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

University of Pittsburgh

Status: Completed

Conditions: Depression; Sickle Cell Disease; Anxiety

Treatments: Behavioral: Computerized cognitive behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02384590

PRO14120495

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

CCBT + Care Manager Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Computerized cognitive behavioral therapy

Treatment As Usual

No Intervention group

Description:

Similar to the treatment arm, patients will be given a tablet device with unlimited data that comes pre-loaded with a pain and mood diary app. The app will prompt the usual care patients to complete diary data daily. No other activities are required as part of the study but the patients are free to use the tablet as much as they like for their own leisure. At the end of 3-months, patients who continue to report depressive or anxiety symptoms are invited to cross-over to the treatment arm where they will be registered for the Beating the Blues program and given care manger support.