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FractureOI-DBTNCT03776929

Dialectical Behavioral Therapy in High Risk OrthopaedicTrauma Patients

A study testing Dialectical Behavioral Therapy in people with Fracture and Surgery, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fracture, Surgery
What is being tested?
Dialectical Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2020to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

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.

Read the detailed description

Musculoskeletal injuries represent one of the leading causes of hospital admissions for adults, and often results in long term pain, poor function, and permanent disability. Patients afflicted with musculoskeletal injuries contribute to an enormous cost to society in terms of direct health care spending, as well as indirect costs related to permanent disability, loss of work, and chronic pain contributing to the rising opioid epidemic. This is clearly a substantial and costly issue at Dartmouth-Hitchcock Medical Center (DHMC) as well as the country at large. From 2011 to 2017, 54% of patients who were admitted for fracture at DHMC had either a psychiatric diagnosis and/or a substance abuse diagnosis. It is likely that this number vastly underestimates the true amount of emotional distress present in this patient population because many patients with these issues do not carry formal psychiatric diagnoses. Diagnosis of psychiatric illness or substance abuse was associated with significantly higher resource utilization during hospital admission in terms of hospital length of stay (LOS, mean difference 3 days), need for ICU stay, number of consulting services, disposition to rehab, and rate of unplanned readmissions (21% versus 39%, respectively). Furthermore, this patient population had significantly higher mean pain score during admission and required 10-fold more opioids prescribed [measured in total morphine equivalents (MME)] and number of separate prescriptions needed.

These data within the investigator's own patient population reinforce the well documented reciprocal association between chronic pain and adverse mental health outcomes, such that pain triggers depression for example, but depression may as well exacerbate experiences of pain. In fact, catastrophic thinking about pain (tendency to assume the worst and believe that one will be unable to cope with the outcome), pain anxiety, and symptoms of depression are key factors that explain the magnitude of disability and pain intensity after musculoskeletal trauma. Resilience, the capacity to adapt to or recover from adversity, has been shown to attenuate the association between depression and pain. For this reason, the investigators believe it is important for patients to learn effective coping skills in order to effectively manage their pain and fear associated with recovering from a traumatic injury.

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. This psychosocial treatment aims to reduce ineffective action tendencies associated with dysregulated emotions. DBT has been studied extensively in adult samples, across a wide range of settings. It has been shown to be effective in management of intense emotional states and development of coping skills in the most challenging patient populations including patients with Borderline Personality Disorder (BPD), eating disorders, and substance abuse. Furthermore, DBT-based interventions have demonstrated preliminary effectiveness in managing chronic pain and pain catastrophizing and anxiety. As such, patients with orthopedic trauma at high risk for chronic pain and disability would benefit from an evidence-based treatment approach that would teach them how to change thoughts, feelings, and behaviors that could cause problems in daily living and interfere with recovery from injury.

Conditions
Fracture, Surgery
Being tested
Dialectical Behavioral Therapy
Keywords
Dialectical Behavioral Therapy, Orthopaedic, Trauma, Pain Catastrophizing Scale
Medical subject headings
Fractures, Bone, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavioral TherapyBehavioural

    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.

Study groups in NCT03776929
Study groupRoleWhat they receive
Standard CareNo interventionNo intervention - Standard care only. Group of 32 subjects
Dialectical Behavioral TherapyExperimentalDialectical 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.
Receives: Behavioral: Dialectical Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Number of Opioids Administered

    The opioids administered during hospitalization measured in total morphine equivalents

    Measured: Hospital admission to hospital discharge, approximately 4-7 days

Secondary outcomes (5)
  1. Change over time in General Health Status

    Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health: 10-item measure of physical and mental health. Scale range 0 to 100, mean 50, standard deviation 10. A higher score represents a better outcome.

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

  2. Change over time in Psychological Functioning - Depression

    Patient Health Questionnaire-9 (PHQ-9): 9-item measure of major depression symptom severity on a 4-point Likert-type scale. Score range 0-27; Higher score indicates more severe depressive symptoms.

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

  3. Change over time in Psychological Functioning - PTSD

    PTSD Checklist for DSM-5 (PCL-5): 20-item measure of DSM-5 PTSD symptom severity on a 5-point Likert-type scale. Scale range 0-80. Higher score indicates more severe PTSD symptoms

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

  4. Change over time in Pain Anxiety: PASS-20

    Pain Anxiety Symptoms Scale (PASS-20): 20-item measure of pain anxiety on a 6-point Likert-type scale. Scale range 0-100. Higher score indicates more pain-related anxiety

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

  5. Change over time in Pain Interference: BPI-SF

    Brief Pain Inventory-Short Form (BPI-SF): 9-item measure of pain severity and impact of pain on daily functions. This is a 10-point scale with 0 being the best possible score, meaning "no pain", and 10 being the worst possible score, meaning "pain as bad as you can imagine".

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2018
  2. Study startApr 2020 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Why it stopped: Study is temporarily suspended until resources are put in place for enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03776929
Sponsor's protocol ID
D18154
Acronym
OI-DBT
Status last verified
Mar 2020
First submitted
15 Nov 2018
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavioral Therapy in people with Fracture and Surgery, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change over time in Pain Severity: VAS (time frame: Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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