Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

Study Overview
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Brief Summary
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This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury.

Detailed Description
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This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury. Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.

Official Title
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Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

Conditions
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Fractures, Bone

Intervention / Treatment
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* Behavioral: Behavioral Activation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years or older Presenting at initial (approximately 2-week) postoperative follow-up Prior management of isolated fracture or multi-trauma Exclusion Criteria: Incarceration Problems, in the judgement of study personnel, with maintaining follow-up Cognitive disability (either acute or chronic)

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Consenting patients will be enrolled into a Behavioral Activation treatment arm. Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. | Behavioral: Behavioral Activation<br>* Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who agree to enroll | Feasibility will be assessed based on percentage of patients who agree to enroll sessions | 6 months | 
| Score on Modified Treatment Evaluation Inventory Short Form | Acceptability will be measured qualitatively and using the Modified Treatment Evaluation Inventory Short Form | 6 months | 
| Percentage of patients who complete 5 out of 8 possible Behavioral Activation sessions | Feasibility will be assessed based on patients who complete 5 out of 8 possible Behavioral Activation Sessions | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on PROMIS general health survey (Response range is 0 to 100 where 100 indicates better function) | Preliminary efficacy on functional outcome will be assessed using patient reported functional outcome using PROMIS general health survey | 6 months | 
| Score on VAS pain score (Response range is from 0 to 10 where 10 indicates greater pain) | Pain-related preliminary efficacy will be assessed using patient reported VAS pain score will be assessed | 6 months |