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NCT02384590 · ClinicalTrials.gov registry record · NA

Cognitive Behavioral Therapy and Real-time Self-management Intervention for SCD Via Mobile Applications

A NA study of Depression and Anxiety, sponsored by University of Pittsburgh.

Completed
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT02384590 is a NA study of Depression and Anxiety that has completed, run by University of Pittsburgh. The registered enrollment target is 30 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02384590, a NA study of Depression and Anxiety, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

Patients with sickle cell disease (SCD) experience significant depressive symptoms that currently go unrecognized and under-treated. Further, depression in this patient population has the potential to contribute to high health care utilization and poor disease outcomes; however, there are currently no comparative effectiveness studies of evidenced-based mental health treatments for depression in SCD. The primary objective of this study is to test the effectiveness of an online computerized cognitive behavioral therapy intervention to address psychological and behavioral needs of patients with sickle cell disease, namely depression and pain symptoms. The investigators will implement an existing computerized cognitive behavioral therapy (CCBT) program called "Beating the Blues" into routine clinical care at the University of Pittsburgh Medical Center (UPMC) Adult Sickle Cell Clinic to determine the effectiveness of this intervention in decreasing depression and pain versus treatment as usual. Patients with significant distress-depression and/or anxiety symptoms-will be randomized to either eight sessions of a CCBT program and weekly follow-up with a care manager or treatment as usual where the treating physician is notified of the patient's symptoms. The investigators will evaluate patient acceptability, implementation and practicality of the online mental health intervention through patient use of the site (frequency and duration of visits), qualitative interviews, and surveys. The investigators hypothesize: 1) the CCBT will be an acceptable mental health treatment for patients and easily integrated into routine clinical care; 2) patients in the treatment arm will show a greater decrease in depression/anxiety symptoms and average daily pain than patients in usual care.

Interventions

  • BEHAVIORAL Computerized cognitive behavioral therapy

Study Locations (1)

Pennsylvania

  • University of Pittsburgh - Pittsburgh

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2015-03
Est. Completion 2017-01-17
Phase NA

Sponsor

University of Pittsburgh

1,238 total trials

What the Registry Record Tells You About NCT02384590

The ClinicalTrials.gov registry entry for NCT02384590 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 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 (96% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Computerized cognitive behavioral therapy is the first listed.

NCT02384590 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT02384590 about?

NCT02384590 is a clinical study titled "Cognitive Behavioral Therapy and Real-time Self-management Intervention for SCD Via Mobile Applications". Patients with sickle cell disease (SCD) experience significant depressive symptoms that currently go unrecognized and under-treated. Further, depression in this patient population has the potential to contribute to high health care utilization and poor disease outcomes; however, there are currently ...

What is the current status of trial NCT02384590?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2015-03. Estimated completion is 2017-01-17.

What conditions does trial NCT02384590 study?

This clinical trial studies the following conditions: Depression, Anxiety, Sickle Cell Disease.

What interventions are being tested in trial NCT02384590?

The interventions under investigation include: Computerized cognitive behavioral therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT02384590?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02384590 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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