Group and Phone Follow-Up for Emotional Crisis

Recruiting at 2 trial locations

Overseen By Jennifer Lockman, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Rochester

Disqualifiers: Under 18, Non-English, Psychotic, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement), designed to assist individuals during and after a suicidal crisis. The goal is to determine if group discussions and follow-up calls enhance recovery more effectively than standard safety planning alone. Participants will receive either the usual care or the THRIVE program for additional support. The trial seeks individuals admitted to a crisis stabilization center due to suicidal thoughts who can communicate in English and access a phone for follow-up. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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 is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the THRIVE program is safe and well-liked. Past studies found THRIVE effective and helpful in crisis stabilization centers, indicating that participants generally manage it well and find it beneficial. No major reports of negative side effects have emerged.

THRIVE helps people understand their crisis and plan for recovery through group discussions and follow-up coaching calls. While more research is always useful, current evidence suggests that THRIVE is a safe choice for those experiencing an emotional crisis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the THRIVE program because it offers a unique approach to emotional crisis recovery by emphasizing community connection and personal growth. Unlike standard care, which often focuses solely on safety planning and discharge protocols, THRIVE incorporates group reflections on themes like "giving and belonging," which can foster a deeper sense of connection and support. Additionally, THRIVE includes follow-up coaching calls to reinforce and troubleshoot the personalized plans, providing ongoing support and increasing the likelihood of a successful recovery. This method aims to not only manage immediate crises but also promote long-term emotional resilience and engagement.

What evidence suggests that this trial's treatments could be effective for emotional crises?

This trial will compare two approaches: Discharge/Safety Planning alone and the THRIVE program combined with Discharge/Safety Planning. Studies have shown that THRIVE can help people better understand their suicidal crisis. It may reduce suicidal thoughts and aid recovery more effectively than usual care. Research suggests that THRIVE emphasizes hope, recovery, and building connections, which can help people move forward after a crisis. Initial findings indicate that participants find THRIVE practical and well-liked, making it a promising option for those in crisis stabilization centers. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This study is for adults experiencing an emotional crisis or suicidal thoughts who are admitted to a Crisis Stabilization Center (CSC). Participants must be able to communicate in English and provide emergency contact information. It's not suitable for individuals under 18, those with acute psychiatric instability like psychosis, or anyone unable to understand the study.

Inclusion Criteria

Admission to CSC with suicidal crisis, as defined by active suicide ideation ascertained by the Columbia Suicide-Severity Rating scale, which the sites already routinely administer

Ability and willingness to provide information for and permission to contact one person in case of emergency or inability to reach the participant for follow-up

Exclusion Criteria

I cannot communicate in English with the researcher.

Acute psychiatric instability (e.g., psychotic symptoms). Most patients with psychosis are transferred to Emergency Departments instead of CSCs, so we do not expect many exclusions based on this criterion.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Crisis Stabilization Center Stay

Participants engage in a 'belonging and giving' group during their stay at the Crisis Stabilization Center

Duration not specified

In-person stay at CSC

Post-Discharge Follow-up

Participants receive recovery coaching calls for 4 weeks post-discharge to reinforce and troubleshoot plans for community connection and treatment

4 weeks

3-4 coaching calls (phone)

Extended Follow-up

Participants are monitored for treatment initiation, belongingness, and burdensomeness at 1 and 3 months post-discharge

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Discharge / Safety Planning
• THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement)

Trial Overview

The trial is testing 'THRIVE', a follow-up care program designed for people after they've had a suicidal crisis. It includes personalized recovery planning and phone check-ins post-discharge from CSCs. The goal is to see if this approach helps people feel better compared to usual safety planning.

How Is the Trial Designed?

Group I: THRIVE + Discharge / Safety Planning Experimental Treatment 1 Intervention

Participants assigned to the intervention condition will receive THRIVE Crisis Recovery and Care Transition Program, which consists of group-based reflections on "giving and belonging" and a plan for community connection and treatment, followed by 3-4 coaching calls to reinforce and troubleshoot the plans.

Group II: Discharge / Safety Planning Alone Active Control 1 Intervention

Participants assigned to the control condition will receive Discharge/Safety Planning as it is practiced by Connections Health Solutions per industry best practices.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Centerstone Research Institute

Collaborator

Trials

4

Recruited

1,700+

Published Research Related to This Trial

In a study involving 353 women, the Seeking Safety treatment, designed for those with substance use disorder and PTSD, showed significant reductions in PTSD symptoms but did not outperform the Women's Health Education group in effectiveness.

Both treatments did not lead to significant improvements in substance use outcomes, indicating a need for better strategies in community-based treatments for women facing these co-occurring issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders. Hien, DA., Wells, EA., Jiang, H., et al.[2022]

In a study of 420 veterans with PTSD, those receiving Seeking Safety (SS) had a higher treatment completion rate (89%) compared to those receiving cognitive processing therapy (CPT) (50%), indicating SS may be more acceptable for veterans.

However, veterans who completed CPT showed significantly greater reductions in PTSD symptoms, as measured by the PTSD checklist, suggesting that while SS is easier to complete, CPT may be more effective in reducing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. Baig, MR., Ouyang, S., Mata-Galán, E., et al.[2021]

In a study of 269 patients in a partial hospital setting, higher levels of personal growth initiative (PGI) and valuing personal growth (VPG) were linked to lower depression and higher psychological well-being.

