NCT06768502

Brief Summary

Abstract Background: There is a little known about the effectiveness of Community-Based Approach (CBA) on reduction of intimate partner violence (IPV) exposure, anxiety, depression and PTSD symptoms as outcomes in collectivist and post-genocide societies like Rwanda. This study, therefore, aimed at assessing the effectiveness of Community-Based Approach (CBA) for IPV victimization and perpetration as well as it's associated mental health outcomes in Rwanda. Methods: This is a Randomized Controlled Trial (RCT) study which will be conducted using a sample of 31 couples (MA =36.9, SD=9.9), with 16 couples assigned in treatment group and 15 assigned in control group. Data has to be collected using the Hurt, Insult, Threaten and Screaming (HITS-7) to assess IPV exposure; the Hopkins Symptom Checklist for anxiety and depression (HSCL-25); and the PTSD checklist for DSM-5 (PCL-5). Data will be analyzed using Pearson correlation and mixed ANOVAs to evaluate the effect of CBA over IPV occurrence and mental health outcomes. Key words: IPV, community support, emotions management, anxiety, depression, PTSD, Rwanda

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

14 days

First QC Date

August 18, 2024

Last Update Submit

January 6, 2025

Conditions

Keywords

IPVcommunity supportemotions managementanxietydepressionPTSDRwanda

Outcome Measures

Primary Outcomes (4)

  • Reduced intimate Partner Violence scores in treatment group as compared to control groups

    Analysis of effectiveness community based approach in reducing the IPV scores. IPV scores were assessed using The Hurt, Insult, Threaten, and Scream scale which has 7 items with a likert scaled response. All items were scored as: 0=never, 1=rarely, 2=sometimes, 3=fairly often, and 4=frequently. The total scores ranged from Score 0 to 24, where higher scores mean worse outcome.

    through study completion, an average of 10 months

  • Reduced Anxiety scores in treatment group as compared to control groups

    Analysis of effectiveness community based approach in reducing the anxiety scores. The Hopkins Symptom Check List-25 scale was used to evaluate depression scores. Its first 10 items assess anxiety symptoms. The scale for each item includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). The total scores range from 1 to 40, where higher scores mean worse outcome.

    through study completion, an average of 10 months

  • Reduced depression scores in treatment group as compared to control groups

    Analysis of effectiveness community based approach in reducing the depression scores. Its last 15 items assess depression. The scale for each item includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively).The total scores range from 1 to 60,where higher scores mean worse outcome.

    through study completion, an average of 10 months

  • Reduced post-traumatic stress disorder scores in treatment as compared to control groups

    Analysis of effectiveness community based approach in reducing post-traumatic stress disorder scores.The PTSD Checklist for DSM-5 (PCL-5) is a 20 items self-reported instrument that was used to evaluate the 20 DSM-5 symptoms of post-traumatic stress disorder (Weathers et al., 2013). All items were scored on the Likert scale: 0=Not at all, 1=A little bit, 2=moderately, 3=Quite a bit and 4=extremely. The total score ranged from 0 to 80, where higher scores mean worse outcome.

    through study completion, an average of 10 months

Study Arms (2)

treatment group

EXPERIMENTAL

This arm includes couples selected from a list provided by authorities at the sector level, identifying households with a history of family violence. These couples will receive the Community-Based Approach (CBA) intervention and will be assigned to the treatment group.

Other: Community Based Approach (CBA)

control group

NO INTERVENTION

This arm includes couples selected from a list provided by authorities at the sector level, identifying households with a history of family violence. These couples will not receive the Community-Based Approach (CBA) intervention and will be assigned to the control group.

Interventions

The community-based approach on IPV and sexual violence is conceived as a dynamic process where community members willing to recover from life wounds induced by IPV and sexual violence agree to share their lived experiences in order to work on them accordingly and to support each other in this healing journey.

treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to participate
  • Attended all session

You may not qualify if:

  • Lost the follow up
  • Declined the participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Mental Health

Kigali, Western, KG 11 Ave, 47, Rwanda

Location

Related Publications (30)

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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
  • Chatterji, S., & Heise, L. (2021). Examining the bi-directional relationship between intimate partner violence and depression: Findings from a longitudinal study among women and men in rural Rwanda. SSM - Mental Health, 1, 10. https://doi.org/10.1016/j.ssmmh.2021.100038

    BACKGROUND
  • Chilanga E, Collin-Vezina D, Khan MN, Riley L. Prevalence and determinants of intimate partner violence against mothers of children under-five years in Central Malawi. BMC Public Health. 2020 Dec 2;20(1):1848. doi: 10.1186/s12889-020-09910-z.

