Single Therapy Session for Mental Health

Overseen By Anne I Roche, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Psychotic spectrum, Bipolar I and II, Severe substance use, Severe cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a single-session therapy visit, known as Single-Session Therapy, can improve mental health for individuals seeking help at the Mayo Clinic's Integrated Behavioral Health program. The goal is to assess whether this quick therapy option could benefit patients in the future. It suits those already scheduled for a consultation at Mayo Clinic Rochester who can read and speak English and have mild to moderate signs of depression or anxiety, but not severe mental health conditions. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but please confirm with the study team.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a single therapy session, so it's likely you can continue your current medications, but you should confirm with the trial coordinators.

What prior data suggests that this single-session therapy is safe for mental health patients?

Research shows that single-session therapy is generally well-received by patients. Although specific safety data for this treatment is unavailable, studies have found that single-session interventions can help with mental health issues like anxiety and depression, suggesting they are usually safe and effective. As a type of talk therapy, it doesn't use medications or involve medical procedures, often resulting in fewer side effects. Participants should talk openly with their therapists to ensure the therapy suits their needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Single-Session Therapy is unique because it offers a swift, focused approach to mental health care, unlike traditional therapies that can take weeks or months to show results. This method involves just one meeting with an Integrated Behavioral Health clinician, making it a potentially faster and more accessible option for individuals seeking immediate support. Researchers are excited about this treatment because it could significantly reduce the time and resources needed to deliver effective mental health care, especially for those who might otherwise face barriers to accessing ongoing therapy sessions.

What evidence suggests that Single-Session Therapy might be an effective treatment for mental health?

Research has shown that single-session therapy, which participants in this trial will receive, can effectively improve symptoms of common mental health issues, such as depression and anxiety. One review found that 83% of studies reported positive effects on mental health problems after just one session. For instance, a single two-hour session using cognitive behavioral techniques significantly reduced emotional distress in patients with COPD, a lung condition. This method could provide an affordable and widely available way to help people manage their mental health. Although more research is needed, early results appear promising for those seeking quick and effective mental health care. ^{1 3 4 6 7}

Who Is on the Research Team?

Anne Roche, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients seeking mental health services at Mayo Clinic's Integrated Behavioral Health program. It aims to determine if a one-time therapy session could be beneficial and of interest as a treatment option.

Inclusion Criteria

Being a patient currently scheduled for an IBH consultation session at Mayo Clinic Rochester

Exclusion Criteria

Individuals must respond < 2 to Item 9 of the PHQ-9 to be eligible for the study

Individuals diagnosed with psychotic spectrum, Bipolar I and II, or severe substance use disorder

Individuals with severe cognitive impairment per chart review

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Single-Session Therapy

Participants have a single-session therapy visit with an Integrated Behavioral Health clinician

1-1.25 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in mental health measures such as PHQ-9 and GAD-7 scores

2 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Single-Session Therapy

Trial Overview The study is testing the effectiveness of a single-session therapy visit in improving mental health outcomes for those who are part of the Integrated Behavioral Health program.

How Is the Trial Designed?

Group I: Single-Session Therapy Visit Experimental Treatment 1 Intervention

Subjects will have a single-session therapy visit with an Integrated Behavioral Health (IBH) clinician.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The ONE SHOT trial is the first study to evaluate the safety and efficacy of a single-dose stereotactic body radiation therapy (SBRT) of 19 Gy for men with localized prostate cancer, using real-time electromagnetic tracking.

Initial phase I results indicate that this urethra-sparing approach may provide a promising treatment option, although detailed efficacy and safety outcomes will need further investigation in subsequent phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fraction urethra-sparing prostate cancer SBRT: Phase I results of the ONE SHOT trial. Zilli, T., Franzese, C., Bottero, M., et al.[2020]

Single-session psychotherapy can lead to favorable outcomes for certain patients, as illustrated by case vignettes in the literature.

The effectiveness of one-session therapy may depend on specific patient characteristics and the attitudes of the therapist, suggesting that it can be a viable option in some situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-session psychotherapy. Rockwell, WJ., Pinkerton, RS.[2018]

Single-session therapy (SST) is generally perceived as helpful by clients in community-based mental health settings, leading to improvements in issues like depression, anxiety, and parenting confidence.

Despite positive outcomes, many studies on SST have methodological limitations, indicating a need for more rigorous research with standardized measures and diverse participant samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The case for single-session therapy: does the empirical evidence support the increased prevalence of this service delivery model? Hymmen, P., Stalker, CA., Cait, CA.[2013]

A single 2-hour solution-focused therapy session significantly improved mental health outcomes for children and adolescents, as reported by parents and clinicians, with medium to large effect sizes observed one month after treatment.

The study found a high satisfaction rate of 95% among respondents, supporting the recommendation of solution-focused therapy as an effective initial treatment option in child and adolescent mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of one session of therapy using a single-session therapy approach for children and adolescents with mental health problems. Perkins, R.[2015]

The Improving Access to Psychological Therapies (IAPT) service in the UK effectively monitors and reports clinical outcomes for over 537,000 patients annually, revealing that specific organizational factors, such as the number of treatment sessions and timely access to care, significantly predict better mental health outcomes.

Improvements in service organization could enhance clinical outcomes by 11-42%, indicating that how psychological therapies are delivered is as crucial as the treatments themselves, and this model could be beneficial for mental health services globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transparency about the outcomes of mental health services (IAPT approach): an analysis of public data. Clark, DM., Canvin, L., Green, J., et al.[2023]

A comprehensive risk analysis of the paraspinal SBRT workflow identified 74 potential failure modes across various phases, with treatment planning being a significant source of safety concerns.

The highest risks were linked to inadequate evaluation of previous radiotherapy, incorrect imaging registration, and undetected patient movement, prompting the implementation of targeted remedies like staff education and improved imaging protocols to enhance treatment safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. Lee, S., Lovelock, DM., Kowalski, A., et al.[2021]

Three single-session interventions (SSIs) embedded in popular social media platforms were well-received by teenagers, with high completion rates (25%-57%) and average ratings above 4 out of 5 stars, indicating strong acceptability.

The SSIs significantly reduced feelings of hopelessness and self-hate, and increased the desire to stop self-harm behaviors, demonstrating their effectiveness in improving key mental health outcomes among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Session Interventions Embedded Within Tumblr: Acceptability, Feasibility, and Utility Study. Dobias, ML., Morris, RR., Schleider, JL.[2022]

The short-term benefits of planned single session therapy (SST) for children and adolescents with mental health issues were maintained over an 18-month period, indicating its long-term efficacy.

About 60% of clients showed significant clinical improvement after just one session, but some may require additional sessions to sustain or enhance their progress, highlighting the flexibility of SST as a therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of single session therapy in child and adolescent mental health. Part 2: an 18-month follow-up study. Perkins, R., Scarlett, G.[2015]

In a study of 91 patients undergoing high-dose stereotactic body radiation therapy (SBRT) for localized prostate cancer, 6.6% experienced severe rectal toxicity at the highest dose level, with some requiring colostomy.

The risk of high-grade rectal toxicity was strongly linked to the volume of the rectal wall receiving high doses of radiation, indicating that careful dose management can help minimize this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of rectal tolerance observed in a dose-escalated phase 1-2 trial of stereotactic body radiation therapy for prostate cancer. Kim, DW., Cho, LC., Straka, C., et al.[2022]

In a study involving 40 patients who presented after deliberate self-harm, the use of solution-focused brief therapy (SFBT) showed promising results, with only one patient repeating self-harm within a week of treatment.

This suggests that SFBT may be an effective intervention for engaging individuals who self-harm, potentially reducing the likelihood of immediate repeat incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief intervention: reducing the repetition of deliberate self-harm. Wiseman, S.[2019]

Family interventions in adolescent mental health, particularly for disorders like schizophrenia, depression, and anxiety, lead to better outcomes and higher client satisfaction compared to traditional approaches.

Single session therapy (SST) is highlighted as a flexible and effective model for addressing adolescent mental disorders, providing quick access to services while minimizing challenges associated with longer family therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of family intervention in adolescent mental health. Goodman, D., Happell, B.[2007]

Single-session therapy (SST) shows promise in improving symptoms of common mental disorders (CMDs), especially depression, based on a systematic review of six randomized trials involving 298 participants.

Despite positive outcomes in five out of six studies for depression, the overall effectiveness of SST is uncertain due to a high risk of bias in the studies and a need for more robust research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of single-session therapy for adult common mental disorders: a systematic review. Kim, J., Ryu, N., Chibanda, D.[2023]

In a prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

Citations

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

Effectiveness of single-session therapy for adult common ... SST may be effective in improving CMD symptoms in adults, particularly depression. However, there is a limit to deriving definite conclusions due to a high ...

2. annualreviews.org annualreviews.org/content/journals/10.1146/annurev-clinpsy-081423-025033?TRACK=RSS

Single-Session Interventions for Mental Health Problems ... Twenty reviews (83.33%) reported significant, positive effects of SSIs for one or more outcomes (anxiety, depression, externalizing problems, ...

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1515440/full

The potential of single session intervention approaches to ... Specifically, one 2 h group interventions providing cognitive behavioral therapy significantly reduced emotional distress for COPD patients relative to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10012621/

Harnessing the Single-Session Intervention approach to ... We propose the Single-Session Intervention approach as an unexplored path to developing low-cost and scalable implementation strategies.

5. 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 ...

6. withpower.com withpower.com/trial/phase-psychotherapy-4-2024-2fc6d

Single Therapy Session for Mental Health The provided research does not contain specific safety data for Single Therapy Session for Mental Health or its variations like Single-Session Therapy, Single- ...

7. researchgate.net researchgate.net/publication/383026608_Single-Session_Interventions_for_Mental_Health_Problems_and_Service_Engagement_Umbrella_Review_of_Systematic_Reviews_and_Meta-Analyses

(PDF) Single-Session Interventions for Mental Health ... Twenty reviews (83.33%) reported significant, positive effects of SSIs for >1 outcomes (anxiety; depression; externalizing problems; eating ...