Recovery Through Inspiration, Support, and Empowerment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-27
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services.
The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources.
The intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO).
Participants will be assigned to either Cohort A or B for 8 weeks.
Cohort A will be the intervention group with PSS and RCOs.
* Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4. * Weeks 5 and 7: One-on-one meetings with PSS for education and support. * Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks.
Cohort B will be the SOC group with no PSS or RCOs.
* Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8.
Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chief complaint of suicidal ideation, suicide attempt, depression, and/or anxiety
discharged from inpatient care or from emergency department
men and women ages 18-27
Disqualifiers
primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)
Trial design
Design model
Parallel
Treatments tested in this trial
Peer Support Services Recovery
BehavioralA program of mental health recovery through one-on-one and small group meetings with a PSS and RCOs for individuals recently discharged from an acute care psychiatric facility.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Cohort A: Intervention group with PSS and RCOsExperimental treatment 1 intervention
Group B: Cohort B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in suicidal ideation
The intervention in this study will use peer support specialist (PSS) and recovery community organization (RCO) programs to improve knowledge, awareness, and utilization of recovery and wellness programs. Connecting patients with a PSS and recovery organizations has been associated with an improvement in patient outcomes - including a change in the incidences of suicide/attempted suicide. Changes in suicide ideation and consequently the mortality from suicide will be determine by administrating the Columbia Suicide Severity Rating Scale (C-SSRS) using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. Changes is scores will be analyzed to determine the effectiveness of the intervention.
Time frame
Weeks 2, 4, 6, and 8.Secondary outcomes
1
Changes in symptoms associated with anxiety and depression
A reduction of anxiety and depression symptoms and rates of occurrence will be measured using the following standardized assessments: 1. Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms over the past two weeks. 2. The Patient Health Questionnaire (PHQ) - a self reported inventory used as a screening and diagnostic tool for depression. Responses on each assessment at each time point specified in the protocol, will be reviewed for changes (as indicating by the scoring of frequency or severity) to determine the efficacy of the intervention.
Time frame
Weeks 2, 4, 6 and 8Sponsors and contacts
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Source ClinicalTrials.gov