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Cognitive Behavioral Therapy
eCBT for Depression (AMHI Trial)
N/A
Recruiting
Led By Robert Bossarte, PhD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 week follow-up
Awards & highlights
AMHI Trial Summary
This trial will test whether or not providing rural primary care clinicians with access to eCBT will help improve treatment of patients with MDD.
Who is the study for?
This trial is for individuals in rural West Virginia and Kentucky who are literate in English, seeking treatment for Major Depressive Disorder (MDD) for the first time in six months, have access to a smartphone or computer, and are suitable for outpatient treatment. It excludes those with hearing, vision or cognitive impairments that affect research participation.Check my eligibility
What is being tested?
The study tests if giving primary care doctors access to remote internet-based Cognitive Behavior Therapy (eCBT) can improve MDD treatment outcomes. Participants will receive eCBT through their smart devices or computers.See study design
What are the potential side effects?
Since this intervention involves therapy rather than medication, typical side effects associated with drugs may not apply. However, participants might experience emotional discomfort during therapy sessions as they address personal issues.
AMHI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 week follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
RDQ-7
Secondary outcome measures
Compliance with Antidepressant Medication Treatment
PROMIS Short Form v1.0 - Severity of Substance Use (past 30 days)
SDM-Q-9
AMHI Trial Design
3Treatment groups
Active Control
Group I: Primary Care TreatmentActive Control1 Intervention
The participant will receive treatment as usual as prescribed by the primary care physician for MDD.
Group II: Primary care treatment with guided eCBTActive Control1 Intervention
The participant will receive treatment as usual as prescribed by the primary care physician with the addition of guided eCBT for MDD.
Group III: Primary care treatment with eCBTActive Control1 Intervention
The participant will receive treatment as usual as prescribed by the primary care physician with the addition of eCBT for MDD.
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Who is running the clinical trial?
West Virginia UniversityLead Sponsor
176 Previous Clinical Trials
56,854 Total Patients Enrolled
3 Trials studying Depression
561 Patients Enrolled for Depression
University of South FloridaLead Sponsor
412 Previous Clinical Trials
183,699 Total Patients Enrolled
18 Trials studying Depression
5,284 Patients Enrolled for Depression
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,994,088 Total Patients Enrolled
30 Trials studying Depression
133,793 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can receive treatment without staying in the hospital.You have never had bipolar disorder or non-affective psychosis.I am seeking treatment for major depressive disorder for the first time in 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Care Treatment
- Group 2: Primary care treatment with guided eCBT
- Group 3: Primary care treatment with eCBT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the patient enrollment rate for this clinical trial?
"Right. The details on clinicaltrials.gov affirm that this medical trial is presently recruiting, having initially been posted on September 1st 2021 and most recently updated November 9th 2021. In total, 3360 participants are required from 12 distinct clinics for the research to be completed successfully."
Answered by AI
Could you please provide the quantity of healthcare centers participating in this trial?
"Currently, this medical experiment is recruiting from a total of 12 sites; 3 in Glenville, Huntington and Elizabeth respectively as well as 9 other cities. To reduce burden on participants, it is suggested to sign up at the closest site possible."
Answered by AI
Are additional participants being solicited for this experiment?
"Affirmative. The information posted on clinicaltrials.gov suggests that this research endeavor is actively seeking participants, having first been made public on January 9th 2021 and updated most recently on November 9th 2021. This trial requires 3360 volunteers across 12 different sites to be recruited in total."
Answered by AI
Who else is applying?
What state do they live in?
West Virginia
Tennessee
Kentucky
What site did they apply to?
Harpers Ferry Family Medicine
WVU Medicine
University of Lousiville Health
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I need to unbox my head.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 1 Day
Most responsive sites:
- Hurricane Clinic: < 24 hours
Typically responds via
Email
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