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

NCT ID: NCT03405610

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2018-08-01

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.

Conditions

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Musculoskeletal Injury Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Toolkit for Optimal Recovery after Injury

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.

Group Type EXPERIMENTAL

The Toolkit for Optimal Recovery after Injury

Intervention Type BEHAVIORAL

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.

Usual Care

The Usual Care (UC) group will continue with their current medical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The Toolkit for Optimal Recovery after Injury

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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ToR

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ana-Maria Vranceanu, PhD

Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana-Maria Vranceanu, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30820341 (View on PubMed)

Other Identifiers

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2014P001194

Identifier Type: -

Identifier Source: org_study_id

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