Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000662369
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
8/05/2017
Date last updated
9/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot RCT to assess the feasibility of conducting a peer based low­-intensity psychosocial intervention for reducing depressive symptoms in pregnant women in rural Bangladesh.
Scientific title
A pilot RCT to assess the feasibility of conducting a peer based low-­intensity psychosocial intervention for reducing depressive symptoms in pregnant women in rural Bangladesh.
Secondary ID [1] 291627 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate depressive symptoms during pregnancy 302749 0
Condition category
Condition code
Mental Health 302267 302267 0 0
Depression
Reproductive Health and Childbirth 302517 302517 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention selected for this study is the antenatal part of the Thinking Healthy Peer-delivered Program (THPP). THPP is a low-intensity cognitive behavioral therapy based intervention that is designed specifically for addressing mild to moderate depressive symptoms during and after pregnancy. In this current study, six peers (local mothers selected from the community) will deliver the session to intervention group participants. The intervention consists of five sessions. The sessions will be delivered on weekly basis for five weeks. Each session will require around forty-five minutes to one hour to deliver. Out of five sessions, first four sessions are individual face-to face sessions. And the final session is a group session, which includes groups of five or six intervention group participants. The sessions will be delivered in the intervention group participant’s home or any other place of conveniences.
The complete THPP consists of 14 sessions, which is delivered for 6 months across both antenatal and postnatal period of pregnancy. The programme is developed with the aim to extend the mental health care in rural low resource settings of low middle-income countries (LMICS). THPP is a modified and simpler version of another World Health Organisation (WHO) approved intervention, named as Thinking Healthy Programme (THP). The THP is the first intervention to be approved by WHO as part of its Mental Health Gap Action Programme that aims to scale up the mental health services for LMICs by the year 2020. A team of researcher from Human Development Research Foundation of Pakistan developed both THPP and THP.
In this current study, only the antenatal part of THPP is selected to evaluate the acceptability and feasibility of the part of the program as a stand-alone peer delivered intervention that might help in reducing depressive symptoms in rural pregnant women residing in low- middle-income countries like Bangladesh. Pregnant women participants will be divided into control and intervention groups to evaluate (i) differences in depressive symptoms in the intervention group after receiving the intervention, and (ii) comparison of depressive symptoms between groups. Peers selected from the local community will be trained to deliver the intervention. The outcome of the trial will be based on the data collected before and after intervention delivery.
The student researcher will receive a two-day training through Skype from one of the master trainer of the original THPP team. After the training, the student researcher will train the peers. Same training materials used in the original RCT of THPP will be used in this current study. The THPP team will also provide monthly supervision in order to ensure that the intervention has been delivered appropriately.
At the end of the intervention delivery, all six peers and 18-20 intervention group participants will take part in a small process evaluation. It will include interviews using semi-structured interview schedules that contain both quantitative and qualitative questions. The process evaluation aims to explore the peers and the intervention groups perception about the intervention. All the interviews during the process evaluation will be audiotaped and transcribed verbatim. This is considered the most useful way to assess an intervention trial. The participants’ in process evaluation will also be asked to complete a list of open and close end questions and rate the multiple components of the project (provider training standard, treatment receipt, treatment delivery, treatment enactment) on a Likert scale. This will help to maintain the overall treatment fidelity of the intervention. The process evaluation will also strengthen the results of RCTs and give an in-depth understanding of what makes the intervention a success or failure.
Description of the sessions:
Session 1 : The introductory session in which peers introduce themselves to the pregnant women and her family. Peers will explain about the THPP programme and set the ground rules for participation. Peers will also talk about family support and encourage family members for active participation in the programme.
Session 2: Session two focuses on pregnant women's personal health and peers will teach the pregnant women to apply the Thinking Healthy Approach to improve their personal health during their pregnancy.

Session 3: Session 3 focuses on improving pregnant women's relationship with people around her through applying Thinking Healthy approach.
Session 4: Session 4 focuses on improving pregnant women's relationship with her unborn child through applying Thinking healthy approach.
Session 5 or Group session: The group session focuses on promoting healthy eating and rest in pregnant women.
In each session Pregnant women's mood are assessed and review of the previous session will be done. After each session pregnant women's will be provided with health charts and asked to fill up the charts as part of homework.
Intervention code [1] 297699 0
Treatment: Other
Intervention code [2] 297853 0
Prevention
Comparator / control treatment
The control group will continue with the as-usual standard antenatal care available in the data collection site. In addition they will receive a brochure for containing information on mild to moderate depressive symptoms during pregnancy. The short brochure given to the control group will contains basic information on antepartum depressive symptoms e.g., definition, symptoms, treatment option, where to seek help etc. The brochure will be specifically designed for the study.
Control group
Active

Outcomes
Primary outcome [1] 301682 0
Change in depressive symptoms via Mean Patient Health questionnaire -9 (PHQ-9) score.
Timepoint [1] 301682 0
At baseline, 6weeks and 8 weeks after intervention commencement.
Primary outcome [2] 302019 0
Change in quality of life via Mean WHOQOL-BREF score.
Timepoint [2] 302019 0
At baseline, 6 and 8 weeks after intervention commencement.
Primary outcome [3] 302020 0
Change in self esteem via Mean Rosenberg SelfEsteem(RSS) scale score.
Timepoint [3] 302020 0
At baseline, 6 weeks and 8 weeks of intervention commencement.
Secondary outcome [1] 333550 0
To determine whether the selected intervention is feasible and acceptable by local community to carry out in the rural low-resource settings of Bangladesh. The secondary outcome will be assessed during the process evaluation through interviews with intervention group pregnant women and peers. separate semi-structured interview schedules for intervention group participants and peers will be used to carry out the process evaluation.
Timepoint [1] 333550 0
At 6-8 weeks of intervention delivery.