    PMID: 33267864BACKGROUND
  • Clear, T. R. (2007). Imprisoning Communities: How Mass Incarceration Makes Disadvantaged Neighborhoods Worse. https://doi.org/10.1093/acprof:oso/9780195305791.001.0001

    BACKGROUND
  • Davoren, M., Kallis, C., González, R. A., Freestone, M., & Coid, J. W. (2017). Anxiety disorders and intimate partner violence: can the association be explained by coexisting conditions or borderline personality traits? The Journal of Forensic Psychiatry & Psychology. https://doi.org/10.1080/14789949.2016.1172659

    BACKGROUND
  • DeJonghe ES, Bogat GA, Levendosky AA, von Eye A. Women survivors of intimate partner violence and post-traumatic stress disorder: prediction and prevention. J Postgrad Med. 2008 Oct-Dec;54(4):294-300. doi: 10.4103/0022-3859.41435.

    PMID: 18953149BACKGROUND
  • Dunkle K, Stern E, Chatterji S, Heise L. Effective prevention of intimate partner violence through couples training: a randomised controlled trial of Indashyikirwa in Rwanda. BMJ Glob Health. 2020 Dec;5(12):e002439. doi: 10.1136/bmjgh-2020-002439.

    PMID: 33355268BACKGROUND
  • Dunkle, K., Stern, E., Chatterji, S., Heise, L., Mclean, L., & Chatterji, S. (2019). Indashyikirwa programme to reduce intimate partner violence in Rwanda: Report of findings from a cluster randomized control trial. August, 1-56. https://www.whatworks.co.za/documents/publications/352-indash-evidence-brief-aug-2019/file

    BACKGROUND
  • Esie P, Osypuk TL, Schuler SR, Bates LM. Intimate partner violence and depression in rural Bangladesh: Accounting for violence severity in a high prevalence setting. SSM Popul Health. 2019 Jan 28;7:100368. doi: 10.1016/j.ssmph.2019.100368. eCollection 2019 Apr.

    PMID: 30766911BACKGROUND
  • Jabbi A, Ndow B, Senghore T, Sanyang E, Kargbo JC, Bass P. Prevalence and factors associated with intimate partner violence against women in The Gambia: a population-based analysis. Women Health. 2020 Sep;60(8):912-928. doi: 10.1080/03630242.2020.1767264. Epub 2020 May 18.

    PMID: 32419660BACKGROUND
  • Kabakambira JD, Uwera G, Hategeka M, Kayitesi ML, Malu CKK, Hategeka C. Burden of post-traumatic stress disorder acute exacerbations during the commemorations of the genocide against Tutsis in Rwanda: a cross-sectional study. Pan Afr Med J. 2018 Jul 17;30:216. doi: 10.11604/pamj.2018.30.216.15663. eCollection 2018.

    PMID: 30574235BACKGROUND
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    PMID: 28193198BACKGROUND
  • King, R. U. (2019). The true healing is healing together: Healing and rebuilding social relations in postgenocide Rwanda. Peace and Conflict. Journal of Peace Psychology, 25(1), 49-60. https://doi.org/10.1037/pac0000357

    BACKGROUND
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    PMID: 28424072BACKGROUND
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    PMID: 32658827BACKGROUND
  • Mutuyimana, C., Sezibera, V., & Cassady, C. (2022). Determinants of Intergenerational Trauma Transmission: A Case of the Survivors of the 1994 Genocide Against Tutsi in Rwanda. In F. M. Ssewamala, O. Sensoy Bahar, & M. M. McKay, Child Behavioral Health in Sub-Saharan Africa Towards Evidence Generation and Policy Development (Vols. 213-233). Springer Nature Switzerland AG, Switzerland.

    BACKGROUND
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    PMID: 19139449BACKGROUND
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    BACKGROUND
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    PMID: 26511348BACKGROUND
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    PMID: 25406929BACKGROUND
  • Vindbjerg E, Carlsson J, Mortensen EL, Makransky G, Nielsen T. A Rasch-based validity study of the Harvard Trauma Questionnaire. J Affect Disord. 2020 Dec 1;277:697-705. doi: 10.1016/j.jad.2020.08.071. Epub 2020 Sep 1.

    PMID: 32911220BACKGROUND
  • Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & & Schnurr, P. P. (2013). The PTSD Checklist for DSM-5 (PCL-5).Scale available from the National Center for PTSD at. www.ptsd.va.gov.

    BACKGROUND
  • Sardinha L, Maheu-Giroux M, Stockl H, Meyer SR, Garcia-Moreno C. Global, regional, and national prevalence estimates of physical or sexual, or both, intimate partner violence against women in 2018. Lancet. 2022 Feb 26;399(10327):803-813. doi: 10.1016/S0140-6736(21)02664-7. Epub 2022 Feb 16.

    PMID: 35182472BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Vincent Sezibera, Professor

    University of Rwanda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * Arm 1 (Intervention Group): Describe the intervention that this group will receive intervention * Arm 2 (Control Group): Describe what the control group will receive no intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 18, 2024

First Posted

January 10, 2025

Study Start

February 18, 2020

Primary Completion

March 3, 2020

Study Completion

December 11, 2020

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations