Psychotherapy Feasibility Pilot of the Carolina Recovery From Depression Protocol

NCT ID: NCT06590038

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-04-24

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

Conditions

Depression, Unipolar

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Psychotherapy Arm

Group Type: EXPERIMENTAL

Single Session Psychotherapy Intervention

Intervention Type: BEHAVIORAL

This is a single session intervention which incorporates elements from second- and third wave psychotherapies (Acceptance and Commitment Therapy and Behavioral Activation), as well as basic psychoeducation. Session will take approximately three hours in total, with the option for breaks between blocks of session.

Interventions

Single Session Psychotherapy Intervention

This is a single session intervention which incorporates elements from second- and third wave psychotherapies (Acceptance and Commitment Therapy and Behavioral Activation), as well as basic psychoeducation. Session will take approximately three hours in total, with the option for breaks between blocks of session.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Foundation of Hope for Research and Treatment of Mental Illness

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flavio Frohlich, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Univeristy of North Carolina Chapel Hill

Locations

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

23-1988

Identifier Type: -

Identifier Source: org_study_id