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Trial registered on ANZCTR


Registration number
ACTRN12615000210572
Ethics application status
Approved
Date submitted
26/02/2015
Date registered
5/03/2015
Date last updated
19/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Low Intensity Intervention to Reduce Depression and Anxiety in women Exposed to Adversity
Scientific title
Exploratory Cluster Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual to Reduce Depression and Anxiety in women Exposed to Adversity
Secondary ID [1] 286279 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 294346 0
Post Traumatic Stress Disorder 294347 0
Anxiety 294348 0
Condition category
Condition code
Mental Health 294666 294666 0 0
Depression
Mental Health 294667 294667 0 0
Anxiety
Mental Health 294668 294668 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: Group Problem Management Plus. Arm 2: Enhanced Treatment as Usual. Therapy is administered onceweekly over 5 weeks in a group format over 3 hours. 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 lay health counselors along with community health workers.
Intervention code [1] 291301 0
Behaviour
Intervention code [2] 291302 0
Treatment: Other
Comparator / control treatment
Enhanced Treatment as Usual comprises normal routine visits conducted by the local community health workers (LHWs). Care is enhanced in 2 ways: (a) LHWs in the EUC arm will receive training in making referrals to their primary care physicians for treatment; and (b) These primary care physicians will receive the standard training in treatment of common mental disorders routinely taught by our partner, the WHO Collaborating Center in Rawalpindi, Pakistan. If, during this treatment or during the study’s assessments participants in EUC arm show severe psychiatric disorders (eg psychosis) or problems (e.g., suicidality) that require immediate specialist treatment and follow-up, they will be referred to specialist staff (e.g., psychiatrist) within the District Headquarter Hospital. The duration of the study for any participant will conclude after post-trial follow-up assessment, resulting in participation duration of 1.5 months.
Control group
Active

Outcomes
Primary outcome [1] 294420 0
Anxiety as measured by mean scores on the Hospital Anxiety and Depression Scale
Timepoint [1] 294420 0
Pretreatment (week 1), posttreatment (week 7)
Primary outcome [2] 294421 0
Depression as measured by mean scores on the Hospital Anxiety and Depression Scale
Timepoint [2] 294421 0
Pretreatment (week 1), posttreatment (week 7)
Secondary outcome [1] 313274 0
Functioning as measured by means scores on the World Health Organisation Disability Assessment Scale (WHODAS)
Timepoint [1] 313274 0
Pretreatment (week 1), posttreatment (week 7)
Secondary outcome [2] 313275 0
Posttraumatic stress disorder as measured by means scores on the Posttraumatic Stress Disorder Checklist
Timepoint [2] 313275 0
Pretreatment (week 1), posttreatment (week 7)

Eligibility
Key inclusion criteria
GHQ >2 and 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.

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 women above 18 years referred by their community health workers and indicating moderate distress & impaired functioning. As a cluster randomized control trial the unit of randomization is LHWs, who each have one catchment area of approximately 150 homes or a population of 1,000 persons. All LHWs in Qambar (20) are eligible for randomization, which will be done by a researcher at the independent trial center at the Human Development Research Foundation who is not involved in intervention delivery, clinical supervision, independent assessment or other aspects of the day-to-day running of the study. Within the Qambar Union Council an even number of LHWs will be randomized to the intervention and EUC arm, using a 1:1 allocation ratio. This design is necessary to reduce the chance of contamination that would be present in an individual RCT design as it is possible more than one woman from each household will meet the inclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a computer generated system and will be conducted using 1:1 allocation ratio.
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
The data, as collected by independent assessors will be safely stored at
the site office. Access to this office will be controlled by the site PI. The
data will be entered into a data-analytic computer program (e.g., SPSS),
without the identifying key. Data will only be available to the members of
the project group. No attributable data will be used in publications. Both
intention-to-treat analysis and completers’ analyses will be carried out.
To measure comparisons at baseline between the two treatment groups
t-tests will be conducted for continuous variables and chi-squared test
for categorical ones. Repeated measurement analysis will be carried out
to assess differential change over time in mean HADS scores between
groups. We will add the following covariates at baseline to examine
subgroup effects: education, and severity of symptoms. All analyses will
be carried out in SPSS, with p-levels of <.05 indicating statistical
significance.
Since this is an exploratory cluster RCT with 120 participants (60 participants per arm) that does not aim to detect statistically significant differences in effectiveness, no power calculations have been (or should be) carried out.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/03/2015
Actual
23/03/2015
Date of last participant enrolment
Anticipated
2/05/2015
Actual
19/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
119
Recruitment outside Australia
Country [1] 6703 0
Pakistan
State/province [1] 6703 0
Swat/Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 290835 0
Charities/Societies/Foundations
Name [1] 290835 0
Elhra
Country [1] 290835 0
United Kingdom
Primary sponsor type
Charities/Societies/Foundations
Name
Human Development Research Foundation
Address
PO Box No. 759 G-10 Markaz Islamabad, 44000 Pakistan
Country
Pakistan
Secondary sponsor category [1] 289526 0
None
Name [1] 289526 0
Address [1] 289526 0
Country [1] 289526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292457 0
Ethics Review Board Postgraduate Medical Institute Lady Reading Hospital
Ethics committee address [1] 292457 0
Ethics committee country [1] 292457 0
Pakistan
Date submitted for ethics approval [1] 292457 0
Approval date [1] 292457 0
30/10/2014
Ethics approval number [1] 292457 0
Ethics committee name [2] 294437 0
World Health Organization Research Ethics Review Committee
Ethics committee address [2] 294437 0
Ethics committee country [2] 294437 0
Switzerland
Date submitted for ethics approval [2] 294437 0
14/11/2014
Approval date [2] 294437 0
22/01/2015
Ethics approval number [2] 294437 0
RPC705

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55386 0
Prof Atif Rahman
Address 55386 0
Institute of Psychology, Health and Society University of Liverpool Waterhouse Building, Block B, Brownlow Street Liverpool L69 3GL
Country 55386 0
United Kingdom
Phone 55386 0
+44(0)151 252 5509
Fax 55386 0
+44(0)151 252 5285
Email 55386 0
Atif.Rahman@liverpool.ac.uk
Contact person for public queries
Name 55387 0
Atif Rahman
Address 55387 0
Institute of Psychology, Health and Society University of Liverpool Waterhouse Building, Block B, Brownlow Street Liverpool L69 3GL
Country 55387 0
United Kingdom
Phone 55387 0
+44(0)151 252 5509
Fax 55387 0
+44(0)151 252 5285
Email 55387 0
Atif.Rahman@liverpool.ac.uk
Contact person for scientific queries
Name 55388 0
Atif Rahman
Address 55388 0
Institute of Psychology, Health and Society University of Liverpool Waterhouse Building, Block B, Brownlow Street Liverpool L69 3GL
Country 55388 0
United Kingdom
Phone 55388 0
+44(0)151 252 5509
Fax 55388 0
+44(0)151 252 5285
Email 55388 0
Atif.Rahman@liverpool.ac.uk

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
No additional documents have been identified.