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Trial registered on ANZCTR


Registration number
ACTRN12616001630404
Ethics application status
Approved
Date submitted
1/11/2016
Date registered
24/11/2016
Date last updated
24/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psycho-Educational Intervention For Common Mental Health Problems In Pregnant Women Exposed To Humanitarian Emergency
Scientific title
Evaluating feasibility and acceptability of a Psycho-educational intervention for pregnant women with common mental disorders in rural Pakistan: a randomized controlled feasibility trial
Secondary ID [1] 290444 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 300808 0
Social support 300809 0
Help seeking for Psychological distress 300810 0
Condition category
Condition code
Mental Health 300626 300626 0 0
Anxiety
Mental Health 300627 300627 0 0
Depression
Mental Health 300628 300628 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: Psycho-educational sessions. Arm 2: Routine care. The intervention arm received an initial introductory session of 20 minutes duration regarding the intervention with each participant's family; for family buy in and participation in the next visit. This was followed by the main session of around one hour duration to the whole family in their home by the local community health worker. The intervention focuses attention on maternal psycho-social well-being, associating it with the optimal growth and development of the unborn child. The main areas of the intervention were empathetic listening, availability of social support, ensuring the pregnant woman regarding the circle of support that is available, domestic peace, balanced diet, rest, engagement of the pregnant woman in pleasurable activities, routine check-up during pregnancy, consulting doctor in case the distress is not relieved and maintenance of household peace and harmony throughout. These were described as steps for the health and well-being of the pregnant woman and her unborn child. Each of these steps has a maternal well-being message for the whole family. The intervention uses a simple pictorial approach of paired illustrations with one showing unwanted behaviors and the other positive actions to achieve the desired outcome of support for the mother and were designed specifically for this intervention. The duration of the study for any participant will conclude after two months follow-up assessment post intervention.
Intervention code [1] 296292 0
Behaviour
Intervention code [2] 296293 0
Treatment: Other
Comparator / control treatment
Arm 2: Routine care was conducted by the local community health workers (LHWs) to the control arm participants as is their routine official duty. During their routine visits LHWs conduct educational sessions (awareness for prevention of common diseases) and also provide the household with routine over the counter medicine for common ailments along with iron and folic acids. The duration of the study for any participant will conclude after two months follow-up assessment after study enrollment.
Control group
Active

Outcomes
Primary outcome [1] 300039 0
Help-seeking for psychological distress by pregnant women

This was assessed at the end of the trial . This was determined through a semi-structured approach by a researcher blind to allocation status at 2 months post-intervention. The information was obtained directly from the women’s LHW. The LHWs were asked whether anyone in the family of the distressed pregnant woman had contacted them for assistance with the mental health of the pregnant woman in the two months after the psycho-educational sessions. As the LHWs were the first point of contact for the women, they were considered to be the best source for this information.
Timepoint [1] 300039 0
Pretreatment (week 1), posttreatment (week 9)
Secondary outcome [1] 328877 0
Psychological distress as measured by the Self-Reporting Questionnaire (SRQ-20)
Timepoint [1] 328877 0
Pretreatment (week 1), posttreatment (week 9)
Secondary outcome [2] 328878 0
Perceived Social Support as measured by means scores on the Multidimensional Scale of Perceived Social Support (MSPSS)
Timepoint [2] 328878 0
Pretreatment (week 1), posttreatment (week 9)

Eligibility
Key inclusion criteria
SRQ score of >8 at any stage of their pregnancy were eligible for participation in the study.

All the participants were sourced from the cross sectional study that has been published and referenced as below.
Khan, M. N., Chiumento, A., Dherani, M., Bristow, K., Sikander, S., and Rahman, A (2015). Psychological distress and its associations with past events in pregnant women affected by armed conflict in Swat, Pakistan: a cross sectional study. Conflict and Health. 2015; 9(1).
Minimum age
15 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Participants with suicidal intent
b) Severe mental or medical illness
c) Recently given birth
d) Living with another women with an SRQ score of 9 or above.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were pregnant women identified from a cross sectional study conducted in the earlier phase of the research in the local area, through predefined inclusion and exclusion criteria along with the baseline data. The unit of randomization was individual trial participants. Randomization was done by a researcher at the independent trial center at the Human Development Research Foundation who was not involved in intervention delivery, clinical supervision, independent assessment or other aspects of the day-to-day running of the study. The trial participants were randomized to the intervention and routine care arm, using a 1:1 allocation ratio.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was done through a computer generated system using 1:1 allocation ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
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] 8365 0
Pakistan
State/province [1] 8365 0
Swat/Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 294852 0
Charities/Societies/Foundations
Name [1] 294852 0
Human Development Research Foundation
Address [1] 294852 0
House 06, Street 55, F-7/4 Islamabad postcode: 44000
Country [1] 294852 0
Pakistan
Primary sponsor type
Charities/Societies/Foundations
Name
Human Development Research Foundation
Address
House 06, Street 55, F-7/4 Islamabad postcode: 44000
Country
Pakistan
Secondary sponsor category [1] 293692 0
None
Name [1] 293692 0
Address [1] 293692 0
Country [1] 293692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296238 0
Ethics Review Committee, University of Liverpool
Ethics committee address [1] 296238 0
Ethics committee country [1] 296238 0
United Kingdom
Date submitted for ethics approval [1] 296238 0
12/12/2011
Approval date [1] 296238 0
13/02/2012
Ethics approval number [1] 296238 0
UoL000851

Summary
Brief summary
This was a feasibility trial of an intervention to raise awareness about psychological distress in pregnant women living in a post-conflict setting, The rationale of the study was to evaluate the feasibility and acceptability of the research procedures in pregnant women in low-resources settings affected by humanitarian emergency. This study compares the relative efficacy of (a) Psycho-educational intervention and (b) Routine care. It is hypothesized that Psycho-educational intervention will lead to increase in uptake of services/help for their psychological distress than routine care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61746 0
A/Prof Muhammad Naseem Khan
Address 61746 0
Institute of Public Health and Social Sciences, Khyber Medical University, Phase 5, Hayatabad Peshawar, postcode 25000.
Country 61746 0
Pakistan
Phone 61746 0
+923339482238
Fax 61746 0
Email 61746 0
drnasim@kmu.edu.pk
Contact person for public queries
Name 61747 0
A/Prof Muhammad Naseem Khan
Address 61747 0
Institute of Public Health and Social Sciences, Khyber Medical University, Phase 5, Hayatabad Peshawar, postcode 25000.
Country 61747 0
Pakistan
Phone 61747 0
+923339482238
Fax 61747 0
Email 61747 0
drnasim@kmu.edu.pk
Contact person for scientific queries
Name 61748 0
A/Prof Muhammad Naseem Khan
Address 61748 0
Institute of Public Health and Social Sciences, Khyber Medical University, Phase 5, Hayatabad Peshawar, postcode 25000.
Country 61748 0
Pakistan
Phone 61748 0
+923339482238
Fax 61748 0
Email 61748 0
drnasim@kmu.edu.pk

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