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Clinical Trials/NCT03333798
NCT03333798UnknownNot Applicable

A Cognitive-Behavioral Intervention With Community Worker Support for Survivors of Intimate Partner Violence in Cali and Tuluá, Colombia.

Universidad del Valle, Colombia0 sites200 target enrollmentStarted: November 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
200
Primary Endpoint
Score Difference in Symptoms of Anxiety

Study Overview

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.

Detailed Description

Intimate partner violence (IPV) is a complex problem because it is associated with factors at a variety of levels which include the individual, conjugal, societal, cultural, and institutional, which can all also act as barriers to accessing mental health services. Survivors of IPV are vulnerable to an array of mental health illnesses which include post-traumatic stress disorder (PTSD), depression, anxiety, emotional dependency and low self-esteem. A variety of psychotherapies are available to improve mental illnesses, however there is uncertainty on which is the superior approach. In Colombia there are no national guidelines outlining which therapy should be used, rather, psychologists use their preferred approach or approaches which may include humanistic or psychoanalytical methods. Furthermore, patients with mental health problems face a large waiting list for initial and follow-up psychotherapy appointments, often fail to attend and do not complete their treatment. This study will be conducted in two cities, Cali and Tuluá, in the state Valle del Cauca that have high levels of IPV, internally displaced conflict victims and large socioeconomic inequalities.

The study´s hypothesis is that a psychologist led cognitive-behavioral intervention with Lay Psychosocial Community Worker (LPCW) support is superior to treatment as usual to reduce mental illness symptoms. The study's objective is to improve mental illness symptoms of female survivors of IPV through the program IPCCOS, a Cognitive-Behavioral Intervention with Community Worker Support for Survivors of Intimate Partner Violence (IPCCOS is the abbreviation for its name in Spanish: Intervención Psicoterapéutico Cognitivo-Conductual con Apoyo Comunitario para Sobrevivientes de Violencia de Pareja). IPCCOS was developed by the CISALVA Institute at the Universidad del Valle (Cali), the Universidad Central del Valle del Cauca UCEVA (Tuluá), with assistance from Heartland Alliance International (HAI) to provide and test an alternative intervention for female survivors of IPV. Each patient will be offered 11 weekly psychotherapy sessions which will be divided between a psychologist and a LPCW. The LPCWs in the study will come from community women groups who are already working in women´s rights and have exposure to violence against women and the relevant medico-legal systems. They will receive up to a week of intensive training from study psychologists and a psychologist from HAI who is trained in cognitive-behavioral therapy (CBT) and has experience training and supervising LPCWs in other mental health studies in Colombia. Approximately six weeks after initiating the intervention, LPCWs will receive a further day of training. LPCWs will assign tasks to patients which have been set by the psychologist and will assist them to overcome any barriers to attend their appointments. They will be closely supervised by the psychologist once per week to discuss their patients.

A randomized control trial study design will be used to compare and evaluate the two groups. Patients will be recruited from health services if they are found to have experimented IPV in the last year and will be randomly assigned by block randomization to either treatment as usual or the IPCCOS (intervention group). Patients will be invited to participate in the study from three sources:

  • General physician outpatient appointments.
  • Hospital data bases. Hospital records will be searched to detect patients that have experienced IPV and that have not commenced psychotherapy. This will be performed retrospectively to search for patients that were given this diagnosis of IPV between January 2017 and September 2017. They will be contacted via phone, given a brief description of the study and if they are interested in participating, they will be invited to meet a health professional who will give a more detailed description of the study and take informed consent.
  • Patients that are detected to have experienced IPV in the Emergency Department will be told about the study. They will only be asked to decide on their participation one week after they have been discharged.

In the treatment as usual group, patients normally receive psychotherapy every four weeks, depending on demand. There is no pre-established number of sessions as this depends on the clinical condition and the patient´s adherence.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Cognitive-Behavioral Intervention

Experimental

Cognitive-Behavioral Intervention with community worker support.

Intervention: Cognitive-Behavioral Intervention (Behavioral)

Standard psychosocial care

Active Comparator

Standard psychosocial care delivered by health services.

Intervention: Standard psychosocial care (Behavioral)

Outcomes

Primary Outcomes

Score Difference in Symptoms of Anxiety

Time Frame: 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.

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

Score Difference in Symptoms of Depression

Time Frame: 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.

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

Score Difference in Symptoms of Post-Traumatic Stress Disorders

Time Frame: 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.

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

Secondary Outcomes

  • 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.)
  • 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.)

Investigators

Sponsor
Universidad del Valle, Colombia
Sponsor Class
Other
Responsible Party
Sponsor

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