Psychosocial Intervention With Community Worker Support for Survivors of Intimate Partner Violence

NCT03333798 | Unknown

• 1 other identifier: Code No.110674456022
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Female survivors of domestic violence (DV) may exhibit various mental health problems. A variety of psychotherapies are available to improve their mental health, however there is uncertainty on which is the best. In Colombian, national guidelines do not mention which therapy should be used and in practice, psychologists use their preferred approaches. Due to the shortage of psychotherapy appointments, patients wait a long time to initiate treatment and for each subsequent appointment. Furthermore, patients with mental health problems often fail to attend their appointments and often drop-out of their psychotherapy. This study will offer an alternative intervention that is hypothesized to be superior to normal patient care in Colombia. It will be conducted in Cali and Tuluá, which have high levels of DV, internally displaced conflict victims and large socioeconomic inequalities. Psychologists and trained Lay Psychosocial Community Workers (LPCWs) will work together to provide a cognitive-behavioral intervention (CBI) for female survivors of DV, which is a therapy that aims to change the way people think and behave. Each woman will be offered 11 weekly sessions which will be shared between a psychologist and a LPCW. The LPCW will assign tasks to the patients which have been set by the psychologist and will assist participants to attend their appointments. The study´s hypothesis is: 1) A psychologist led CBI with LPCW support is superior to standard psychotherapy care in Colombian health services to improve mental health symptoms of female survivors of DV. Patients will be recruited from health services and will be randomly assigned to either the standard psychotherapy or the CBI with LPCW support (intervention group). In the standard psychotherapy group, patients will receive psychotherapy approximately every four weeks, depending on demand, and will have as many sessions as they require. In the intervention group, patients will be offered eleven weekly CBI sessions. Mental health questionnaires will be used to measure the study participants' mental health symptoms, their functionality, experience of DV and other forms of violence. In the intervention group, these questionnaires will be applied before initiating psychotherapy, two weeks and six months after completing their psychotherapy. Patients in the control group will have questionnaires applied before commencing psychotherapy and fourteen weeks and twenty-two weeks after starting.

Conditions

Intimate Partner Violence; Depression; Anxiety; Post-traumatic Stress Disorder; Activities of Daily Living; Self Esteem

Keywords

Intimate Partner Violence; Domestic Violence; Mental Health; Cognitive- Behavioral Therapy; Community Lay Workers

Outcome Measures

Primary Outcomes (3)

• Score Difference in Symptoms of Anxiety

  Anxiety symptoms will be assess using the Hopkins Symptom Checklist (HSCL-25)

  Measurement at baseline before the intervention, and within the fifteen (15) days after finishing the intervention. In the control group, 12 weeks after the baseline assessment.

• Score Difference in Symptoms of Depression

  Depression symptoms will be assess using the Hopkins Symptom Checklist (HSCL-25)

  Measurement at baseline before the intervention, and within the fifteen (15) days after finishing the intervention. In the control group, 12 weeks after the baseline assessment.

• Score Difference in Symptoms of Post-Traumatic Stress Disorders

  Symptoms of trauma (PTSS) will be assess using the Harvard Trauma Questionnaire (HTQ).

  Measurement at baseline before the intervention, and within the fifteen (15) days after finishing the intervention. In the control group, 12 weeks after the baseline assessment.

Secondary Outcomes (3)

• Score Difference in Disability

  Measurement at baseline before the intervention, and within the fifteen (15) days after finishing the intervention. In the control group, 12 weeks after the baseline assessment.

• Score Difference in Self-Esteem.

  Measurement at baseline before the intervention, and within the fifteen (15) days after finishing the intervention. In the control group, 12 weeks after the baseline assessment.

• Score Difference in Emotional Dependence Scales.

  Measurement at baseline before the intervention, and within the fifteen (15) days after finishing the intervention. In the control group, 12 weeks after the baseline assessment.

Study Arms (2)

Cognitive-Behavioral Intervention

EXPERIMENTAL

Cognitive-Behavioral Intervention with community worker support.

Behavioral: Cognitive-Behavioral Intervention

Standard psychosocial care

ACTIVE COMPARATOR

Standard psychosocial care delivered by health services.

Behavioral: Standard psychosocial care

Interventions

Cognitive-Behavioral Intervention BEHAVIORAL

A Cognitive-Behavioral intervention will be delivered by psychologists with LPCWs support. LPCWs who will be under the supervision and guidance of psychologists. Volunteers will receive 11 weekly sessions of which six will be provided by psychologists and five by LPCWs. The Cognitive-Behavioral component will be delivered through a set modules that will cover the following components: * The Cognitive-Behavioral model * Tackling traumatic events * Cognitive reprocessing * Relaxation techniques * Prevention of revictimization * Behavioral reactivation for the start of a new life The intervention will be given within the health system and volunteers will be seen if necessary by an interdisciplinary team including social workers, general physicians and psychiatrists.

Cognitive-Behavioral Intervention

Standard psychosocial care BEHAVIORAL

The active control group will receive standard psychosocial care for intimate partner violence, provided by the participating health centers. Standard care is delivered by psychologists, social workers, general physicians and psychiatrists. Additionally, patients receive extramural support which includes telephone calls or domiciliary visits from a variety of health professionals (doctors, nurses, social workers and nursing assistants). Psychology consultations typically occur every four weeks in each health center. Psychologists use a variety of approaches according to their personal preferences, including humanist, psychoanalytic, psychodynamic and cognitive-behavioral approaches. At the end of the intervention psychologists will be asked which approach or approaches they used.

Standard psychosocial care

Eligibility Criteria

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

You may qualify if:

• Female survivors of IPV
• Inhabitants of Cali or Tuluá, Valle del Cauca
• years old or older

You may not qualify if:

• Severe mental illness that requires specialized treatment (determined by a psychiatrist or psychiatry resident)
• Terminally ill
• Decompensated chronic diseases
• Hypothyroidism (not controlled by medication)
• Neurosyphilis
• Under psychiatric medication
• Sexual abuse

Sponsors & Collaborators

• Universidad del Valle, Colombia: lead
• Universidad Unidad Central del Valle (UCEVA): collaborator
• Red de Salud de Ladera E.S.E: collaborator
• Hospital Rubén Cruz Vélez E.S.E: collaborator
• Heartland Alliance: collaborator

Related Publications (2)

• Murray LK, Dorsey S, Bolton P, Jordans MJ, Rahman A, Bass J, Verdeli H. Building capacity in mental health interventions in low resource countries: an apprenticeship model for training local providers. Int J Ment Health Syst. 2011 Nov 18;5(1):30. doi: 10.1186/1752-4458-5-30.

  PMID: 22099582 BACKGROUND

• Johnson DM, Zlotnick C, Perez S. Cognitive behavioral treatment of PTSD in residents of battered women's shelters: results of a randomized clinical trial. J Consult Clin Psychol. 2011 Aug;79(4):542-551. doi: 10.1037/a0023822.

  PMID: 21787052 BACKGROUND

Related Links

• Evaluation of Two Community-based Mental Health Interventions for Violence-Displaced Afro-Descendants in Colombia. (ACOPLE)

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Personal Satisfaction

Study Officials

• Carlos A Fandiño, MD, PhD

  Universidad del Valle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos A Fandiño, MD, PhD

CONTACT

(+57-2)5577206; carlos.fandino@correounivalle.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 7, 2017
• Study Start: November 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2019
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share