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

Not Applicable

Completed

• Conditions: Sickle Cell Disease; Depression; Anxiety
• Interventions: Behavioral: Computerized cognitive behavioral therapy

• Registration Number: NCT02384590
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-26
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01-17
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male or female ≥18 years of age at baseline visit.
2. Documentation of a SCD diagnosis (HgbSS, HgbSC, SBeta +Thal; or SBeta oThal)
3. Receive routine care at the UPMC sickle cell clinic.
4. Scores indicative of clinically significant depression or anxiety on the stress/pain screener that is administered as part of routine SCD care to all patients. i.e. Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Generalized Anxiety Disorder scale (GAD-7) ≥ 8

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Exclusion Criteria

1. Presence of a condition or abnormality (e.g. significant neurocognitive dysfunction) that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCBT + Care Manager Arm	Computerized cognitive behavioral therapy	Patients will be given a tablet device with unlimited data. The device will be pre-installed with a pain and mood diary app that will prompt them to enter their pain severity (0-10), pain location, and mood (0-10), once a day. They will also be registered on to the Beating the Blues website and asked to use the tablet device to complete eight 1-hour Beating the Blues CBT sessions, over the next 3-months. They will also be introduced to a care manager who will contact them on a weekly basis by telephone and throughout the week by email or text, for one-month and then as needed for two additional months. At the conclusion of 3 months participants will only have care manager support upon request but are free to continue using the Beating the Blues program for as long as they like.

Primary Outcome Measures

Name	Time	Method
Patient acceptability as measured by CCBT sessions completed	6-months	Number of CCBT sessions completed while enrolled in study

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States