Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

NCT04426981 | Completed

• 1 other identifier: D20133
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Interventions

Behavioral Activation BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older
• Presenting at initial (approximately 2-week) postoperative follow-up
• Prior management of isolated fracture or multi-trauma

You may not qualify if:

• Incarceration
• Problems, in the judgement of study personnel, with maintaining follow-up
• Cognitive disability (either acute or chronic)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: October 9, 2020
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)