Psychoeducational Intervention for Suicide Prevention in Abusive Relationships

Overseen By Barbara D'Orio, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Low MMSE, Low REALM, Psychosis

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 10 weeks

397 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is psychoeducational intervention generally safe for humans?

Psychoeducational interventions have been used safely in various conditions, such as schizophrenia and cancer, and are known to help improve understanding and coping skills without significant safety concerns. ^{1 2 3 4 5}

How is the Psychoeducational Intervention (PEI) treatment different from other treatments for suicide prevention in abusive relationships?

Psychoeducational Intervention (PEI) is unique because it combines education about mental health with cognitive-behavioral strategies to empower individuals to understand and manage their situation better. Unlike other treatments, it focuses on providing knowledge and skills to both patients and their families, aiming to improve adherence and reduce the risk of future suicide attempts. ^{2 4 6 7 8}

What data supports the effectiveness of the treatment Enhanced treatment as usual (ETAU) and Psychoeducational intervention (PEI) for suicide prevention in abusive relationships?

Research shows that psychoeducational interventions (PEIs) can improve knowledge and health outcomes in people with schizophrenia and psychotic disorders, and they are effective in reducing relapse rates when involving family members. This suggests that PEIs might also be beneficial in other mental health contexts, such as suicide prevention in abusive relationships. ^{1 3 9 10 11}

Who Is on the Research Team?

Nadine J. Kaslow, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for African American women who have attempted suicide and experienced domestic violence within the last year. They must be seeking help at Grady Health System, with adequate mental status and literacy levels as measured by specific tests.

Inclusion Criteria

Seeks services at Grady Health System

I am an African-American female.

Suicide attempt within the 12 months prior to study entry

Exclusion Criteria

Score of less than 22 on Mini Mental Status Exam (MMSE)

Score of less than 18 on Rapid Estimate of Adult Literacy in Medicine (REALM)

Acutely psychotic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants complete a 2-hour survey about life events, concerns, and feelings

1 week

1 visit (in-person)

Treatment

Participants are randomly assigned to either psychoeducational intervention or enhanced treatment as usual. PEI group attends 10 weekly, 90-minute group sessions.

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with surveys at Week 10, and Months 6 and 12 post-treatment

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced treatment as usual (ETAU)
• Psychoeducational intervention (PEI)

Trial Overview The study compares usual treatment methods against special group sessions designed to empower these women, focusing on their cultural needs. The goal is to see if these empowerment sessions are more effective in helping them.

How Is the Trial Designed?

Group I: Psychoeducational intervention (PEI) Experimental Treatment 1 Intervention

Culturally competent group empowerment psychoeducational treatment (group intervention that is culturally informed and educational in nature)

Group II: Enhanced Treatment as Usual Active Control 1 Intervention

Enhanced treatment as usual that includes an adherence protocol (regular care at the hospital plus an adherence protocol)

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Psycho-educational interventions (PEIs) significantly improved the knowledge level of schizophrenia among patients and their caregivers across various follow-up periods, based on a review of 28 studies conducted from 1999 to 2015.

PEIs were more effective than standard treatment in enhancing health-related outcomes for individuals with schizophrenia, suggesting they should be integrated into mental health care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducational Interventions for People with Schizophrenia: Findings from the Systematic Reviews. Hasan, AA., Belkum, CV.[2020]

In a study of 75 patients (49 with depression and 26 with psychosis), psychoeducation (PE) significantly improved mental health quality and reduced psychological pressure more in depressive patients than in psychotic patients.

Both groups benefited from PE, but depressive patients reported higher satisfaction levels, indicating that tailored PE content may be necessary for psychotic patients to enhance their outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychoeducation and quality of life: an amplification of the evaluation study in Graz (Part 2). A comparison of psychoeducation with psychotic and depressive patients]. Kreiner, B., Baranyi, A., Stepan, A., et al.[2021]

A randomized controlled trial with 40 breast cancer patients showed that psychoeducational interventions (PEIs) significantly improved anxiety, depression, resilience, and quality of life, particularly noticeable two weeks after the final chemotherapy session.

The PEI program, which included educational materials and self-assessments, enhanced patients' disease-specific care knowledge and self-efficacy during chemotherapy, indicating its potential as an effective supportive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Psychoeducational Intervention in Patients With Breast Cancer Undergoing Chemotherapy. Wu, PH., Chen, SW., Huang, WT., et al.[2022]

Psychoeducation for patients with psychosis, especially when combined with family involvement, significantly improves treatment adherence and social functioning.

Family psychoeducation alone can effectively reduce relapse rates in psychosis, achieving results comparable to those of antipsychotic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychoeducation of patients and their family members during episode psychosis]. Hodé, Y.[2014]

A 20-session group psychoeducation program significantly increased knowledge among 99 patients with psychotic disorders, with improvements noted immediately and sustained for at least 6 months after the program.

