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Trial registered on ANZCTR


Registration number
ACTRN12614001235695
Ethics application status
Approved
Date submitted
30/10/2014
Date registered
26/11/2014
Date last updated
10/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low Intensity Intervention to Reduce Posttraumatic Stress in People Exposed to Adversity
Scientific title
Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual to Reduce Posttraumatic Stress in People Exposed to Adversity
Secondary ID [1] 285567 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 293398 0
Posttraumatic stress disorder 293574 0
Condition category
Condition code
Mental Health 293677 293677 0 0
Anxiety
Mental Health 293858 293858 0 0
Depression

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 a 3-month follow-up assessment, resulting in participation duration of 4.5 months. Therapy is provided by local health workers.
Intervention code [1] 290518 0
Behaviour
Intervention code [2] 290654 0
Treatment: Other
Comparator / control treatment
Enhanced Treatment as Usual comprises normal treatment provided by local physicians who will receive a single 2-day refresher training on identification and management of mental disorders. The duration of the study for any participant will conclude after a 3-month follow-up assessment, resulting in participation duration of 4.5 months.
Control group
Active

Outcomes
Primary outcome [1] 293491 0
Anxiety as measured by mean scores on the Hospital Anxiety and Depression Scale


Timepoint [1] 293491 0
Pretreatment (week 1), posttreatment (week 7), 3 Month Follow Up (week 15)
Primary outcome [2] 293492 0
Depression as measured by mean scores on the Hospital Anxiety and Depression Scale
Timepoint [2] 293492 0
Pretreatment (week 1), posttreatment (week 7), 3 Month Follow Up (week 15)
Secondary outcome [1] 311152 0
Functioning as measured by means scores on the World Health Organisation Disability Assessment Scale (WHODAS)
Timepoint [1] 311152 0
Pretreatment (week 1), posttreatment (week 7), 3 Month Follow Up (week 15)
Secondary outcome [2] 311153 0
Posttraumatic stress disorder as measured by means scores on the Posttraumatic Stress Disorder Checklist
Timepoint [2] 311153 0
Pretreatment (week 1), posttreatment (week 7), 3 Month Follow Up (week 15)
Secondary outcome [3] 328252 0
Personalised outcomes as measured by the Psychological Outcomes Profile (PSYCHLOPS) scale
Timepoint [3] 328252 0
Pretreatment (week 1), posttreatment (week 7), follow up (13)
Secondary outcome [4] 328253 0
Depression as measured by the PHQ-9
Timepoint [4] 328253 0
Pretreatment (week 1), posttreatment (week 7), follow up (13)

Eligibility
Key inclusion criteria
Inclusion criteria are GHQ >2 and WHODAS>16. There are no other inclusion criteria.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and 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 adults attend primary health care centers and indicating moderate distress & impaired functioning. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the study and who works at a site that is distant from the treatment centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minimization stratified by primary health care center.
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
Power calculations suggest a minimum sample size of 133 participants per group (power =.95, alpha = .05, 2-sided). Taking into account an expected 30% attrition at 3 months follow-up, we aim to include a total number of 346 participants (173 in each group, with an approximate equal number of men as women). The thrust of analyses will be using hierarchical linear models (HLM) to investigate the relative effects of the treatments. Analyses will be conducted using Mplus (version 7.11). 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 by using the maximum likelihood estimator, which provides the optimal estimates of model parameter values and standard errors. 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 HADS and WHODAS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6446 0
Pakistan
State/province [1] 6446 0
Peshawar

Funding & Sponsors
Funding source category [1] 290170 0
Charities/Societies/Foundations
Name [1] 290170 0
Elhra
Address [1] 290170 0
1 St John's Lane,London EC1M 4AR
Country [1] 290170 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] 288881 0
None
Name [1] 288881 0
Address [1] 288881 0
Country [1] 288881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291879 0
Postgraduate Medical Institute
Ethics committee address [1] 291879 0
Government Lady Reading Hospital Peshawar
Peshawar, 25000
Ethics committee country [1] 291879 0
Pakistan
Date submitted for ethics approval [1] 291879 0
Approval date [1] 291879 0
13/08/2014
Ethics approval number [1] 291879 0

Summary
Brief summary
The rationale of the study is to evaluate the efficacy of a low intensity intervention to reduce mental health problems in people in low-resources settings. This study compares the relative efficacy of (a) Problem Management Plus, and (b) Enhanced Treatment as Usual. It is hypothesised that Problem Management Plus will lead to greater symptom reduction than Enhanced Treatment as Usual.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52394 0
Prof Atif Rahman
Address 52394 0
Institute of Psychology, Health and Society
University of Liverpool
Waterhouse Building, Block B, Brownlow Street
Liverpool L69 3GL
Country 52394 0
United Kingdom
Phone 52394 0
+44(0)151 252 5509
Fax 52394 0
+44(0)151 252 5285
Email 52394 0
Atif.Rahman@liverpool.ac.uk
Contact person for public queries
Name 52395 0
Prof Atif Rahman
Address 52395 0
Institute of Psychology, Health and Society
University of Liverpool
Waterhouse Building, Block B, Brownlow Street
Liverpool L69 3GL
Country 52395 0
United Kingdom
Phone 52395 0
+44(0)151 252 5509
Fax 52395 0
+44(0)151 252 5285
Email 52395 0
Atif.Rahman@liverpool.ac.uk
Contact person for scientific queries
Name 52396 0
Prof Atif Rahman
Address 52396 0
Institute of Psychology, Health and Society
University of Liverpool
Waterhouse Building, Block B, Brownlow Street
Liverpool L69 3GL
Country 52396 0
United Kingdom
Phone 52396 0
+44(0)151 252 5509
Fax 52396 0
+44(0)151 252 5285
Email 52396 0
Atif.Rahman@liverpool.ac.uk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary