Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

Fractures, Bone Clinical Trial

Official title:

Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426981
• Other study ID #: D20133
• Status: Completed
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: September 3, 2021

Study information

• Verified date: January 2022
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who agree to enroll	Feasibility will be assessed based on percentage of patients who agree to enroll sessions	6 months
Primary	Score on Modified Treatment Evaluation Inventory Short Form	Acceptability will be measured qualitatively and using the Modified Treatment Evaluation Inventory Short Form	6 months
Primary	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	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
Secondary	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