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Completed

NCT Number: NCT02384590

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15237, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 years of age at baseline visit.
  • Documentation of a SCD diagnosis (HgbSS, HgbSC, SBeta +Thal; or SBeta oThal)
  • Receive routine care at the UPMC sickle cell clinic.
  • 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

  • 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.

Treatment and study plan

Computerized Cognitive Behavioral Therapy

Behavioral

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: online cognitive behavioral therapy, Internet-delivered cognitive behavioral therapy, Beating the Blues

Primary outcomes

  1. Patient acceptability as measured by CCBT sessions completed

    Time frame: 6-months

    Number of CCBT sessions completed while enrolled in study

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study 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

Acronym: CaRISMA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2015
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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