Aftercare Focus Study (AFS): A Clinical Trial to Reduce Short-Term Suicide Risk After Hospitalization

NCT04693845 | Completed Phase 2

• 1 other identifier: STUDY00010396
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Increasingly, the period after hospital admission is acknowledged as one of extremely high risk for suicidal patients. While it might be hoped that hospitalization would address and resolve suicide risk, a review of international studies shows the risk of suicide is up to 200 times higher among individuals recently discharged from hospitals vs. the general population. In response, some health care systems use an "urgent care" or "next-day appointment" (NDA) clinics for follow-up. NDAs serve as short-term crisis intervention at a specific appointment time and location so patients do not "fall through the cracks" in the care transition. Collaborative Assessment and Management of Suicidality (CAMS) is a potentially effective intervention to reduce short term suicidal risk in this transition from inpatient to outpatient treatment. To this end, this study has the following study aims: (1) Evaluate whether CAMS for suicidal NDA patients results in less suicidal behavior than TAU, (2) Evaluate whether CAMS for suicidal NDA patients results in less suicidal ideation and intent as well as improved mental health markers than TAU, and (3) Evaluate whether CAMS for suicidal NDA patients is more satisfactory to patients than TAU.

Conditions

Suicidal Ideation; Suicide, Attempted; Distress, Psychological; Quality of Life

Keywords

Suicidal Ideation; Suicide, Attempted; Distress, Psychological; Psychotherapy

Outcome Measures

Primary Outcomes (6)

• Suicidal behavior

  Suicidal behavior will be a count of a suicide + all suicide attempts + all acute hospitalizations to prevent suicide. Suicide will be determined by death records; Suicide attempts measured with the Suicide Attempt Self-Injury Count; Hospitalizations measured with the Treatment History Interview-Short Form

  Twelve months

• Suicidal ideation

  Beck Scale for Suicidal Ideation (BSS) (19 item scale scored 0-2 so scores range from 0-38 with higher scores indicating worse ideation)

  Twelve months

• Suicidal intent

  Beck Suicide Intent Scale (SIS) (17 item scale scored 0-2 so scores range from 0-34 with higher scores indicating stronger suicide intent)

  Twelve months

• Psychological Distress

  Outcome Questionnaire-45.2 (45 item scale scored 0-4 with three subscales (symptom distress, interpersonal problems, and social role functioning) and a total score ranging from 0-180 with higher scores indicating worse outcomes)

  Twelve months

• Quality of life and overall functioning

  EQ-5D (5 items scored using an algorithm to create an index value anchored at 1=full health and 0=dead)(Note the measure of this construct was changed from proposed Lehman Quality of Life Interview prior to study recruitment to reduce subject burden)

  Twelve months

• Treatment Satisfaction

  Client Satisfaction Questionnaire (8 item scale scored 1-4 resulting in a score ranging from 1-32 with higher indicating greater satisfaction with treatment)

  Through the end of study treatment, an average of 3 months

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Community Mental Health Center Next Day Appointment clinic

Behavioral: Treatment as Usual

Experimental

EXPERIMENTAL

Collaborative Assessment and Management of Suicidality (CAMS)

Behavioral: Collaborative Assessment and Management of Suicidality

Interventions

Collaborative Assessment and Management of Suicidality BEHAVIORAL

CAMS is a suicide-focused intervention that stabilizes the suicidal patient and identifies, targets, and treats patient-defined "suicidal drivers"-the problems (e.g., trauma, financial issues, relationship loss) that compel a patient to consider suicide. CAMS is theoretically agnostic, patient-centered, and can be used across different suicidal populations and clinical settings.

Experimental

Treatment as Usual BEHAVIORAL

Treatment as Usual was based on the staff, policies, and procedures of the community mental health center Next Day Appointment clinic (CMHC) affiliated with our university. Research therapists and the research psychiatrist were hired from the CMHC staff who followed standard CMHC policies and procedures.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• inpatient or emergency service admission for suicidality or suicide attempt
• lifetime suicide attempt
• referring clinician determined that the patient did not have appropriate outpatient mental health appointment in the next two weeks (other than an NDA)
• an NDA is an appropriate disposition plan
• consented to all study procedures.

You may not qualify if:

• under age 18
• insufficient English to understand the study procedures and provide informed consent
• too psychotic or manic, aggressive, or cognitively impaired such that outpatient therapy was not indicated
• patient not stable enough to be discharged home for a minimum of 24 hours prior to study treatment
• court-ordered to outpatient treatment
• patient lived an impractical distance away

Sponsors & Collaborators

• University of Washington: lead
• The Catholic University of America: collaborator
• American Foundation for Suicide Prevention: collaborator

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Katherine A Comtois, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blind to treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: August 1, 2015
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2019
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share