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

34 Participants Needed

Trial Summary

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 data supports the idea that Single Therapy Session for Mental Health is an effective treatment?

The available research shows that Single Therapy Session (SST) can be effective for treating mental health problems in children and adolescents. One study found that after just one session, there was a significant improvement in mental health symptoms according to parents and clinicians, with medium to large improvements observed. Additionally, 95% of respondents were satisfied with the service. This suggests that SST can be a good initial treatment choice for young people with mental health issues. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Single-Session Therapy for mental health?

Research shows that Single-Session Therapy (SST) can lead to significant improvements in mental health for children and adolescents, with medium to large effect sizes reported after just one session. Parents and clinicians observed noticeable improvements in mental health symptoms, and 95% of participants were satisfied with the service. ^{1 2 3 4 6}

What safety data exists for 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-Session Intervention, SST, or Single-Session Integrated CBT. The studies mentioned focus on different interventions, such as solution-focused brief therapy for self-harm and various forms of stereotactic body radiotherapy for prostate cancer, which are unrelated to the mental health treatments in question. ^{7 8 9 10 11}

Is Single-Session Therapy generally safe for mental health treatment?

The research on Solution-Focused Brief Therapy (a type of Single-Session Therapy) for people who self-harm suggests it is generally safe, as only one out of 40 patients repeated self-harm within a week after the session. ^{7 8 9 10 11}

Is Single-Session Therapy a promising treatment for mental health?

Yes, Single-Session Therapy (SST) is a promising treatment for mental health. It is effective in providing quick access to mental health support, especially for teenagers and adolescents. SST can be easily accessed online, making it convenient for those seeking help. It has shown positive results in treating various mental health issues and is flexible enough to be used in different settings, including family therapy. SST helps fill the gap in mental health care by offering a quick and effective solution. ^{2 5 6 12 13}

How is Single-Session Therapy different from other mental health treatments?

Single-Session Therapy (SST) is unique because it provides mental health support in just one session, making it a quick and accessible option compared to traditional therapies that require multiple sessions. It is particularly effective for teenagers and can be delivered online, making it easily accessible on popular social platforms. ^{2 5 6 12 13}

What is the purpose of this trial?

The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future.

Research Team

Anne Roche, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. England 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. [2015]

2. England 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. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Single-session psychotherapy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Transparency about the outcomes of mental health services (IAPT approach): an analysis of public data. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of single-session therapy for adult common mental disorders: a systematic review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The case for single-session therapy: does the empirical evidence support the increased prevalence of this service delivery model? [2013]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Ireland pubmed.ncbi.nlm.nih.gov

Single fraction urethra-sparing prostate cancer SBRT: Phase I results of the ONE SHOT trial. [2020]

9. United States 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. [2022]

10. Germany 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. [2021]

12. Canada pubmed.ncbi.nlm.nih.gov

Single-Session Interventions Embedded Within Tumblr: Acceptability, Feasibility, and Utility Study. [2022]

13. England pubmed.ncbi.nlm.nih.gov

The efficacy of family intervention in adolescent mental health. [2007]