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

January 23, 2017 updated by: Charles Jonassaint, University of Pittsburgh

Feasibility of Implementing Mental Health Treatment in Routine Adult Sickle Cell Disease Care Using Online Cognitive Behavioral Therapy and a Mobile Technology-Based Intervention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15237
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CCBT + Care Manager Arm
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.
Behavioral: Computerized cognitive behavioral therapy
The "Beating the Blues" computerized cognitive behavioral therapy (CCBT) program is eight 50-minute online sessions that teach the participant how to better manage stress using cognitive behavioral therapy techniques. Cognitive behavioral therapy involves helping people change their thoughts and behaviors so they can limit the negative impact stress will have on their mood and pain experience.
Other Names:
  • Beating the Blues
  • online cognitive behavioral therapy
  • Internet-delivered cognitive behavioral therapy
No Intervention: Treatment As Usual
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient acceptability as measured by CCBT sessions completed
Time Frame: 6-months
Number of CCBT sessions completed while enrolled in study
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 17, 2017

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO14120495

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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