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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12616001630404
Date of registration: 24/11/2016
Prospective Registration: No
Primary sponsor: Human Development Research Foundation
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
Date of first enrolment: 01/09/2012
Target sample size: 60
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12616001630404.aspx
Study type:  Interventional
Study design:  Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Pakistan
Contacts
Name: A/Prof Muhammad Naseem Khan   
Address:  Institute of Public Health and Social Sciences, Khyber Medical University, Phase 5, Hayatabad Peshawar, postcode 25000. Pakistan
Telephone: +923339482238
Email: drnasim@kmu.edu.pk
Affiliation: 
Name: A/Prof Muhammad Naseem Khan   
Address:  Institute of Public Health and Social Sciences, Khyber Medical University, Phase 5, Hayatabad Peshawar, postcode 25000. Pakistan
Telephone: +923339482238
Email: drnasim@kmu.edu.pk
Affiliation: 
Key inclusion & exclusion criteria
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).

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.


Age minimum: 15 Years
Age maximum: 45 Years
Gender: Females
Health Condition(s) or Problem(s) studied
Mental Health - Other mental health disorders
Mental Health - Depression
Mental Health - Anxiety
Psychological distress;Social support;Help seeking for Psychological distress;
Psychological distress
Social support
Help seeking for Psychological distress
Intervention(s)
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.
Primary Outcome(s)
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. [Pretreatment (week 1), posttreatment (week 9)]
Secondary Outcome(s)
Perceived Social Support as measured by means scores on the Multidimensional Scale of Perceived Social Support (MSPSS) [Pretreatment (week 1), posttreatment (week 9)]
Psychological distress as measured by the Self-Reporting Questionnaire (SRQ-20)[Pretreatment (week 1), posttreatment (week 9)]
Secondary ID(s)
Nil
Source(s) of Monetary Support
Human Development Research Foundation
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Ethics Review Committee, University of Liverpool
Results
Results available:
Date Posted:
Date Completed:
URL:
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