Thrive Care: Internet CBT for Depression

NCT03079895 | Completed

• 1 other identifier: KP-RRC-20150408
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; internet; Cognitive Behavioral Therapy; CBT; computer; Primary Care; Psychiatry; treatment; self-help; managed care

Outcome Measures

Primary Outcomes (1)

• PHQ-9 score change

  Change in score on the 9-item Patient Health Questionnaire

  0-6 months after enrollment

Secondary Outcomes (9)

• GAD-7 score change

  0-6 months after enrollment

• Quality of Life change

  0-6 months after enrollment

• Workplace productivity change

  0-6 months after enrollment

• Medication adherence

  0-6 months after enrollment

• Psychotherapy utilization

  12 months prior to enrollment, through 6 months after enrollment

Study Arms (2)

Control Arm

NO INTERVENTION

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.

Intervention Arm

EXPERIMENTAL

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

Interventions

Thrive BEHAVIORAL

Thrive is an online self-help tool designed to assess for depressive symptoms and give therapeutic suggestions based on Cognitive Behavioral Therapy principals.

Also known as: Thrive for Depression

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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?"

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Fontana Medical Center

Fontana, California, 92335, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Roderick R Stuart, MD

  Southern California Permanente Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The primary care physician will not receive feedback about which arm the patient was assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: March 15, 2017
• Study Start: April 13, 2017
• Primary Completion: December 13, 2017
• Study Completion: December 13, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)