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Trial registered on ANZCTR
Registration number
ACTRN12614001291673
Ethics application status
Approved
Date submitted
1/12/2014
Date registered
10/12/2014
Date last updated
7/11/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Low Intensity Intervention to Reduce Depression and Anxiety in Women Exposed to Gender-Based Violence
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Scientific title
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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Secondary ID [1]
285762
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder
293645
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Depression
293646
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Anxiety
300845
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Condition category
Condition code
Mental Health
293940
293940
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0
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Depression
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Mental Health
293941
293941
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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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Intervention code [1]
290720
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Behaviour
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Intervention code [2]
290721
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Treatment: Other
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Comparator / control treatment
Enhanced Treatment as Usual comprises normal treatment provided by local primary care providers (usually nurses) who have received training in supportive counseling and psychological first aid. Treatment as Usual involves non-directive counselling about daily problems reported by participants, as well as provision of basic education about common psychological problems. Attendance at sessions will be monitored via session attendance records. Adherence to strategies will be monitored by checklists of strategies employed. 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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Anxiety and depression are a composite outcome that are measured by mean score on the General Health Questionnaire
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Assessment method [1]
293717
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Timepoint [1]
293717
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Pretreatment (week 1), posttreatment (week 7)
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Secondary outcome [1]
311653
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Mean scores on the World Health Organisation Disability Assessment Schedule 2.0
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Assessment method [1]
311653
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Timepoint [1]
311653
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Pretreatment (week 1), posttreatment (week 7)
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Secondary outcome [2]
311654
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Mean scores on the Posttraumatic Stress Disorder Checklist
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Assessment method [2]
311654
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Timepoint [2]
311654
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Pretreatment (week 1), posttreatment (week 2)
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Secondary outcome [3]
329011
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Personalised outcomes as measured by the Psychological Outcomes Profile (PSYCHLOPS) scale
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Assessment method [3]
329011
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Timepoint [3]
329011
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Pretreatment (week 1), posttreatment (week 7), follow up (week 13)
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Secondary outcome [4]
329012
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Health service use as measured by reported access of Nairobi health services
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Assessment method [4]
329012
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Timepoint [4]
329012
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Pretreatment (week 1), follow up (week 13)
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Secondary outcome [5]
329013
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Stressful life events as measured by the Life Events Checklist
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Assessment method [5]
329013
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Timepoint [5]
329013
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Pretreatment (week 1), follow up (week 13)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be adult females who will be included through community screening by independent assessors in the catchment area of volunteer Community Health Workers. Participants will be enrolled when indicating moderate distress & impaired functioning. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual unit.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized by an independent research assistant, not involved in the assessments. There is no stratification in this pilot trial. Randomisation will occur by a randomization table created by a computerized sequence.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size was calculated on prediction of small effect size (d = 0.4) on the GHQ-12. Power calculations indicated a minimum sample of 133 per group (power = 0.95, alpha = 0.05. two-sided). On basis of 30% attrition, it estimated that 346 participants (173 per group) is needed.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
22/10/2014
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Actual
15/04/2015
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Date of last participant enrolment
Anticipated
19/12/2014
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Actual
20/08/2015
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Date of last data collection
Anticipated
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Actual
16/01/2016
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Sample size
Target
346
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Accrual to date
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Final
421
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Recruitment outside Australia
Country [1]
6501
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Kenya
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State/province [1]
6501
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Nairobi
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Funding & Sponsors
Funding source category [1]
290326
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Charities/Societies/Foundations
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Name [1]
290326
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Grand Challenges Canada
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Address [1]
290326
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MaRS Centre
South Tower
101 College Street
Suite 406
Toronto, Ontario, M5G 1L7
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Country [1]
290326
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Canada
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Primary sponsor type
Charities/Societies/Foundations
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Name
World Vision Kenya
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Address
P.O Box 50816 - 00200
Nairobi
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Country
Kenya
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Secondary sponsor category [1]
289046
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Government body
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Name [1]
289046
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World Health Organisation
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Address [1]
289046
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Avenue Appia 20
1211 Geneva 27
Switzerland
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Country [1]
289046
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Switzerland
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
292035
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World Health Organisation Ethics Review Committee
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Ethics committee address [1]
292035
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Avenue Appia 20 1211 Geneva 27 Switzerland
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Ethics committee country [1]
292035
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Switzerland
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Date submitted for ethics approval [1]
292035
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21/02/2014
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Approval date [1]
292035
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30/05/2014
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Ethics approval number [1]
292035
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Summary
Brief summary
The rationale is to conducting a pilot and definitive RCT of a low intensity intervention to reduce mental health problems in people in low-resource settings. This study compares the relative efficacy of (a) Problem Management Plus will lead to greater symptom reduction than (b) Enhanced Treatment as Usual.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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
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Country
53154
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Australia
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Phone
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61293853640
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Fax
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61293853641
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Email
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r.bryant@unsw.edu.au
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Contact person for public queries
Name
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Dorothy Anjuri
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Address
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World Vision Kenya-Karen Office
P.O. Box 50816-00200
Nairobi
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Country
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Kenya
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Phone
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254 20883652
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Fax
53155
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Email
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dorothy_anjuri@wvi.org
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Contact person for scientific queries
Name
53156
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Richard Bryant
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Address
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School of Psychology
University of New South Wales
Sydney NSW 2052
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Country
53156
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Australia
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Phone
53156
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61293853640
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Fax
53156
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61293853641
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Email
53156
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r.bryant@unsw.edu.au
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial.
2017
https://dx.doi.org/10.1371/journal.pmed.1002371
N.B. These documents automatically identified may not have been verified by the study sponsor.
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