Coping skills improved during the program but did not show lasting effects beyond the immediate post-program period, indicating that while psychoeducation enhances knowledge, its impact on coping may be temporary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducation for patients with a psychotic disorder: effects on knowledge and coping. Bossema, ER., de Haar, CA., Westerhuis, W., et al.[2021]

The FOCUS Program, adapted for delivery by social workers at a Cancer Support Community, significantly improved quality of life and self-efficacy for 34 cancer survivor-caregiver dyads, showing effectiveness similar to previous clinical trials.

Despite challenges in recruiting participants (60% enrollment), the program maintained high retention (92%) and fidelity (94%), indicating that it can be feasibly implemented in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Psychoeducational Program for Cancer Survivors and Family Caregivers at a Cancer Support Community Affiliate: A Pilot Effectiveness Study. Dockham, B., Schafenacker, A., Yoon, H., et al.[2017]

A randomized multicenter study in Munich demonstrated that a psychoeducation program significantly reduced rehospitalization rates for patients with schizophrenia from 58% to 41% over two years.

The program also led to a decrease in the number of days spent in the hospital, from 78 to 39 days, highlighting its efficacy in improving patient outcomes and supporting the need for such programs to be available to all affected individuals and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducation: a basic psychotherapeutic intervention for patients with schizophrenia and their families. Bäuml, J., Froböse, T., Kraemer, S., et al.[2022]

Family psychoeducation is an effective, evidence-based practice that helps reduce relapse rates and supports recovery in individuals with mental illness by providing emotional support, education, and problem-solving skills.

Despite its proven benefits, the implementation of family psychoeducation in routine mental health care is limited due to various barriers, including attitudes, knowledge gaps, and systemic issues, highlighting the need for consensus-building and training among all stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based practices for services to families of people with psychiatric disabilities. Dixon, L., McFarlane, WR., Lefley, H., et al.[2005]

The PEPSUI program, a 10-week psychoeducational intervention for patients who attempted suicide, showed promising results in improving participants' perceptions of mental health services and equipping them with skills for stress management and distress tolerance.

Qualitative feedback indicated that the PEPSUI program led to deeper life changes, such as enhanced mindfulness, improved decision-making, and a greater sense of meaning and control in life, suggesting its potential effectiveness in suicide prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PEPSUI, a Psychoeducational Program for the Management of Suicidal Patients: A Qualitative Study From a Randomized Controlled Trial. Henrion, A., Courtet, P., Arpon-Brand, V., et al.[2022]

Psycho-educational programs for suicide prevention in students aged 14 to 18 significantly improved knowledge about suicide and positively influenced attitudes towards suicidal individuals.

However, these programs did not have an impact on coping styles or levels of hopelessness, indicating that while they can enhance understanding and attitudes, they may not address all aspects of mental health related to suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention in adolescents: a controlled study of the effectiveness of a school-based psycho-educational program. Portzky, G., van Heeringen, K.[2015]

Suicide prevention is a public health priority, and various interventions have been evaluated, including training healthcare workers in assessing suicidal risk and managing mental disorders, which are crucial for effective prevention.

Effective prevention programs should combine multiple strategies that address various known risk factors for suicide, highlighting the important role of clinicians in these efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Suicide prevention: How to act?] Pouquet, M., Niare, D., Guerrisi, C., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Psychoeducational Interventions for People with Schizophrenia: Findings from the Systematic Reviews. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Psychoeducation and quality of life: an amplification of the evaluation study in Graz (Part 2). A comparison of psychoeducation with psychotic and depressive patients]. [2021]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Effects of a Psychoeducational Intervention in Patients With Breast Cancer Undergoing Chemotherapy. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Psychoeducation of patients and their family members during episode psychosis]. [2014]

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

Psychoeducation for patients with a psychotic disorder: effects on knowledge and coping. [2021]

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

Implementation of a Psychoeducational Program for Cancer Survivors and Family Caregivers at a Cancer Support Community Affiliate: A Pilot Effectiveness Study. [2017]

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

Psychoeducation: a basic psychotherapeutic intervention for patients with schizophrenia and their families. [2022]

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

Evidence-based practices for services to families of people with psychiatric disabilities. [2005]

9. Switzerland pubmed.ncbi.nlm.nih.gov

PEPSUI, a Psychoeducational Program for the Management of Suicidal Patients: A Qualitative Study From a Randomized Controlled Trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Suicide prevention in adolescents: a controlled study of the effectiveness of a school-based psycho-educational program. [2015]

11. France pubmed.ncbi.nlm.nih.gov

[Suicide prevention: How to act?] [2022]