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NCT03965897 · ClinicalTrials.gov registry record · Phase 2
Preventing Persistent Post-Surgical Pain and Dysfunction
A Phase 2 study of Depression and Pain, sponsored by Barbara A Rakel.
- Completed
- Registry status
- Phase 2
- Development phase
- 487
- Enrollment target
- 1
- Study location
NCT03965897 is a Phase 2 study of Depression and Pain that has completed, run by Barbara A Rakel. The registered enrollment target is 487 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03965897, a Phase 2 study of Depression and Pain, has completed, sponsored by Barbara A Rakel.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 487 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Aim: To examine the superior efficacy of ACT versus Attention Control (AC) on postoperative pain intensity and functioning in at-risk Veterans undergoing TKA. Changes in pain intensity and functioning from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Level of pain intensity will be measured using the BPI Pain Severity Subscale and level of functioning will be measured using the KOOS Activities of Daily Living and Quality Of Life Subscales. Secondary Aims: A) To examine the superior efficacy of ACT versus AC on the severity of anxiety and depressive symptoms and improvements in coping skills. Changes from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Anxiety and depressive symptoms will be measured with the Hamilton Rating Scales (Ham-A and Ham-D, respectively). Coping skills (i.e. Pain Acceptance and Engagement in Values-Based Behavior) will be measured with the Chronic Pain Acceptance Questionnaire and the Chronic Pain Values Inventory. B) To evaluate whether decreases in distress-based symptoms and increases in coping skills mediate changes in pain and functioning at 6 months in Veterans receiving ACT. Changes in anxiety symptoms, depressive symptoms, pain acceptance and engagement in values-based behavior from baseline to 6 weeks and 3 months will be used as potential mediators for changes in pain and functioning at 6 months. Exploratory Aim: Describe the pharmacological and non-pharmacological strategies Veterans are using to manage pain and their perceived helpfulness. This will provide insights into the effects of the current opioid restrictions on pain management strategies. These strategies \& their perceived helpfulness will be assessed using the Pain Management Strategies Survey at baseline, 6 weeks, 3, and 6 months.
Conditions Studied
Interventions
- BEHAVIORAL Acceptance and Committment Therapy (ACT)
- OTHER Attention Control (AC)
Study Locations (1)
Iowa
- Iowa City VAMC - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 487 participants |
| Start Date | 2019-07-29 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03965897
The ClinicalTrials.gov registry entry for NCT03965897 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 487 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (38% lower). The listed sponsor is Barbara A Rakel, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Acceptance and Committment Therapy (ACT) is the first listed.
NCT03965897 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT03965897 about?
NCT03965897 is a clinical study titled "Preventing Persistent Post-Surgical Pain and Dysfunction". Primary Aim: To examine the superior efficacy of ACT versus Attention Control (AC) on postoperative pain intensity and functioning in at-risk Veterans undergoing TKA. Changes in pain intensity and functioning from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Level of pain in...
What is the current status of trial NCT03965897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 487 participants. The study started on 2019-07-29. Estimated completion is 2024-01-30.
What conditions does trial NCT03965897 study?
This clinical trial studies the following conditions: Depression, Pain, Anxiety, Arthroplasty, Replacement, Knee, Veterans.
What interventions are being tested in trial NCT03965897?
The interventions under investigation include: Acceptance and Committment Therapy (ACT) (BEHAVIORAL), Attention Control (AC) (OTHER).
Who is sponsoring clinical trial NCT03965897?
This trial is sponsored by Barbara A Rakel, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03965897 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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