Dialectical Behavioral Therapy in High Risk OrthopaedicTrauma Patients

NCT03776929 | Withdrawn

• 1 other identifier: D18154
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Psychological factors can affect the experience of pain and functional recovery from orthopedic injury. The purpose of this study is to examine the effect of brief Dialectical Behavior Therapy (DBT), a form of psychotherapy, on changing thoughts, feelings, and behaviors that can cause problems in daily living and interfere with recovery from orthopedic injury in patients who are at high risk for chronic pain and disability.

Conditions

Fracture; Surgery

Keywords

Dialectical Behavioral Therapy; Orthopaedic; Trauma; Pain Catastrophizing Scale

Outcome Measures

Primary Outcomes (2)

• Change over time in Pain Severity: VAS

  Visual Analogue Scale (VAS) Pain scores documented in the patient's medical record. Score Range 0-10. Higher score indicates greater pain.

  Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up

• Number of Opioids Administered

  The opioids administered during hospitalization measured in total morphine equivalents

  Hospital admission to hospital discharge, approximately 4-7 days

Secondary Outcomes (5)

• Change over time in General Health Status

  Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up

• Change over time in Psychological Functioning - Depression

  Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up

• Change over time in Psychological Functioning - PTSD

  Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up

• Change over time in Pain Anxiety: PASS-20

  Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up

• Change over time in Pain Interference: BPI-SF

  Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up

Study Arms (2)

Standard Care

NO INTERVENTION

No intervention - Standard care only. Group of 32 subjects

Dialectical Behavioral Therapy

EXPERIMENTAL

Dialectical Behavioral Therapy in addition to standard care. Four hour and a half group sessions (or one-on-one sessions, if not enough for a group session) commencing after surgery while still inpatient. Each session is designed to stand-alone, allowing for enrolling patients on a rolling basis.

Behavioral: Dialectical Behavioral Therapy

Interventions

Dialectical Behavioral Therapy BEHAVIORAL

Dialectical Behavior Therapy (DBT) is a cognitive behavioral therapy that focuses on the balance between change and acceptance. DBT skills include four modules: two that enforce acceptance-oriented skills, mindfulness and distress tolerance, and two that promote change-oriented skills, interpersonal effectiveness and emotional regulation.

Dialectical Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Admitted to Dartmouth-Hitchcock Medical Center with an operatively treated fracture.

You may not qualify if:

• Non-English speaking
• Pain Catastrophizing Scale (PCS) score of \< 13
• Anticipating hospital length of stay of less than 2 days
• Are expected to have severe problems maintaining follow-up and treatment recommendations
• Have current or impending incarceration
• Are actively psychotic or manic

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Wounds and Injuries

Study Officials

• Ida L Gitajn, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: December 17, 2018
• Study Start: April 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

US (1)