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Trial record 9 of 10 for:    Recruiting, Not yet recruiting, Available Studies | "Domestic Violence"

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

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ClinicalTrials.gov Identifier: NCT03333798
Recruitment Status : Not yet recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborators:
Universidad Unidad Central del Valle (UCEVA)
Red de Salud de Ladera E.S.E
Hospital Rubén Cruz Vélez E.S.E
Heartland Alliance
Information provided by (Responsible Party):
Universidad del Valle, Colombia

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.


Condition or disease Intervention/treatment Phase
Intimate Partner Violence Depression Anxiety Post-traumatic Stress Disorder Activities of Daily Living Self Esteem Behavioral: Cognitive-Behavioral Intervention Behavioral: Standard psychosocial care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Cognitive-Behavioral Intervention With Community Worker Support for Survivors of Intimate Partner Violence in Cali and Tuluá, Colombia.
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: Cognitive-Behavioral Intervention
Cognitive-Behavioral Intervention with community worker support.
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.

Active Comparator: Standard psychosocial care
Standard psychosocial care delivered by health services.
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.





Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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 Outcome Measures :
  1. Score Difference in Disability [ 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. ]
    Disability will be assess using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0).

  2. Score Difference in Self-Esteem. [ 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. ]
    Self-esteem will be assess using the Rosenberg's Self-Esteem Scale. Each question has response that gives a score between 1-4. A mean score of responses will be calculated to give the final score.

  3. Score Difference in Emotional Dependence Scales. [ 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. ]
    Emotional dependency will be asses using the Emotional Dependence Scale (Cuestionario de Dependencia Emocional). Each question has response that gives a score between 1-6. A mean score of responses will be calculated to give the final score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333798


Contacts
Contact: Carlos A Fandiño, MD, PhD (+57-2)5577206 ext 108 carlos.fandino@correounivalle.edu.co

Sponsors and Collaborators
Universidad del Valle, Colombia
Universidad Unidad Central del Valle (UCEVA)
Red de Salud de Ladera E.S.E
Hospital Rubén Cruz Vélez E.S.E
Heartland Alliance
Investigators
Principal Investigator: Carlos A Fandiño, MD, PhD Universidad del Valle

Additional Information:
Publications:
Responsible Party: Universidad del Valle, Colombia
ClinicalTrials.gov Identifier: NCT03333798     History of Changes
Other Study ID Numbers: Code No.110674456022
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planned.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad del Valle, Colombia:
Intimate Partner Violence
Domestic Violence
Mental Health
Cognitive- Behavioral Therapy
Community Lay Workers

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders