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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a single session of psychotherapy can help adults with moderate depression. Researchers aim to determine if this approach is easy to use and effective in reducing symptoms. Participants will engage in a 3-hour therapy session and complete mental health questionnaires before and after. This trial suits adults diagnosed with major depressive disorder who experience moderate symptoms affecting daily life. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

If you are taking psychotropic medication, you must be on a stable dose for at least 4 weeks and not plan to change the dose in the next 4 weeks. Otherwise, the trial does not specify if you need to stop other medications.

What prior data suggests that this single session psychotherapy intervention is safe?

Research has shown that single-session psychotherapy, a one-time therapy session, is generally safe for treating depression. Many studies have found positive effects from these sessions. For example, one study reported that 83% of reviews showed benefits for both young people and adults. Another study found that even a single online therapy session effectively reduced depression symptoms in teenagers.

These findings suggest that single-session psychotherapy is well-tolerated and doesn't cause major side effects. Specifically, one study found it safe and practical for reducing the risk of suicide. Overall, the evidence supports single-session therapy as a safe option for helping people with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Single Session Psychotherapy for depression because it offers a fast and efficient alternative to traditional therapies, which often require multiple sessions over weeks or months. This approach delivers the entire therapeutic intervention in just one session, potentially reducing the time and cost associated with treatment, making it more accessible for many people. Additionally, it aims to provide immediate support and relief, which could be especially beneficial for those with busy schedules or limited access to ongoing therapy.

What evidence suggests that this single session psychotherapy intervention might be an effective treatment for depression?

Research has shown that just one therapy session can help treat depression. In five out of six studies, people with depression experienced positive results. Another review found that therapy significantly reduced depression symptoms after just one session. Additionally, 83% of reviews reported benefits from single-session therapy for mental health issues. These findings suggest that even one therapy session, such as the Single Session Psychotherapy Intervention tested in this trial, can help reduce depression symptoms in adults. ^{1 4 6 7 8}

Who Is on the Research Team?

Flavio Frohlich, Ph.D.

Principal Investigator

Univeristy of North Carolina Chapel Hill

Are You a Good Fit for This Trial?

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

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

Able to provide informed consent

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10631081/

Effectiveness of single-session therapy for adult common ... Five of six studies showed positive results for depression, with only one reporting a positive result for anxiety.

2. sciencedirect.com sciencedirect.com/science/article/pii/S221503662400316X

Psychological interventions to prevent the onset of major ... Our individual participant data meta-analysis showed that psychological interventions significantly reduced the incidence of MDD at post-treatment and within 6 ...

3. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06544-6

Comparative effectiveness of short-term psychodynamic ... This study compares the outcome of CBT and STPP and examines the improvements in each treatment, focusing on effect sizes, reliable change, dropout rates, and ...

4. news.feinberg.northwestern.edu news.feinberg.northwestern.edu/2025/02/25/single-session-interventions-significantly-reduce-mental-health-issues-for-youth-and-adults/

Single-Session Interventions Significantly Reduce Mental ... Of the 24 systematic reviews identified, they found that 83 percent reported positive effects from single-session interventions for one or more ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/03069885.2024.2449009?src=

Efficacy of an online single-session therapy intervention in ... This study aimed to explore the efficacy of a specific type of single-session therapy based on narrative therapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8881339/

A Randomized Trial of Online Single Session Interventions ... Adolescents randomized to the BA-SSI reported significantly decreases in depression symptom severity from pre-intervention to 3-month follow-up than did ...

7. mentalhealth.bmj.com mentalhealth.bmj.com/content/28/1/e301416

Single-session intervention with and without video support ... Both groups showed significant symptom reductions at 1 month follow-up, maintained at 3 and 6 months (Cohen's d=0.68–1.08). Conclusions Adding ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032725009541

Mitigating suicide risk with a single session of virtually- ... A new virtually-delivered single-session suicide intervention was studied. Brief Skills for Safer Living was found to be safe, feasible, and acceptable.