Group Interventions for Suicidal African Americans

Not Applicable

Withdrawn

• Conditions: Suicidal Ideation; Depression; Mental Illness; Suicide
• Interventions: Behavioral: Outpatient counseling and support groups; Behavioral: 10 weekly group meetings

• Registration Number: NCT02227160
• Lead Sponsor: Emory University

Brief Summary

The investigator is conducting a hybrid efficacy-effectiveness randomized controlled trial with low-income African American suicide attempters. Guided by the Theory of Triadic Influence (TTI), this pilot randomized controlled trial aims:

1. to determine if psychosocial group intervention (PGI) is more effective than enhanced treatment as usual (ETAU) in reducing suicidal behavior (ideation, attempts; primary outcome) and improving its correlates (depressive symptoms, hopelessness, quality of life) (secondary outcomes) in low-income African Americans with a recent attempt.

2. to determine if PGI is more effective than ETAU at bolstering intrapersonal (I), social/situational (SS), and cultural/environmental (CE) risk and protective factors that mediate the condition-suicidal behavior and correlates link and thus serve as mechanisms of change.

3. to determine I, SS, and CE variables that moderate the condition-suicidal behavior link and thus serve as predictors of intervention outcome.

Hypothesis for Aim 1: At post-intervention and follow-up, PGI participants will evidence greater improvements in suicidal behavior and its correlates than those in ETAU.

Hypothesis for Aim 2: Changes in these risk and protective factors will account for condition effects on outcomes: (1) psychological distress, aggression, impulsivity, substance abuse, low self-esteem, and suicide acceptability (I-risk); (2) perceived burdensomeness and thwarted belongingness, relationship discord, intimate partner violence perpetration and victimization (SS-risk); (3) access to a weapon and barriers to service utilization (CE-risk); (4) reasons for living, optimism, positive ethnic identity, effective coping, and spiritual well-being (I-protective); (5) overall family health and social support from family and friends (SS-protective); and (6) religious involvement and effectiveness of obtaining resources (CE-protective).

Hypothesis for Aim 3: Individuals (1) having fewer Diagnostic and Statistical Manual of Mental Disorders (DSM) disorders and attachment styles characterized by positivity toward the self and others (I); (2) children and more limited trauma histories (SS); and (3) more daily hassles and less exposure to community disorder (CE) will evidence greater reductions in suicidal behavior and its correlates and greater enhancements in quality of life at post-intervention and follow-up.

Detailed Description

Attention will be paid to Theory of Triadic Influence intrapersonal, social/ situational, and cultural/ environmental risk and protective factors that impact outcomes. The central hypothesis is that compared to enhanced treatment as usual, through targeting Theory of Triadic Influence-risk and protective factors the culturally-informed, Theory of Triadic Influence-driven, empowerment based psychosocial group intervention will more positively alter trajectories in suicidal behaviors and its correlates. The rationale is that upon study completion, if data support the psychosocial group intervention value, they will facilitate our long-term goal of disseminating evidence-based culturally-relevant interventions.

In order to test the hypothesis that at post-intervention and 6 and 12-month follow-up, compared to individuals in ETAU, those in the PGI will endorse less I, SS, and CE risk factors, reduced suicidal ideation, depressive symptoms, and hopelessness, and greater levels of I, SS, and CE protective factors as well as increased quality of life, the study procedures will be as follows: Male and female participants between the ages of 18-64 will be recruited in the medical and psychiatric emergency rooms at GHS. Once the individual has been medically cleared and has provided informed consent, he/she will be screened for study appropriateness by trained project team members (10-20 minutes). If he/she meets inclusion criteria, study participation will include a 3-hour interview. All study measures will be read to each participant. Measures will assess background variables, suicidal behavior, depressive symptoms, hopelessness, quality of life, and I, SS, and CE risk and protective factors. All measures are psychometrically sound and appropriate for use with an African American population. Once the interview is over, the participant will be randomly assigned to either the PGI (10 group therapy sessions) or the ETAU condition (participation in a support group focused on suicidal behaviors plus suicidal behavior monitoring and help with accessing resources). The PGI, conducted in accord with the culturally informed, TTI-guided, and empowerment based group protocol, and the support group will be unstructured; both groups will last 120 minutes. Following the completion of the PGI or ETAU condition, the individuals will be assessed at post-intervention (3 hours), and at 6 month and 12 month follow-ups (3 hours each). To increase retention and reduce suicide risk, reminder phone calls will be made and texts sent on Relieflink, a suicide prevention app that received 1st prize in an App Challenge sponsored by Substance Abuse and Mental Health Services Administration.

Study Timeline

• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-27
• Study Start: 2016-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 18 - 64 yrs old
• patients who seek treatment at Grady Health System (GHS) after a suicide attempt
• African American
• speak English

Read More

Exclusion Criteria

• cognitive impairments
• medical instability

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Outpatient counseling and support groups	Subjects will seek outpatient counseling and support groups only
Psychosocial group intervention	10 weekly group meetings	Subjects will seek outpatient counseling, support groups, in addition to 10 weekly group meetings
Psychosocial group intervention	Outpatient counseling and support groups	Subjects will seek outpatient counseling, support groups, in addition to 10 weekly group meetings

Primary Outcome Measures

Name	Time	Method
Change in scores on Beck Scale for Suicidal Ideation	Baseline, post-therapy, 6 months and 12 months after therapy	Beck Scale for Suicidal Ideation is a 21-item instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	12 months	Intervention Satisfaction Survey (ISS)
Change in scores on Beck Hopelessness Scale	Baseline, post-therapy, 6 months and 12 months after therapy	Beck Hopelessness Scale is a 20-item true-false self-report scale that measures the level of negative expectations about the future held by respondents
Change in scores on Beck Depression Inventory - II	Baseline, post-therapy, 6 months and 12 months after therapy	Beck Depression Inventory - II is a 21-item, self-reported questionnaire used to assess characteristics of depression.
Change in scores on WHO Quality of Life Brief Instrument	Baseline, post-therapy, 6 months and 12 months after therapy	The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.

Trial Locations

Locations (1)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States