


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of musculoskeletal injury in the past 1-2 months 18 years of age or older English fluency and literacy PCS OR, PASS score above median split Exclusion Criteria: Major medical comorbidity expected to worsen in the next 6 months Comorbid chronic pain condition Antidepressant medication change in the past 6 months Secondary gains such as litigations or workers compensation procedures Diagnosis of psychosis, bipolar disorder or active substance dependence (by self report) Unwilling or unable to use videoconferencing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toolkit for Optimal Recovery after Injury<br>The Toolkit for Optimal Recovery after Injury (ToR) is a mind body skills based program delivered individually via secure live video. The format is a 4-week program with weekly meetings and a focus on teaching skills to optimize recovery and prevent chronic pain and disability. | Behavioral: The Toolkit for Optimal Recovery after Injury<br>* The Toolkit for Optimal Recovery after Injury (ToR) is a skills based mind body program that was designed to prevent the development of chronic pain and disability following an acute musculoskeletal injury (e.g., fracture). The program has 4 sessions and it is delivered via live video. Patients learn myth about recovery after injury, false and real pain alarms, the fear avoidance model and how to prevent the disability spiral, mindfulness based exercises and activity pacing.<br>* Other names: ToR;|
| No Intervention: Usual Care<br>The Usual Care (UC) group will continue with their current medical care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment | We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized | 0 Weeks | 
| Satisfaction with ToR | 3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician. | 4 weeks; 3 months | 
| Acceptability | We will report number of patients who finished ToR and UC and completed post-test from those who started the study (were randomized); We will also report number of participants who provided 3 months follow up | 4 weeks; 3 months | 
| Feasibility of outcome measures | We will report number of missing items and calculate reliability of outcome measures | 0 weeks; 4 weeks; 3 months | 
| Adherence to ToR | We will report number of participants who completed at least 3 out of 4 ToR sessions | 4 weeks. | 
| Adherence to homework | determined by number of homework logs returned | 4 weeks | 
| Therapist adherence survey | Items assessing whether the therapist taught each of the skills included in each of the 4 sessions | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Catastrophizing | Pain Catastrophizing Scale (PCS); items are summed to generate a total score; scores range from 0 to 52; higher scores indicate greater pain catastrophizing | 0 Weeks, 4 Weeks, 3 Months | 
| Pain Anxiety | Pain Anxiety Symptom Scale (PASS); items are summed to generate a total score; scores range from 0-100; higher sores indicate greater pain anxiety | 0 Weeks, 4 Weeks, 3 Months | 
| Depression | Center for Epidemiologic Studies Depression Scale (CESD); items are summed to generate a total score; scores range from 0 to 60; higher scores indicate greater depressive symptomatology | 0 Weeks, 4 Weeks, 3 Months | 
| Post Traumatic Stress Disorder | Post Traumatic Stress Disorder Checklist (PCL); items are summed to generate a total score; scores range from 17 to 85; higher scores indicate greater post traumatic stress | 0 Weeks, 4 Weeks, 3 Months | 
| Pain intensity | Numerical rating scale assessing pain form 0 to 10 | 0 Weeks, 4 Weeks, 3 Months | 
| Physical Function | Short Musculoskeletal Function Assessment (SMFA); two scores are generated by summing items 1-34 for Function Index and 35-46 for Bothersome Index; | 0 Weeks, 4 Weeks, 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatry, Psychology, Psychosocial, Mind-Body