Trial Review

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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
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
Secondary ID [1] 285762 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 293645 0
Depression 293646 0
Anxiety 300845 0
Condition category
Condition code
Mental Health 293940 293940 0 0
Depression
Mental Health 293941 293941 0 0
Anxiety

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 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.
Intervention code [1] 290720 0
Behaviour
Intervention code [2] 290721 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] 293717 0
Anxiety and depression are a composite outcome that are measured by mean score on the General Health Questionnaire
Timepoint [1] 293717 0
Pretreatment (week 1), posttreatment (week 7)
Secondary outcome [1] 311653 0
Mean scores on the World Health Organisation Disability Assessment Schedule 2.0
Timepoint [1] 311653 0
Pretreatment (week 1), posttreatment (week 7)
Secondary outcome [2] 311654 0
Mean scores on the Posttraumatic Stress Disorder Checklist
Timepoint [2] 311654 0
Pretreatment (week 1), posttreatment (week 2)
Secondary outcome [3] 329011 0
Personalised outcomes as measured by the Psychological Outcomes Profile (PSYCHLOPS) scale
Timepoint [3] 329011 0
Pretreatment (week 1), posttreatment (week 7), follow up (week 13)
Secondary outcome [4] 329012 0
Health service use as measured by reported access of Nairobi health services
Timepoint [4] 329012 0
Pretreatment (week 1), follow up (week 13)
Secondary outcome [5] 329013 0
Stressful life events as measured by the Life Events Checklist
Timepoint [5] 329013 0
Pretreatment (week 1), follow up (week 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
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/10/2014
Actual
15/04/2015
Date of last participant enrolment
Anticipated
19/12/2014
Actual
20/08/2015
Date of last data collection
Anticipated
Actual
16/01/2016
Sample size
Target
346
Accrual to date
Final
421
Recruitment outside Australia
Country [1] 6501 0
Kenya
State/province [1] 6501 0
Nairobi

Funding & Sponsors
Funding source category [1] 290326 0
Charities/Societies/Foundations
Name [1] 290326 0
Grand Challenges Canada
Country [1] 290326 0
Canada
Primary sponsor type
Charities/Societies/Foundations
Name
World Vision Kenya
Address
P.O Box 50816 - 00200
Nairobi
Country
Kenya
Secondary sponsor category [1] 289046 0
Government body
Name [1] 289046 0
World Health Organisation
Address [1] 289046 0
Avenue Appia 20
1211 Geneva 27
Switzerland
Country [1] 289046 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292035 0
World Health Organisation Ethics Review Committee
Ethics committee address [1] 292035 0
Avenue Appia 20
1211 Geneva 27
Switzerland
Ethics committee country [1] 292035 0
Switzerland
Date submitted for ethics approval [1] 292035 0
21/02/2014
Approval date [1] 292035 0
30/05/2014
Ethics approval number [1] 292035 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53154 0
Prof Richard Bryant
Address 53154 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 53154 0
Australia
Phone 53154 0
61293853640
Fax 53154 0
61293853641
Email 53154 0
r.bryant@unsw.edu.au
Contact person for public queries
Name 53155 0
Ms Dorothy Anjuri
Address 53155 0
World Vision Kenya-Karen Office
P.O. Box 50816-00200
Nairobi
Country 53155 0
Kenya
Phone 53155 0
254 20883652
Fax 53155 0
Email 53155 0
dorothy_anjuri@wvi.org
Contact person for scientific queries
Name 53156 0
Prof Richard Bryant
Address 53156 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 53156 0
Australia
Phone 53156 0
61293853640
Fax 53156 0
61293853641
Email 53156 0
r.bryant@unsw.edu.au

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
EmbaseEffectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial.2017https://dx.doi.org/10.1371/journal.pmed.1002371
N.B. These documents automatically identified may not have been verified by the study sponsor.