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Completed

NCT Number: NCT04426981

Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

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.

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Key information

Conditions

Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Percentage of patients who agree to enroll

    Time frame: 6 months

    Feasibility will be assessed based on percentage of patients who agree to enroll sessions

  2. Score on Modified Treatment Evaluation Inventory Short Form

    Time frame: 6 months

    Acceptability will be measured qualitatively and using the Modified Treatment Evaluation Inventory Short Form

  3. Percentage of patients who complete 5 out of 8 possible Behavioral Activation sessions

    Time frame: 6 months

    Feasibility will be assessed based on patients who complete 5 out of 8 possible Behavioral Activation Sessions

Secondary outcomes

  1. Score on PROMIS general health survey (Response range is 0 to 100 where 100 indicates better function)

    Time frame: 6 months

    Preliminary efficacy on functional outcome will be assessed using patient reported functional outcome using PROMIS general health survey

  2. Score on VAS pain score (Response range is from 0 to 10 where 10 indicates greater pain)

    Time frame: 6 months

    Pain-related preliminary efficacy will be assessed using patient reported VAS pain score will be assessed

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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