Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study
Primary Purpose
Fractures, Bone
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Sponsored by
About this trial
This is an interventional treatment trial for Fractures, Bone
Eligibility Criteria
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)
Sites / Locations
- Dartmouth Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of patients who agree to enroll
Feasibility will be assessed based on percentage of patients who agree to enroll sessions
Score on Modified Treatment Evaluation Inventory Short Form
Acceptability will be measured qualitatively and using the Modified Treatment Evaluation Inventory Short Form
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04426981
First Posted
June 9, 2020
Last Updated
January 26, 2022
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04426981
Brief Title
Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study
Official Title
Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
September 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients who agree to enroll
Description
Feasibility will be assessed based on percentage of patients who agree to enroll sessions
Time Frame
6 months
Title
Score on Modified Treatment Evaluation Inventory Short Form
Description
Acceptability will be measured qualitatively and using the Modified Treatment Evaluation Inventory Short Form
Time Frame
6 months
Title
Percentage of patients who complete 5 out of 8 possible Behavioral Activation sessions
Description
Feasibility will be assessed based on patients who complete 5 out of 8 possible Behavioral Activation Sessions
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Score on PROMIS general health survey (Response range is 0 to 100 where 100 indicates better function)
Description
Preliminary efficacy on functional outcome will be assessed using patient reported functional outcome using PROMIS general health survey
Time Frame
6 months
Title
Score on VAS pain score (Response range is from 0 to 10 where 10 indicates greater pain)
Description
Pain-related preliminary efficacy will be assessed using patient reported VAS pain score will be assessed
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study
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