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

NCT03333798 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-11-07

No results posted yet for this study

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

Interventions

BEHAVIORAL

Cognitive-Behavioral Intervention

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.

BEHAVIORAL

Standard psychosocial care

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.

Sponsors & Collaborators

  • Universidad Unidad Central del Valle (UCEVA)

    collaborator UNKNOWN
  • Red de Salud de Ladera E.S.E

    collaborator UNKNOWN
  • Hospital Rubén Cruz Vélez E.S.E

    collaborator UNKNOWN
  • Heartland Alliance

    collaborator OTHER
  • Universidad del Valle, Colombia

    lead OTHER

Principal Investigators

  • Carlos A Fandiño, MD, PhD · Universidad del Valle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2018-06-30
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333798 on ClinicalTrials.gov