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Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04426981
Enrollment
10
Registered
2020-06-11
Start date
2020-10-09
Completion date
2021-09-03
Last updated
2022-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures, Bone

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.

Interventions

BEHAVIORALBehavioral 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.

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients who agree to enroll6 monthsFeasibility will be assessed based on percentage of patients who agree to enroll sessions
Score on Modified Treatment Evaluation Inventory Short Form6 monthsAcceptability 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 sessions6 monthsFeasibility will be assessed based on patients who complete 5 out of 8 possible Behavioral Activation Sessions

Secondary

MeasureTime frameDescription
Score on PROMIS general health survey (Response range is 0 to 100 where 100 indicates better function)6 monthsPreliminary 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)6 monthsPain-related preliminary efficacy will be assessed using patient reported VAS pain score will be assessed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026