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Trial registered on ANZCTR


Registration number
ACTRN12614001244695
Ethics application status
Approved
Date submitted
30/10/2014
Date registered
27/11/2014
Date last updated
22/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low Intensity Intervention to Reduce Depression and Anxiety in People Exposed to Adversity
Scientific title
Exploratory Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual to Reduce Depression and Anxiety in People Exposed to Adversity
Secondary ID [1] 285563 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 293569 0
Depression 293575 0
Condition category
Condition code
Mental Health 293673 293673 0 0
Depression
Mental Health 293812 293812 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] 290514 0
Behaviour
Intervention code [2] 290707 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 workshop on identification and management of mental disorders. 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] 293483 0
Anxiety and depression are a composite outcome that are measured by mean score on the General Health Questionnaire
Timepoint [1] 293483 0
Pretreatment (week 1), posttreatment (week 7)
Secondary outcome [1] 311144 0
Mean scores on the World Health Organization Disability Assessment Schedule 2.0
Timepoint [1] 311144 0
Pretreatment (week 1), posttreatment (week 7)
Secondary outcome [2] 311145 0
Mean scores on the Posttraumatic Stress Disorder Checklist
Timepoint [2] 311145 0
Pretreatment (week 1), posttreatment (week 7)

Eligibility
Key inclusion criteria
GHQ >1 and WHODAS>16
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, (d) acute protections risks (e) exposure to trauma in last month.

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)
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 randomisation table created by a computerised 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
Since this is a small exploratory RCT (to inform a definitive RCT) that does not aim to detect statistically significant differences in effectiveness, no power calculations have been carried out. Outcome measures will comprise the GHQ, PCL, 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] 6444 0
Pakistan
State/province [1] 6444 0
Peshawar

Funding & Sponsors
Funding source category [1] 290167 0
Government body
Name [1] 290167 0
Office of US Foreign Disaster Assistance (OFDA)
Address [1] 290167 0
2201 C St NW, Washington, DC 20520
Country [1] 290167 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Human Development Research Foundation
Address
PO Box No. 759
G-10 Markaz
Islamabad, 4400
Country
Pakistan
Secondary sponsor category [1] 288878 0
None
Name [1] 288878 0
Address [1] 288878 0
Country [1] 288878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291876 0
World Health Organisation Ethics Review Committee
Ethics committee address [1] 291876 0
Avenue Appia 20
1211 Geneva 27
Switzerland
Ethics committee country [1] 291876 0
Switzerland
Date submitted for ethics approval [1] 291876 0
Approval date [1] 291876 0
23/12/2013
Ethics approval number [1] 291876 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-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
NA
Public notes

Contacts
Principal investigator
Name 52382 0
Prof Atif Rahman
Address 52382 0
Institute of Psychology, Health and Society
University of Liverpool
Waterhouse Building, Block B, Brownlow Street,
Liverpool L69 3GL
Country 52382 0
United Kingdom
Phone 52382 0
+44(0)151 252 5509
Fax 52382 0
+44(0)151 252 5285
Email 52382 0
Atif.Rahman@liverpool.ac.uk
Contact person for public queries
Name 52383 0
Prof Atif Rahman
Address 52383 0
Institute of Psychology, Health and Society
University of Liverpool
Waterhouse Building, Block B, Brownlow Street,
Liverpool L69 3GL
Country 52383 0
United Kingdom
Phone 52383 0
+44(0)151 252 5509
Fax 52383 0
+44(0)151 252 5285
Email 52383 0
Atif.Rahman@liverpool.ac.uk
Contact person for scientific queries
Name 52384 0
Prof Atif Rahman
Address 52384 0
Institute of Psychology, Health and Society
University of Liverpool
Waterhouse Building, Block B, Brownlow Street,
Liverpool L69 3GL
Country 52384 0
United Kingdom
Phone 52384 0
+44(0)151 252 5509
Fax 52384 0
+44(0)151 252 5285
Email 52384 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