Status:
COMPLETED
Outcomes of a Self-guided Versus Therapist-guided Online Mental Health Treatment
Lead Sponsor:
Duke University
Collaborating Sponsors:
Charles Lafitte Foundation
Conditions:
Depression
Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pilot study of an online mental health treatment. The goals of the study are to determine the feasibility of an online treatment for depression and anxiety symptoms with little-to-no human s...
Detailed Description
The study is a 12-week, randomized controlled trial ("Hazel") comparing an intervention for depression and anxiety symptoms with two different levels of support. Eligible participants will be randomiz...
Eligibility Criteria
Inclusion
- 18+ years old
- Fluent in reading and writing English
- Internet/data plan and computer/tablet/phone access for length of study
- Overall Depression Severity and Impairment Scale (ODSIS) and/or Overall Anxiety Severity and Impairment Scale (OASIS) summary score \>= 8
- Live in North Carolina for the duration of the study
Exclusion
- Educational attainment greater than high school diploma/equivalent
- Currently receiving other psychotherapy or planning to receive other psychotherapy during course of intervention
- \>=8 sessions of cognitive-behavioral therapy in past 12 months
- Currently taking psychiatric medications or planning to take psychiatric medications during course of intervention
- Current suicidality, operationalized as a positive result on the Ask Suicide-Screening Questions (ASQ) Tool
- Self-harm in past 12 months
- Current psychosis, as measured by Mini International Neuropsychiatric Interview Subsection K. Psychotic Disorders
- Substance abuse (other than nicotine, cannabis or caffeine) in the past 12 months, as measured by Structured Clinical Interview for The Diagnostic and Statistical Manual of Mental Disorders-5 substance use disorders subsection (past 12 months only)
- BMI \<= 18.5
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04810988
Start Date
April 7 2021
End Date
June 30 2022
Last Update
July 22 2024
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27708