While baseline levels of PGI and VPG did not predict treatment outcomes, increases in these measures during treatment were associated with significant improvements in depression and well-being, suggesting that fostering personal growth can enhance therapeutic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between personal growth and psychological functioning in individuals treated in a partial hospital setting. Danitz, SB., Orsillo, SM., Beard, C., et al.[2019]

The study involved 80 patients who experienced organ loss, and those who participated in one-to-one interactions combined with group psychotherapy showed significant improvements in hope, reduced anxiety, and enhanced self-care practices compared to a control group.

This integrative approach not only boosted patients' self-confidence in managing their care but also facilitated better understanding and acceptance of their experiences through shared feelings and self-exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the one-to-one interaction process with group supportive psychotherapy on the levels of hope, anxiety and self-care practice for patients that have experienced organ loss: an alternative nursing care model. Ruchiwit, M.[2012]

A pilot study involving 18 veterans showed that the Seeking Safety treatment, a cognitive-behavioral approach for those with both substance use disorders and PTSD, led to significant symptom reduction after 14 months of clinician training.

The treatment was well-received by clinicians, indicating its acceptability in a VA setting, although there are challenges to making it a standard part of routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and feasibility of a cognitive-behavioral treatment for substance use disorders and posttraumatic stress disorder in the Veterans Administration. Cook, JM., Walser, RD., Kane, V., et al.[2022]

The 'Women's Safety in Recovery' group therapy model is designed specifically for inpatients and partial hospital patients with histories of childhood sexual abuse, focusing on trauma recovery and coping with current life stressors.

This therapy consists of three flexible one-week modules that allow patients to join or leave at any time, incorporating psychoeducation, problem-solving skills, and supportive discussions to enhance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's safety in recovery: group therapy for patients with a history of childhood sexual abuse. Talbot, NL., Houghtalen, RP., Cyrulik, S., et al.[2004]

In a study of 192 psychiatric and chemically dependent inpatients, hope levels measured by the Miller Hope Scale were significantly lower at admission compared to established norms, indicating a need for interventions to enhance hope in these populations.

By the time of discharge, both groups showed improved hope scores that approached the normative levels, suggesting that treatment may effectively enhance hope as a healing force in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of hope in psychiatric and chemically dependent patients. Holdcraft, C., Williamson, C.[2019]

Support groups focusing on self-help and mutual support can be a powerful intervention for adult survivors of child sexual abuse, helping them address both interpersonal and intrapersonal issues stemming from their experiences.

The article highlights the importance of the group leader's role, a time-limited approach, and the stages of group development in effectively facilitating these support groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of support groups with adult female survivors of child sexual abuse. Knight, C.[2004]

A pilot study involving 14 male veterans from OEF/OIF suggests that the Seeking Safety (SS) therapy can significantly reduce alcohol use, PTSD symptoms, and depression, even when less than the full treatment model is used.

Key features of SS, such as case management and community resource emphasis, were particularly beneficial for veterans, addressing their unique challenges in reintegrating into civilian life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of seeking safety therapy with OEF/OIF veterans. Norman, SB., Wilkins, KC., Tapert, SF., et al.[2021]

The Seeking Safety intervention, a cognitive-behavioral therapy designed for homeless women veterans with substance abuse and trauma histories, showed significant improvements in employment, social support, and symptoms of psychiatric distress over one year, particularly in PTSD symptoms.

Despite these positive outcomes, the Seeking Safety cohort reported a higher likelihood of drug use in the past 30 days, indicating a complex relationship between treatment and substance use that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the seeking safety program on clinical outcomes among homeless female veterans with psychiatric disorders. Desai, RA., Harpaz-Rotem, I., Najavits, LM., et al.[2022]

An innovative crisis group intervention at Strong Memorial Hospital demonstrated that process interventions can enhance group interaction while maintaining a focus on crisis management, based on over a year of operation.

The group also served as an effective assessment tool for individual capabilities in long-term group work, with 18 out of 20 members successfully referred to other groups, indicating its reliability and potential for therapeutic growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying Yalom's principles to crisis work...some intriguing results. Chen, ME.[2009]

In open-ended inpatient psychotherapy groups, there are four distinct stages of group development: rebeginning, subgrouping, work phase, and termination, each focusing on different boundary issues.

As group members progress through these stages, they move from establishing separateness to forming supportive relationships, with specific therapeutic interventions tailored to each stage to enhance group effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systems model of short-term, open-ended group therapy. Beeber, AR.[2019]

An 8-session outpatient psychotherapy group focused on crisis intervention led to significant improvements in anxiety and depression symptoms among participants, with even greater benefits observed at a 1-year follow-up.

The success of the therapy is thought to be linked to the specific characteristics of the patients and the effective structure of the group, which facilitated better management of crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The crisis group--an outcome study. Donovan, JM., Bennett, MJ., McElroy, CM.[2019]

Implementing recovery-oriented interventions in an inpatient psychiatric setting led to a more than 50% reduction in the use of restraints and seclusions, indicating a safer environment for patients.

The quality improvement project, which involved 352 patients and 27 staff, also resulted in increased staff satisfaction, suggesting that recovery-oriented care benefits both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transformation to a recovery-oriented model of care on a veterans administration inpatient unit. Zuehlke, JB., Kotecki, RM., Kern, S., et al.[2018]

The article proposes that fostering Hope should be a key goal in the clinician-patient relationship, as it helps both parties find meaning in the treatment journey.

A new 'Hope Checklist' for clinicians is introduced, which includes steps to clarify patient goals, demonstrate support, and outline realistic pathways to enhance patient confidence in achieving positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Giving Hope as a High Reliability Function of Health Care. Mylod, D., Lee, TH.[2023]

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Toward Hope, Recovery, Interpersonal Relationships, Values, and Engagement (THRIVE) is a suite of psychotherapy and peer- based interventions ...