Single Session Psychotherapy for Depression

(CARED Trial)

Overseen By Flavio Frohlich, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Psychotropic medication

Disqualifiers: Suicide intent, Substance use, Anorexia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Flavio Frohlich, Ph.D.

Principal Investigator

Univeristy of North Carolina Chapel Hill

Eligibility Criteria

This trial is for adults with moderate to severe depression. Participants must complete a detailed diagnostic interview, mental health questionnaires at the start and two weeks after treatment, and attend a 3-hour single session of psychotherapy.

Inclusion Criteria

Speak and understand English

Able to provide informed consent

I am willing and able to follow the study rules and attend all appointments.

Exclusion Criteria

I have not had brain surgery before.

Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as assessed by psychodiagnostic assessment

Participants must not have current active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a 3-hour, evidence-based, single session psychotherapeutic intervention with a trained clinician

1 day

1 visit (in-person)

Follow-up

Participants complete mental health questionnaires to assess changes in psychological impairment and other measures

2 weeks

1 visit (virtual)

Treatment Details

Interventions

• Single Session Psychotherapy Intervention

Trial Overview The study tests if a one-time psychotherapeutic intervention can lessen psychological distress in those with depression. It evaluates the acceptability and feasibility of this approach, as well as its effectiveness in reducing symptoms.

Participant Groups

Group I: Psychotherapy Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

The Foundation of Hope for Research and Treatment of Mental Illness

Collaborator

Trials

3

Recruited

50+