Psychotherapy Feasibility Pilot of the Carolina Recovery From Depression Protocol (CARED)

University of North Carolina (UNC)

Status: Completed

Conditions: Depression, Unipolar

Treatments: Behavioral: Single Session Psychotherapy Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06590038

23-1988

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Psychotherapy Arm

Experimental group

Treatment:

Behavioral: Single Session Psychotherapy Intervention