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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04426981
Other study ID # D20133
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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