Clinical trial NCT03405610: A Skills-Based Program Delivered Via Secure Live Video to Patients With Acute Musculoskeletal Trauma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Injury
Fracture
Keywords: Psychiatry
Psychology
Psychosocial
Mind-Body
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: 0 Weeks
measure: Satisfaction with ToR
timeFrame: 4 weeks; 3 months
measure: Acceptability
timeFrame: 4 weeks; 3 months
measure: Feasibility of outcome measures
timeFrame: 0 weeks; 4 weeks; 3 months
measure: Adherence to ToR
timeFrame: 4 weeks.
measure: Adherence to homework
timeFrame: 4 weeks
measure: Therapist adherence survey
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Catastrophizing
timeFrame: 0 Weeks, 4 Weeks, 3 Months
measure: Pain Anxiety
timeFrame: 0 Weeks, 4 Weeks, 3 Months
measure: Depression
timeFrame: 0 Weeks, 4 Weeks, 3 Months
measure: Post Traumatic Stress Disorder
timeFrame: 0 Weeks, 4 Weeks, 3 Months
measure: Pain intensity
timeFrame: 0 Weeks, 4 Weeks, 3 Months
measure: Physical Function
timeFrame: 0 Weeks, 4 Weeks, 3 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vranceanu AM, Jacobs C, Lin A, Greenberg J, Funes CJ, Harris MB, Heng MM, Macklin EA, Ring D. Results of a feasibility randomized controlled trial (RCT) of the Toolkit for Optimal Recovery (TOR): a live video program to prevent chronic pain in at-risk adults with orthopedic injuries. Pilot Feasibility Stud. 2019 Feb 20;5:30. doi: 10.1186/s40814-019-0416-7. eCollection 2019.