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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614001291673 |
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Date of registration:
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10/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Low Intensity Intervention to Reduce Depression and Anxiety in Women Exposed to Gender-Based Violence
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Scientific title:
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Exploratory Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual to Reduce Depression and Anxiety in Women Exposed to Gender-Based Violence |
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Date of first enrolment:
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15/04/2015 |
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Target sample size:
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346 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12614001291673.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Prof Richard Bryant
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Address:
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School of Psychology
University of New South Wales
Sydney NSW 2052
Australia |
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Telephone:
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61293853640 |
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Email:
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r.bryant@unsw.edu.au |
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Affiliation:
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Name:
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Ms Dorothy Anjuri
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Address:
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World Vision Kenya-Karen Office
P.O. Box 50816-00200
Nairobi
Kenya |
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Telephone:
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254 20883652 |
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Email:
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dorothy_anjuri@wvi.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Women exposed to gender-based violence and indicate significant distress as reflected in scores on GHQ > 2 and impaired functioning reflected in scores on WHODAS > 16
Exclusion criteria: (a) Imminent suicidal intent, (b) severe mental disorder, (c) severe cognitive impairment, (d) acute protection risks, (e) exposure to trauma in last month, (f) male gender, (g) acute protection risks
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Mental Health - Depression
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Mental Health - Anxiety
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Posttraumatic stress disorder;Depression;Anxiety;
Posttraumatic stress disorder
Depression
Anxiety
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Intervention(s)
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There are two arms to this trial. Arm 1: Problem Management Plus. Arm 2: Enhanced Treatment as Usual. Therapy is administered once-weekly over 5 weeks on an individual 90 minute basis. Problem Management Plus includes skills in identifying emotional and practical problems that can be managed and strategies to reduce and cope with these problems. The duration of the study for any participant will conclude after immediate post-trial follow-up assessment, resulting in participation duration of 1.5 months. Therapy is provided by local health workers.
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Primary Outcome(s)
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Anxiety and depression are a composite outcome that are measured by mean score on the General Health Questionnaire[Pretreatment (week 1), posttreatment (week 7)]
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Secondary Outcome(s)
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Mean scores on the World Health Organisation Disability Assessment Schedule 2.0[Pretreatment (week 1), posttreatment (week 7)]
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Health service use as measured by reported access of Nairobi health services [Pretreatment (week 1), follow up (week 13) ]
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Stressful life events as measured by the Life Events Checklist [Pretreatment (week 1), follow up (week 13) ]
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Mean scores on the Posttraumatic Stress Disorder Checklist[Pretreatment (week 1), posttreatment (week 2)]
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Personalised outcomes as measured by the Psychological Outcomes Profile (PSYCHLOPS) scale [Pretreatment (week 1), posttreatment (week 7), follow up (week 13) ]
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Source(s) of Monetary Support
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Grand Challenges Canada
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Ethics review
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Status: Approved
Approval date:
Contact:
World Health Organisation Ethics Review Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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