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Trial registered on ANZCTR


Registration number
ACTRN12616000032459
Ethics application status
Approved
Date submitted
14/01/2016
Date registered
18/01/2016
Date last updated
12/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low Intensity Intervention to Reduce Depression and Anxiety in Women Exposed to Gender-Based Violence
Scientific title
Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual to Reduce Depression and Anxiety in Women Exposed to Gender-Based Violence
Secondary ID [1] 288313 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 297281 0
Depression 297282 0
Anxiety 297305 0
Condition category
Condition code
Mental Health 297471 297471 0 0
Depression
Mental Health 297472 297472 0 0
Anxiety
Mental Health 297503 297503 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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 60 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. 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. Therapy is provided by local health workers.
Intervention code [1] 293605 0
Behaviour
Intervention code [2] 293606 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 297038 0
Anxiety and depression are a composite outcome that are measured by mean score on the General Health Questionnaire
Timepoint [1] 297038 0
Pretreatment (week 1), posttreatment (week 7), follow up (13)
Secondary outcome [1] 319943 0
Mean scores on the World Health Organisation Disability Assessment Schedule 2.0
Timepoint [1] 319943 0
Pretreatment (week 1), posttreatment (week 7), follow up (13)
Secondary outcome [2] 327922 0
Posttraumatic stress disorder measured by the PTSD Checklist
Timepoint [2] 327922 0
Pretreatment (week 1), posttreatment (week 7), follow up (13)
Secondary outcome [3] 327923 0
Personalised outcomes as measured by the Psychological Outcomes Profile (PSYCHLOPS) scale
Timepoint [3] 327923 0
Pretreatment (week 1), posttreatment (week 7), follow up (13)
Secondary outcome [4] 327924 0
Health service use as measured by reported access of Nairobi health services
Timepoint [4] 327924 0
Pretreatment (week 1), follow up (13)
Secondary outcome [5] 327925 0
Stressful life events as measured by the Life Events Checklist
Timepoint [5] 327925 0
Pretreatment (week 1), follow up (13)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will use hierarchical linear models (HLM) to investigate the relative effects of the treatments. The benefit of this approach is that it presumes intent-to-treat analyses as HLM allows the number of observations to vary between participants and effectively handles missing data. Time (linear and quadratic), treatment condition, and their interaction will be included in the models. Fixed effects parameters will be tested at 95%CI. The Level 1 model will represent within-patient change over time, and the Level 2 model will predict variation in within-patient change over time and encompass between-patient variables (treatment condition, injury characteristics, gender). Primary measures will comprise the GHQ, PCL, and WHODAS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/04/2015
Date of last participant enrolment
Anticipated
1/04/2016
Actual
20/08/2015
Date of last data collection
Anticipated
Actual
6/01/2016
Sample size
Target
490
Accrual to date
Final
522
Recruitment outside Australia
Country [1] 7514 0
Kenya
State/province [1] 7514 0
Nairobi

Funding & Sponsors
Funding source category [1] 292683 0
Charities/Societies/Foundations
Name [1] 292683 0
Grand Challenges Canada
Country [1] 292683 0
Canada
Primary sponsor type
Individual
Name
Richard Bryant
Address
School of Psychology
University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 291403 0
Government body
Name [1] 291403 0
World Health Organisation
Address [1] 291403 0
Avenue Appia 20
1211 Geneva 27
Country [1] 291403 0
Switzerland
Secondary sponsor category [2] 291420 0
Government body
Name [2] 291420 0
World Vision Kenya
Address [2] 291420 0
P.O Box 50816 - 00200
Nairobi
Country [2] 291420 0
Kenya

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294155 0
World Health Organisation Ethics Review Committee
Ethics committee address [1] 294155 0
World Health Organization
Avenue Appia 20
1211 Geneva 27
Ethics committee country [1] 294155 0
Switzerland
Date submitted for ethics approval [1] 294155 0
21/02/2014
Approval date [1] 294155 0
30/05/2014
Ethics approval number [1] 294155 0
292935 0

Summary
Brief summary
The rationale of the pilot study is to evaluate the feasibility of conducting a 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.
Trial website
Trial related presentations / publications
Bryant, R.A., Schafer, A., Dawson, K.S., Anjuri, D., Mulili, C., Ndogoni, L., Koyiet, P., Sijbrandij, M., Ulate, J., Harper, M., Hadzi-Pavlovic, D., van Ommeren, M. (2017). Effectiveness of a Brief Behavioral Intervention on Psychological Distress among Women with a History of Gender-Based Violence in Urban Kenya: A Randomized Clinical Trial. PLOS Medicine, 14, e1002371.
Public notes
Attachments [1] 2770 2770 0 0
/AnzctrAttachments/369917-Kenya RCT.pdf (Publication)

Contacts
Principal investigator
Name 62726 0
Prof Richard Bryant
Address 62726 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 62726 0
Australia
Phone 62726 0
+61 2 9385 3640
Fax 62726 0
+61 2 9385 3641
Email 62726 0
[email protected]
Contact person for public queries
Name 62727 0
Richard Bryant
Address 62727 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 62727 0
Australia
Phone 62727 0
+61 2 9385 3640
Fax 62727 0
+61 2 9385 3641
Email 62727 0
[email protected]
Contact person for scientific queries
Name 62728 0
Richard Bryant
Address 62728 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 62728 0
Australia
Phone 62728 0
+61 2 9385 3640
Fax 62728 0
+61 2 9385 3641
Email 62728 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseProblem Management Plus (PM+) in the treatment of common mental disorders in women affected by gender-based violence and urban adversity in Kenya; study protocol for a randomized controlled trial.2016https://dx.doi.org/10.1186/s13033-016-0075-5
N.B. These documents automatically identified may not have been verified by the study sponsor.