Psychotherapy Feasibility and Acceptability Pilot of the Carolina Recovery From Depression Protocol (CARED): A Novel Rapid Treatment Paradigm for Depression

University of North Carolina, Chapel Hill1 site in 1 country10 target enrollmentMarch 3, 2025

ConditionsDepression, Unipolar

Overview

Phase: N/A
Intervention: Not specified
Conditions: Depression, Unipolar
Sponsor: University of North Carolina, Chapel Hill
Enrollment: 10
Locations: 1
Primary Endpoint: CARED Treatment Experience Survey
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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

Registry

clinicaltrials.gov

Start Date

March 3, 2025

End Date

April 24, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of North Carolina, Chapel Hill

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

CARED Treatment Experience Survey

Time Frame: Immediately post-intervention (same day)

A brief survey which probes the qualitative experience of participants during the intervention (i.e., tolerability, their level of engagement, satisfaction with treatment). Participants respond to eight items, rated on a 4-point Likert scale (1 - Not at all to 4 - Completely) to indicate their level of agreement with each item. Higher scores on the measure indicate greater tolerability, satisfaction, and endorsement of treatment. Total possible scores range from 8 to 32.

Secondary Outcomes

Change from baseline on Behavioral Activation Scale at two weeks post-intervention(Baseline and Two Weeks post-intervention)
Change in baseline Repetitive Thinking Questionnaire - 10 item form to two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Snaith-Hamilton Pleasure Scale at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Inhibition Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Drive Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Fun Seeking Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Reward Responsiveness Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Quality of Life Enjoyment and Satisfaction Questionnaire at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Dimensional Anhedonia Rating Scale at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Intolerance of Uncertainty Scale at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Flexibility Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Inflexibility Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Self-Compassion Scale Short Form at two weeks post-intervention(Baseline and Two weeks post-intervention)
Change from baseline on Becks Depression Inventory II at two weeks post-intervention(Baseline and Two weeks post-intervention)