Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

Not Applicable

Completed

• Conditions: Fractures, Bone
• Interventions: Behavioral: Behavioral Activation

• Registration Number: NCT04426981
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-10-09
• Primary Completion: 2021-09-03
• Study Completion: 2021-09-03
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Behavioral Activation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States