NCT06590038Completed
Psychotherapy Feasibility Pilot of the Carolina Recovery From Depression Protocol
Psychotherapy Feasibility and Acceptability Pilot of the Carolina Recovery From Depression Protocol (CARED): A Novel Rapid Treatment Paradigm for Depression
Source: ClinicalTrials.gov · Last updated 4 Jun 2025
Brief summary (registry, in English)
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 answer are: Is this evidence-based intervention acceptable to study participants? Is this evidence-based intervention feasible to implement in a single session? Is there evidence that the evidence-based intervention reduces psychological impairment in adults with moderate to severe depression? Participants will complete: * an in-depth diagnostic screening interview prior to enrollment * a set of mental health questionnaires at baseline and two weeks post-intervention * a 3-hour, evidence-based, single session psychotherapeutic intervention with a trained clinician
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 5 Sept 2024
- Start date
- 3 Mar 2025
- Primary completion date
- 24 Apr 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Depression
- NCT number
- NCT06590038
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 3 Mar 2025 to the primary completion date, 24 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 may not have undergone prior brain surgery
- Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
Other illness
- Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as assessed by psychodiagnostic assessment
- Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
- Participants may not have a history of brain injury requiring current treatment
Other
- Participants must not have current active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Participants able to birth must not be pregnant or breastfeeding.
- Participants may not have had brain injury or concussion within the last three months
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carolina Center for Neurostimulation Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.