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Clinical Trials/NCT04426981
NCT04426981CompletedNot Applicable

Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

Dartmouth-Hitchcock Medical Center2 sites in 1 country10 target enrollmentStarted: October 9, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
Percentage of patients who complete 5 out of 8 possible Behavioral Activation sessions

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

Percentage of patients who complete 5 out of 8 possible Behavioral Activation sessions

Time Frame: 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

Time Frame: 6 months

Feasibility will be assessed based on percentage of patients who agree to enroll sessions

Score on Modified Treatment Evaluation Inventory Short Form

Time Frame: 6 months

Acceptability will be measured qualitatively and using the Modified Treatment Evaluation Inventory Short Form

Secondary Outcomes

  • Score on PROMIS general health survey (Response range is 0 to 100 where 100 indicates better function)(6 months)
  • Score on VAS pain score (Response range is from 0 to 10 where 10 indicates greater pain)(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ida Leah Gitajn

Assistant Professor

Dartmouth-Hitchcock Medical Center

Study Sites (2)

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