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Thrive Care: Internet CBT for Depression

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ClinicalTrials.gov Identifier: NCT03079895
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
This project will study the effectiveness of computerized cognitive behavioral therapy (CBT) in reducing depression symptoms. The design is a two-arm randomized controlled trial comparing (i) control arm, which is treatment as usual with (ii) treatment arm, which is treatment as usual plus computerized CBT. The primary outcome measure is change in depression symptom severity. The name of the computerized CBT program to be used in the study is Thrive.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Thrive Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial. Control arm will receive treatment as usual for depression from primary care physician. Intervention arm will also receive treatment as usual, and access to an internet-based self-help tool for treatment of depression, along with coaching emails and/or phone calls, encouraging their participation and answering questions about how to use the program.
Masking: Single (Care Provider)
Masking Description: The primary care physician will not receive feedback about which arm the patient was assigned to.
Primary Purpose: Treatment
Official Title: The Thrive Care Study: Computer-Delivered Cognitive Behavioral Therapy as Care Augmentation for Depressed Primary Care Patients
Actual Study Start Date : April 13, 2017
Actual Primary Completion Date : December 13, 2017
Actual Study Completion Date : December 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Arm
After enrollment in the study, the subject will continue to receive treatment as usual for their depression from their primary care physician. They then will be asked to complete 2-month and 6-month assessments about their emotional well-being.
Experimental: Intervention Arm
After enrollment in the study, the subject will be granted 8 weeks of access to "Thrive", an online self-help tool designed to assess for depressive symptoms and give therapeutic suggestions based on Cognitive Behavioral Therapy. During the first 4 weeks, they will receive 4 coaching emails and/or phone calls encouraging their participation in the study, and answering any program-related questions. The subject will also continue to receive treatment as usual for their depression from their primary care physician. They then will be asked to complete 2-month and 6-month assessments about their emotional well-being.
Behavioral: Thrive
Thrive is an online self-help tool designed to assess for depressive symptoms and give therapeutic suggestions based on Cognitive Behavioral Therapy principals.
Other Name: Thrive for Depression




Primary Outcome Measures :
  1. PHQ-9 score change [ Time Frame: 0-6 months after enrollment ]
    Change in score on the 9-item Patient Health Questionnaire


Secondary Outcome Measures :
  1. GAD-7 score change [ Time Frame: 0-6 months after enrollment ]
    Change in score on 7-item Generalized Anxiety Disorder scale

  2. Quality of Life change [ Time Frame: 0-6 months after enrollment ]
    Change in subjective measure of subject's quality of life (based on Behavioral Risk Factor Surveillance System)

  3. Workplace productivity change [ Time Frame: 0-6 months after enrollment ]
    Change in subjective measure of subject's workplace productivity (based on Behavioral Risk Factor Surveillance System)

  4. Medication adherence [ Time Frame: 0-6 months after enrollment ]
    Measure of compliance with prescribed medications, based on a single item question

  5. Psychotherapy utilization [ Time Frame: 12 months prior to enrollment, through 6 months after enrollment ]
    Subjective measurement of whether or not the subject has received psychotherapy from a licensed provider

  6. Psychiatric specialty utilization [ Time Frame: 0-6 months after enrollment ]
    Subjective measurement of whether or not the subject has received treatment from a provider in the Department of Psychiatry

  7. Satisfaction with Thrive [ Time Frame: 2 months after enrollment ]
    Subjective measurement of how satisfied patient was with the treatment intervention

  8. Satisfaction with Kaiser Permanente Southern California [ Time Frame: 0-6 months after enrollment ]
    Subjective measurement of how satisfied patient was with their experience of care at Kaiser Permanente Southern California

  9. Thrive Adherence [ Time Frame: 0-2 months after enrollment ]
    Percent enrolled in Thrive over total number invited, number of logins and lessons started



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Per EPIC (or other system) records, clinical depression was addressed during the prior week by a KPSC Fontana Family Medicine physician , reflected by an ICD-9 or ICD-10 diagnosis of Depression, Major Depressive Disorder, Dysthymia, Adjustment Disorder with Depressed Mood, and Depression Not Otherwise Specified. This does not have to be the patient's first depression diagnosis.
  • Screening Patient Health Questionnaire (PHQ-9) score of ≥5 as measured in Assessment Website (see Section 4 for information on Assessment Website)

Exclusion Criteria:

  • History or current diagnosis indicating any Schizophrenia spectrum or other psychotic disorder, any Neurocognitive disorder, Delirium, Bipolar disorder, Intellectual disability, or Personality disorder, or any active substance abuse, as defined by DSM-5
  • Member is not proficient in English
  • Member answered "more than half the days" or "nearly every day" on the Patient Health Questionnaire ninth item and did not subsequently answer (regarding suicidal ideations) "Yes" to the question "are you sure you can stay safe?"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079895


Locations
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United States, California
Kaiser Fontana Medical Center
Fontana, California, United States, 92335
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: Roderick R Stuart, MD Southern California Permanente Medical Group

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03079895     History of Changes
Other Study ID Numbers: KP-RRC-20150408
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:
Depression
internet
Cognitive Behavioral Therapy
CBT
computer
Primary Care
Psychiatry
treatment
self-help
managed care

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action