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Recruiting NCT00601939

Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships

No phase Interventional Battered Women Suicide, Attempted

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychoeducational intervention (PEI), Enhanced treatment as usual (ETAU).
Who it may be relevant to
Registry conditions: Battered Women, Suicide, Attempted. Basic parameters: 18 years — 64 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Group Interventions for Abused, Suicidal Black Women

Overview

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

Detailed description

Most suicide attempts are a sign of great distress, often originating from depression; physical and sexual abuse; substance abuse; or family history of suicide, violence, or mental disorder. Risk factors for suicidal behavior are diverse, differing with gender, age, and ethnicity. Since the mid-1980s, the number of reported suicides and suicidal thoughts among young black individuals has increased alarmingly. The higher rates may be caused by high stress living situations attributed to poverty, abuse, discrimination, racism, and difficult family life. Therefore, cultural environments, social situations, and intrapersonal influences are important considerations in developing an effective therapy to prevent suicide. This study will evaluate the effect of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.

The participants in this single-blind study will be randomly placed in one of two treatment groups. One group will receive psychoeducational intervention (PEI) and the other will receive enhanced treatment as usual (ETAU). After screening, eligible participants will complete a 2-hour survey about life events, concerns, and feelings with a research team member. One week later, participants will complete a second 1-hour survey. Participants will then be randomly placed in the treatment groups. Participants in both groups will receive treatment at Grady Health System, but those in the PEI group will also attend 10 weekly, 90-minute group sessions. The PEI empowerment group sessions will incorporate cultural, social, and intrapersonal elements. The ETAU group will be given mental health treatment as usual plus an adherence enhancement protocol. Follow-up surveys will occur at Week 10 (after treatment completion) and at Months 6 and 12 post-treatment.

Interventions

  • Behavioral Psychoeducational intervention (PEI)
    PEI consists of 10 culturally competent group empowerment psychoeducational sessions. The sessions are directed by a treatment manual and are co-led by two therapists. The sessions are guided by the theory of triadic influence (TTI) model, which incorporates cultural-environmental influences, social-situational influences, and intrapersonal influences into treatment.
  • Behavioral Enhanced treatment as usual (ETAU)
    ETAU contains an adherence protocol plus access to weekly support group and a resource room.

Primary outcome measures

  • Change in Beck Scale for Suicide Ideation Score [Time frame: Baseline, Week 10, Post-treatment Months 6 and 12]
  • Change in Suicide Attempt Index [Time frame: Baseline, Week 10, Post-treatment Months 6 and 12]
  • Change in Index of Spouse Abuse Score [Time frame: Baseline, Week 10, Post-treatment Months 6 and 12]
Secondary outcome measures (3)
  • Change in Beck Depression Inventory- II [Time frame: Baseline, Week 10, Post-treatment Months 6 and 12]
  • Change in Beck Hopelessness Scale [Time frame: Baseline, Week 10, Post-treatment Months 6 and 12]
  • Change in Self-Efficacy Scale for Battered Women [Time frame: Baseline, Week 10, Post-treatment Months 6 and 12]

Eligibility criteria

Inclusion criteria

  • Identifies as an African-American female
  • Abusive relationship within the 12 months prior to study entry
  • Suicide attempt within the 12 months prior to study entry
  • Seeks services at Grady Health System

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Grady Hospital — Atlanta

Publications

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2. PMID 33884617

Identifiers

NCT: NCT00601939 · IRB00045774 · R01MH078002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