Brief Psychotherapy + Mobile App for Suicide Prevention

Overseen By Kate Bentley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Psychosis, Intellectual disability, Dementia, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to prevent suicide in individuals recently hospitalized for mental health reasons. The goal is to ensure therapy skills are accessible during stressful times by combining brief psychotherapy sessions with a mobile app (Suicide Prevention App). This method aims to provide support that remains easy to follow and effective, even during crises. Eligible participants should have recently been admitted to a partner hospital due to suicide risk, speak English, and own a smartphone with internet access. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this psychotherapy and mobile app intervention is safe for suicide prevention?

Research has shown that the Unified Protocol, a type of therapy, is generally easy for people to handle. This treatment addresses emotional problems and is used for various emotional disorders. Studies have found it effective for different groups, suggesting it is adaptable and safe.

While specific safety information about using the Unified Protocol to prevent suicide is lacking, it has been studied for other emotional issues. These studies report no major serious side effects, which is encouraging. This indicates that those who have tried this approach generally did not experience major problems.

In summary, the Unified Protocol appears to be a safe option for many, based on existing research. However, discussing any concerns with healthcare professionals before starting a new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Unified Protocol for suicide prevention because it integrates brief psychotherapy with a mobile app, offering a flexible and accessible approach to mental health care. Unlike traditional treatments that often require long-term therapy sessions, this method provides targeted support in just three sessions, making it more feasible for individuals with busy schedules. Additionally, the use of a mobile app allows for real-time intervention and support, which can be crucial for individuals experiencing acute distress. This combination of brief therapy and digital support aims to deliver effective, timely assistance to those in need.

What evidence suggests that this trial's treatments could be effective for suicide prevention?

Research has shown that the Unified Protocol, which participants in this trial will receive, can greatly improve symptoms of depression and anxiety. It reduces negative feelings and enhances overall quality of life. Studies have found it to be as effective as treatments focusing on specific disorders. This method teaches skills to manage emotions, proving very helpful during a crisis. Early findings suggest it might be a promising option for people at high risk of suicide. ^{1 3 6 7 8}

Who Is on the Research Team?

Evan Kleiman

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

This trial is for adults over 18 who were admitted to certain hospital units due to suicide risk, can speak and write English fluently, and own a smartphone with internet. It aims to help those at high risk for suicide after they leave the hospital.

Inclusion Criteria

The ability to speak and write English fluently

Ownership of and consistent access to an internet-capable smartphone (e.g., an iPhone or Android phone)

Admission to eligible units in our partner hospital with a reason for admission related to suicide risk

Exclusion Criteria

The presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Unified Protocol-based treatment, with three sessions and use of a mobile app to manage suicidal thoughts and behaviors

4 weeks

3 sessions (in-person)

Follow-up

Participants are monitored for changes in suicidal thoughts and self-efficacy for managing negative emotions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile App
• Unified Protocol

Trial Overview The study tests an innovative intervention combining brief psychotherapy with a mobile app designed to be easily used and effective during periods of distress, particularly following psychiatric discharge.

How Is the Trial Designed?

Group I: Unified Protocol Experimental Treatment 1 Intervention

Unified Protocol-based treatment, with three sessions

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The unified protocol (UP) significantly reduced depressive symptoms in patients with depressive and/or anxiety disorders over a 20-week period, showing a mean change difference of -3.99 on the GRID-Hamilton depression rating scale compared to the wait-list group.

Patients receiving UP also experienced significant improvements in anxiety symptoms and overall clinical impressions, with these benefits maintained even at 43 weeks, and no serious adverse events were reported, indicating a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the unified protocol for transdiagnostic cognitive-behavioral treatment for depressive and anxiety disorders: a randomized controlled trial. Ito, M., Horikoshi, M., Kato, N., et al.[2023]

In a study involving 291 patients with various anxiety and depression disorders, the group-delivered Unified Protocol (UP) showed non-inferior efficacy compared to diagnosis-specific cognitive behavioral therapy (dCBT) at the end of treatment, indicating it can be an effective alternative.

