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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Musculoskeletal Injury
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Adherence to ToR
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Ana-Maria Vranceanu, PhD
Clinical Psychologist
Massachusetts General Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adherence to ToR
Time Frame: 4 weeks.
We will report number of participants who completed at least 3 out of 4 ToR sessions
Satisfaction with ToR
Time Frame: 4 weeks; 3 months
3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.
Acceptability
Time Frame: 4 weeks; 3 months
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
Adherence to homework
Time Frame: 4 weeks
determined by number of homework logs returned
Therapist adherence survey
Time Frame: 4 weeks
Items assessing whether the therapist taught each of the skills included in each of the 4 sessions
Feasibility of recruitment
Time Frame: 0 Weeks
We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized
Feasibility of outcome measures
Time Frame: 0 weeks; 4 weeks; 3 months
We will report number of missing items and calculate reliability of outcome measures
Secondary Outcomes
- Pain Catastrophizing(0 Weeks, 4 Weeks, 3 Months)
- Post Traumatic Stress Disorder(0 Weeks, 4 Weeks, 3 Months)
- Physical Function(0 Weeks, 4 Weeks, 3 Months)
- Pain Anxiety(0 Weeks, 4 Weeks, 3 Months)
- Pain intensity(0 Weeks, 4 Weeks, 3 Months)
- Depression(0 Weeks, 4 Weeks, 3 Months)