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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for suicide prevention?

Research shows that the Unified Protocol, a type of therapy used in this treatment, has been effective in reducing depression and improving emotional regulation and quality of life in people with emotional disorders. This suggests it could be helpful for suicide prevention as well. ^{1 2 3 4 5}

Is the Unified Protocol for emotional disorders safe for humans?

The Unified Protocol, a type of therapy used for various emotional disorders, has been studied in different formats, including online and group settings, and has shown to be generally safe for humans, with improvements in emotional regulation and quality of life. ^{1 2 4 5 6}

How is the Unified Protocol treatment for suicide prevention different from other treatments?

The Unified Protocol is unique because it is a flexible form of cognitive behavioral therapy that can be applied to a wide range of emotional disorders, making it adaptable for various mental health issues, including suicide prevention. It is designed to be used in different formats, such as online or in groups, which can make it more accessible and convenient for patients. ^{1 2 3 4 7}

What is the purpose of this trial?

Suicide is among the leading causes of death worldwide, and the risk of suicide is highest in the period immediately following discharge from inpatient psychiatric care.1Importantly, despite the enormously elevated risk during this period, nearly 50% of patients do not attend scheduled therapy after discharge. Even among those who do attend therapy, however, the skills learned in treatment may be difficult to use during the highly distressing time leading up to and during a suicide crisis. Most traditional treatments are not designed to be effective during a suicide crisis. In order to reduce the risk of suicidal thoughts and behaviors in general and specifically during the post-discharge period, interventions are needed that: (1) are easily adhered to and (2) are accessible and effective during a suicide crisis. As such, the purpose of this research study is to test an innovative, new intervention in order to develop an effective and accessible intervention for those at high risk for suicide

Research Team

Evan Kleiman

Principal Investigator

Rutgers, The State University of New Jersey

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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) 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]

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]

References

1. Argentina 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 [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial. [2022]

4. England 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. [2022]

5. England 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. [2019]

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

Efficacy of the unified protocol for transdiagnostic cognitive-behavioral treatment for depressive and anxiety disorders: a randomized controlled trial. [2023]

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

A systematic review of Unified Protocol applications with adult populations: Facilitating widespread dissemination via adaptability. [2021]