Both treatment approaches resulted in similar client satisfaction and outcomes regarding response, remission, and attrition rates, suggesting that UP could be a practical option for outpatient mental health services, although further research is needed on its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial. Reinholt, N., Hvenegaard, M., Christensen, AB., et al.[2022]

The Unified Protocol (UP) for treating emotional disorders has shown promising results in a virtual group format, with significant improvements in depression, emotional regulation, and quality of life in a previous pilot study of 7 subjects.

After three months, the positive effects of the UP were maintained, indicating its potential for long-term efficacy in teletherapy settings, although more extensive research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study Celleri, M., Cremades, CF., Rojas, L., et al.[2023]

The Unified Protocol (UP) is a flexible, evidence-based treatment that has been applied to a wide variety of emotional disorders, including anxiety, depression, and substance use, as well as non-diagnosable issues like self-injury and sexual minority stress, based on a review of 77 studies.

The strongest evidence for the UP's effectiveness is found among Caucasian females in the U.S. with anxiety or depressive disorders, but many studies are preliminary, indicating a need for further research to confirm its efficacy across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of Unified Protocol applications with adult populations: Facilitating widespread dissemination via adaptability. Cassiello-Robbins, C., Southward, MW., Tirpak, JW., et al.[2021]

A brief online version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was tested with 19 young adults, showing that 72% attended at least four out of five sessions, indicating good feasibility for this format.

Participants reported that key concepts from the therapy, like understanding emotions and mindfulness, were useful in their daily lives, and there was a significant reduction in anxiety-related life impairment at the 12-week follow-up compared to baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. Dimitropoulos, G., Lindenbach, D., Rowbotham, M., et al.[2023]

The Unified Protocol (UP) for treating emotional disorders was found to be as effective as established single disorder protocols (SDPs) in reducing symptoms of co-occurring emotional disorders among 179 adults, with significant improvements observed from baseline to post-treatment and at 12-month follow-up.

Both treatment approaches led to large reductions in symptoms of generalized anxiety, social anxiety, and depression, indicating that the UP is a viable and potentially more cost-effective option for treating multiple emotional disorders simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. Steele, SJ., Farchione, TJ., Cassiello-Robbins, C., et al.[2019]

The Unified Protocol (UP) for treating emotional disorders was found to be more effective than traditional treatment as usual (TAU) in improving depression, anxiety, and quality of life among 488 participants in a public mental health system in Spain.

Improvements from the UP treatment were sustained over time, with significant benefits observed even at 6 and 9 months post-treatment, highlighting its potential for long-term effectiveness in managing emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Unified Protocol for transdiagnostic treatment of emotional disorders in group format in Spain: Results from a randomized controlled trial with 6-months follow-up. Osma, J., Peris-Baquero, O., Suso-Ribera, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5710228/

The Unified Protocol for Transdiagnostic Treatment ... This randomized clinical equivalence trial examines whether the Unified Protocol is at least as efficacious as single-disorder protocols in the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724015295

Efficacy of the unified protocol for transdiagnostic treatment ... Significant improvements in negative affect, emotional dysregulation, neuroticism, extraversion, functioning, and quality of life were also ...

3. unifiedprotocol.com unifiedprotocol.com/research/

Research Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: Protocol development and initial outcome data. Cognitive and Behavioral Practice ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3383087/

Unified Protocol for Transdiagnostic Treatment of ... The UP resulted in significant improvement on measures of clinical severity, general symptoms of depression and anxiety, levels of negative and positive affect, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06928480

Effectiveness and Acceptability of the Unified Protocol for ... The main objective of this randomized controlled trial is to evaluate the effectiveness and acceptability of the Unified Protocol (UP) in an online group format ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000578942400056X

State of the Science: The Unified Protocol for ... The UP is an effective treatment for emotional disorders and neuroticism. The UP can address a variety of problems across different cultures and identities.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04837521

Five Session Unified Protocol for Older Adults With ... The primary aim of the proposed study is to adapt a 5-session version of the UP for use with older adults reporting emotional distress and reduced engagement in ...

8. link.springer.com link.springer.com/article/10.1007/s12144-024-06159-2

Is the Unified Protocol for transdiagnostic treatment of ... The Unified Protocol (UP) is a transdiagnostic treatment specially designed to address EDs with growing evidence about its cost-effectiveness.