Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Fractures, Bone
• Intervention / Treatment: Behavioral: Behavioral Activation

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Intervention arm; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2020
• Primary Completion (ACTUAL): September 3, 2021
• Study Completion (ACTUAL): September 3, 2021

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: D20133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No