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NCT02437188 · ClinicalTrials.gov registry record · NA
Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT
A NA study, sponsored by Barbara A Rakel.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
NCT02437188 is a NA study that has completed, run by Barbara A Rakel. The registered enrollment target is 88 participants.
The verdict
NCT02437188, a NA study, has completed, sponsored by Barbara A Rakel.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
Study Summary
A large number of veterans suffer from distress-based conditions, such as anxiety and depression, putting them at high risk of experiencing persistent pain and prolonged opioid use following surgery. These connections are based on strong and consistent evidence from the literature and our preliminary data. The proposed study adds a 1-day workshop of Acceptance and Commitment Therapy (ACT), followed by an individual "booster" session, to treatment as usual (TAU) to reduce veterans' risk of persistent pain and prolonged opioid use following surgery. ACT has been shown to be effective in reducing chronic pain, anxiety and depression. This pilot study will establish the feasibility and preliminary efficacy of incorporating ACT into treatment as usual (TAU) to preoperatively target distress-based risk factors. Aim 1 is to establish the feasibility of successfully delivering ACT to at-risk veterans before and after surgery. Aim 2 is to test the preliminary efficacy of ACT on the length and/or amount of pain and opioid use after surgery. Veterans who are anxious or depressed before surgery will be randomly assigned to receive ACT plus TAU or TAU. Outcomes between the two groups will be compared. Aim 3 is to see if PROMIS modules, developed by the National Institute of Health, are useful for assessing pain and other symptoms in veterans. Findings from this study will be used to inform the design and implementation of a larger, well controlled, randomized clinical trial that will evaluate the efficacy of ACT plus TAU for at-risk veterans. This study will take place at the Iowa City VA Health Care System (VAMC). Veterans scheduled for orthopedic or open abdominal surgery in 1 to 3 months who score high for anxiety or depression will be randomly assigned to attend a 1-day ACT workshop preoperatively, with an individualize "booster" session postoperatively, or to have TAU. Veterans who receive ACT and trainers who provide the treatment will be interviewed to identify barriers
Interventions
- BEHAVIORAL ACT (Acceptance and Commitment Therapy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2015-02 |
| Est. Completion | 2016-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02437188
The ClinicalTrials.gov registry entry for NCT02437188 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barbara A Rakel, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ACT (Acceptance and Commitment Therapy) is the first listed.
NCT02437188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02437188 about?
NCT02437188 is a clinical study titled "Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT". A large number of veterans suffer from distress-based conditions, such as anxiety and depression, putting them at high risk of experiencing persistent pain and prolonged opioid use following surgery. These connections are based on strong and consistent evidence from the literature and our preliminar...
What is the current status of trial NCT02437188?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2015-02. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02437188?
The interventions under investigation include: ACT (Acceptance and Commitment Therapy) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02437188?
This trial is sponsored by Barbara A Rakel, which has 3 total clinical trials registered on ClinicalTrials.gov.
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