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Trial registered on ANZCTR


Registration number
ACTRN12616000037404
Ethics application status
Approved
Date submitted
23/11/2015
Date registered
19/01/2016
Date last updated
8/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low Intensity Intervention to Reduce Depression and Anxiety in women Exposed to Adversity
Scientific title
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] 287971 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 296848 0
Anxiety
 296849 0
Post Traumatic Stress Disorder 296850 0
Condition category
Condition code
Mental Health 297078 297078 0 0
Depression
Mental Health 297079 297079 0 0
Anxiety
Mental Health 297080 297080 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 once weekly over 5 weeks in a group format over 3 hours per session. 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 3 months follow-up assessment and resulting in participation duration of around 5 months. Therapy is provided by lay health counselors along with community health workers. Fidelity testing of 10-15% sessions will be done in the field.
Intervention code [1] 293314 0
Behaviour
Intervention code [2] 293315 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 5 months.
Control group
Active

Outcomes
Primary outcome [1] 296684 0
Anxiety as measured by mean scores on the Hospital Anxiety and Depression Scale
Timepoint [1] 296684 0
Pretreatment (week 1), 1st follow up posttreatment (week 7)and final follow up (week 20)
Primary outcome [2] 296685 0
Depression as measured by mean scores on the Hospital Anxiety and Depression Scale
Timepoint [2] 296685 0
Pretreatment (week 1), 1st follow up posttreatment (week 7) and final follow up (week 20)
Primary outcome [3] 299214 0
Anxiety and depression as measured by the combined mean scores on the Hospital Anxiety and Depression Scale
Timepoint [3] 299214 0
Pretreatment (week 1), 1st follow up posttreatment (week 7)and final follow up (week 20)
Secondary outcome [1] 319116 0
Functioning as measured by means scores on the World Health Organisation Disability Assessment Scale (WHODAS)
Timepoint [1] 319116 0
Pretreatment (week 1), 1st follow up posttreatment (week 7) and final follow up (week 20)
Secondary outcome [2] 319117 0
Posttraumatic stress disorder as measured by means scores on the Posttraumatic Stress Disorder Checklist
Timepoint [2] 319117 0
Pretreatment (week 1), 1st follow up posttreatment (week 7) and final follow up (week 20)
Secondary outcome [3] 319393 0
Cost-effectiveness as measured by the Service Receipt Inventory
Timepoint [3] 319393 0
Pretreatment (Week 1) and final follow up (Week 20)
Secondary outcome [4] 326531 0
Levels of social support measured by the Multi-Dimensional Scale of Perceived Social Support
Timepoint [4] 326531 0
Pretreatment (Week 1) and final follow up (Week 20)
Secondary outcome [5] 326532 0
Depressive disorder measured by the Primary Health Questionnaire
Timepoint [5] 326532 0
Pretreatment (week 1), 1st follow up posttreatment (week 7) and final follow up (week 20)
Secondary outcome [6] 326533 0
Self-report wellbeing as measured by the Psychological Outcomes Profile Instrument (PSYCHLOPS)
Timepoint [6] 326533 0
Pretreatment (week 1), 1st follow up posttreatment (week 7) and final follow up (week 20)

Eligibility
Key inclusion criteria
GHQ >2 and WHODAS>16
Minimum age
18 Years
Maximum age
60 Years
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 18-60 years screened in the community by the research team 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 Odigram and Ghalegay 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 Odigram and Ghalegay 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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/01/2016
Date of last participant enrolment
Anticipated
Actual
21/08/2016
Date of last data collection
Anticipated
Actual
30/12/2016
Sample size
Target
612
Accrual to date
Final
612
Recruitment outside Australia
Country [1] 7354 0
Pakistan
State/province [1] 7354 0
Swat/Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 292440 0
Charities/Societies/Foundations
Name [1] 292440 0
Elrha
Country [1] 292440 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] 291133 0
None
Name [1] 291133 0
Address [1] 291133 0
Country [1] 291133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293899 0
Research and Ethical Committee (REC) Rawalpindi Medical College
Ethics committee address [1] 293899 0
Ethics committee country [1] 293899 0
Pakistan
Date submitted for ethics approval [1] 293899 0
Approval date [1] 293899 0
31/08/2015
Ethics approval number [1] 293899 0
Ethics committee name [2] 293900 0
WHO Research Ethics Review Committee
Ethics committee address [2] 293900 0
Ethics committee country [2] 293900 0
Switzerland
Date submitted for ethics approval [2] 293900 0
Approval date [2] 293900 0
23/10/2015
Ethics approval number [2] 293900 0

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

Contacts
Principal investigator
Name 61750 0
Prof Atif Rahman
Address 61750 0
Institute of Psychology, Health and Society University of Liverpool Waterhouse Building, Block B, Brownlow Street Liverpool L69 3GL
Country 61750 0
United Kingdom
Phone 61750 0
+44(0)151 252 5509
Fax 61750 0
+44(0)151 252 5285
Email 61750 0
atif.rahman@liverpool.ac.uk
Contact person for public queries
Name 61751 0
Atif Rahman
Address 61751 0
Institute of Psychology, Health and Society University of Liverpool Waterhouse Building, Block B, Brownlow Street Liverpool L69 3GL
Country 61751 0
United Kingdom
Phone 61751 0
+44(0)151 252 5509
Fax 61751 0
+44(0)151 252 5285
Email 61751 0
atif.rahman@liverpool.ac.uk
Contact person for scientific queries
Name 61752 0
Atif Rahman
Address 61752 0
Institute of Psychology, Health and Society University of Liverpool Waterhouse Building, Block B, Brownlow Street Liverpool L69 3GL
Country 61752 0
United Kingdom
Phone 61752 0
+44(0)151 252 5509
Fax 61752 0
+44(0)151 252 5285
Email 61752 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
SourceTitleYear of PublicationDOI
EmbaseEvaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: Study protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s13063-017-1905-8
EmbaseEffectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial.2019https://dx.doi.org/10.1016/S0140-6736%2818%2932343-2
N.B. These documents automatically identified may not have been verified by the study sponsor.