Clinical trial NCT02384590: Cognitive Behavioral Therapy and Real-time Self-management Intervention for SCD Via Mobile Applications
Official title: Feasibility of Implementing Mental Health Treatment in Routine Adult Sickle Cell Disease Care Using Online Cognitive Behavioral Therapy and a Mobile Technology-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Depression
Anxiety
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Patient acceptability as measured by CCBT sessions completed
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References: