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NCT05774002 · ClinicalTrials.gov registry record · NA
Psychological Assessment of Scoliosis Patients Undergoing Surgical Management
A NA study of Mental Health and Adolescent Idiopathic Scoliosis (AIS), sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05774002: Recruiting NA study of Mental Health and Adolescent Idiopathic Scoliosis (AIS), sponsored by Montefiore Medical Center.
NCT05774002 is a NA study of Mental Health and Adolescent Idiopathic Scoliosis (AIS) that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 120 participants, below the 10,181-participant average among 62 other Mental Health trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05774002, a NA study of Mental Health and Adolescent Idiopathic Scoliosis (AIS), is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the investigators have designed a prospective randomized clinical trial (2:1) study for 45 Adolescent Idiopathic Scoliosis (AIS) patients, 10-19 years of age. This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome (PRO) measures. The investigators will implement and test a structured perioperative psychological intervention program, based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which was developed based on evidence-based cognitive behavioral therapy (CBT) protocols for the management of pediatric pain and childhood anxiety disorders
Primary Outcome
Assessment of changes in anxiety, preoperatively to postoperatively, will be assessed using the Beck Anxiety Inventory (BAI). The BAI is a 21-item, self-report tool used to assess anxiety severity over the prior week. Participants are asked to rate their anxiety symptoms using a scale of 0-3 which correlate to "Not at all," "Mildly," "Moderately," or "Severely," respectively. Scores are then totaled yielding an overall range of 0-63. Scores of 0-7 are indicative of low anxiety; 8-15 mild anxiety
Conditions Studied
Interventions
- BEHAVIORAL Aims to Decrease Anxiety and Pain Treatment (ADAPT)
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-10-06 |
| Est. Completion | 2028-10 |
| Phase | NA |
What NCT05774002 shows while recruiting
NCT05774002 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 10,181-participant average among 62 other Mental Health trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Mental Health appearing as the primary indexed condition, and to 1 intervention - of which Aims to Decrease Anxiety and Pain Treatment (ADAPT) is the first listed.
NCT05774002 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05774002 about?
NCT05774002 is a clinical study titled "Psychological Assessment of Scoliosis Patients Undergoing Surgical Management". Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the investigators have designed a prospective randomized clinical trial (2:1) study for 45 Adolescent Idiopathic Scoliosis (AIS) patients, 10-19 years of age. This protocol includes a baseline assessment of men...
What is the current status of trial NCT05774002?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2023-10-06. Estimated completion is 2028-10.
What conditions does trial NCT05774002 study?
This clinical trial studies the following conditions: Mental Health, Adolescent Idiopathic Scoliosis (AIS).
What interventions are being tested in trial NCT05774002?
The interventions under investigation include: Aims to Decrease Anxiety and Pain Treatment (ADAPT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05774002?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05774002 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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