Status:
COMPLETED
Psychotherapy Feasibility Pilot of the Carolina Recovery From Depression Protocol
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
The Foundation of Hope for Research and Treatment of Mental Illness
Conditions:
Depression, Unipolar
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn whether an single session intervention can reduce psychological impairment in adult individuals with moderate depression. The main questions it aims to answ...
Eligibility Criteria
Inclusion
- Age of 18 years or older
- Able to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Speak and understand English
- Diagnostic and Statistical Manual (DSM)-5 diagnosis of major depressive disorder (MDD) as confirmed by semi-structured clinical assessment
- Meet a cutoff of at least a moderate depression score on the Beck Depression Inventory (BDI-II) (≥ 20)
Exclusion
- Participants must not have current active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as assessed by psychodiagnostic assessment
- Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
- Participants able to birth must not be pregnant or breastfeeding.
- Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
- Participants may not have undergone prior brain surgery
- Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
- Participants may not have had brain injury or concussion within the last three months
- Participants may not have a history of brain injury requiring current treatment
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06590038
Start Date
March 3 2025
End Date
April 24 2025
Last Update
June 4 2025
Active Locations (1)
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1
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States, 27516