Eligibility
Key inclusion criteria
1) Two groups of participants will be included in the study. Peers and pregnant women. Six peers from the local community will be selected to deliver the intervention to intervention group pregnant women. 70 pregnant women will be divided equally in control and intervention group to compare any changes that the selected intervention might have.
Inclusion criteria for pregnant women:
*Pregnant women between 20 and 30 weeks’ gestation.
*Aged 18 years or above.
*Scoring 10-14 on the Patient Health Questionnaire (PHQ-9).

Inclusion criteria for peer:
*Local women sharing similar experience, such as being a mother with similar characteristic like age, religion, ethnicity or socioeconomic status.
*Having at least 10th grade school level education or more.

Please note that, peer will be healthy volunteers included in the study to deliver the intervention to the pregnant women suffering from mild to moderate depressive symptoms as measured through the depression screening tool (PHQ-9).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for pregnant women prior to and during the study
1. Severe depression with or without suicidal ideation.
2. PHQ 9 score more than 14.
3. Diagnosed with any acute medical complications during pregnancy or develops complications during participation in the study.
4. Currently receiving treatment for an acute episode of mental disorder or develops an acute episode during participation in the study.

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)
The randomisation process wil be carried out by the Principal Supervisor to maintain ‘allocation concealment’ and in accordance with the CONSORT guidelines for conducting RCTs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In this study, the intervention group participant will receive the selected intervention through peers. The control group will continue group participants will continue to receive as-usual care of pregnancy available in the local area and in addition, they will receive a short brochure containing basic information on antepartum depressive symptoms.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2017
Actual
28/08/2017
Date of last participant enrolment
Anticipated
31/08/2017
Actual
30/10/2017
Date of last data collection
Anticipated
31/12/2017
Actual
30/01/2018
Sample size
Target
70
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 8779 0
Bangladesh
State/province [1] 8779 0
Cox's Bazar district, Chittagong division

Funding & Sponsors
Funding source category [1] 296117 0
University
Name [1] 296117 0
Victoria university
Country [1] 296117 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
College of Health & Biomedicine, Victoria University, McKechnie St, St Albans VIC 3021, Australia
Country
Australia
Secondary sponsor category [1] 295018 0
None
Name [1] 295018 0
Address [1] 295018 0
Country [1] 295018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297375 0
Victoria University Human Research ethics Committee
Ethics committee address [1] 297375 0
Victoria University, PO Box 14428, Melbourne, VIC, 8001,
Ethics committee country [1] 297375 0
Australia
Date submitted for ethics approval [1] 297375 0
27/08/2016
Approval date [1] 297375 0
13/04/2017
Ethics approval number [1] 297375 0
HR 16-180
Ethics committee name [2] 300093 0
Bangladesh Medical Research Council
Ethics committee address [2] 300093 0
BMRC Bhavan, Mohakhali, Dhaka, 1212.
Ethics committee country [2] 300093 0
Bangladesh
Date submitted for ethics approval [2] 300093 0
19/06/2017
Approval date [2] 300093 0
04/09/2017
Ethics approval number [2] 300093 0
055 19 6 2017

Summary
Brief summary
Background: Antepartum depression or depression during pregnancy is a public health concern due to its adverse impact on the mother’s and child’s health. Despite of high prevalence of antepartum depression, many women have limited or no access to mental health care facilities in rural LMIC's. Furthermore, a suitable intervention for these regions, that is of low cost and non­ professional based, focusing solely on depressive symptoms during pregnancy could not be found in existing literature. In light of these problems, the aim of the proposed study is to explore feasibility and acceptability of part of an evidence-­based peer­ based intervention to reduce early depressive symptoms in pregnant women.
Objective: To examine feasibility and acceptability of conducting a peer based low intensity psychosocial intervention in reducing mild to moderate depressive symptoms in pregnant women in rural Bangladesh.
Methods: A mixed methods approach incorporating a pilot randomised control trial (RCT) and a qualitative process evaluation will be used in this study. Participants pregnant women will be randomised into into control and intervention groups. The intervention group will receive a peer based, CBT intervention for 5 weeks and control group will continue with the as­usual care. Data collected from control and intervention group at the end of the intervention delivery will be compared for final outcome of the pilot trial.
For the process evaluation, intervention group participants and peers will also take part in a semi­structured interview to reflect their views on the intervention.
Conclusion: The outcomes of the study will evaluate the feasibility and acceptability of the selected intervention as a stand­alone intervention in reducing antepartum depressive symptoms among rural pregnant women and potential of peer based intervention in primary health care settings in LMICs countries like Bangladesh.
Trial website
Trial related presentations / publications
Public notes
This pilot RCT will use the antenatal section of Thinking Healthy Program Peer Delivered (THPP) as the intervention. The aim is to examine the feasibility of the selected part as a stand alone intervention for reducing mild to moderate depressive symptoms among women residing in a rural region of Bangladesh. The ethical approval for the project has been obtained from Victoria University Human Research Ethics Commitee and from Bangladesh Medical Research Council.

Contacts
Principal investigator
Name 73842 0
Prof Terence McCann
Address 73842 0
College of Health & biomedicine, Victoria University, McKechnie St, St Albans VIC 3021, Australia
Country 73842 0
Australia
Phone 73842 0
+61 3 9919 2325
Fax 73842 0
Email 73842 0
[email protected]
Contact person for public queries
Name 73843 0
Dr Rehenuma Tarannum
Address 73843 0
College of Health & biomedicine, Victoria University, McKechnie St, St Albans VIC 3021, Australia
Country 73843 0
Australia
Phone 73843 0
+61 3 9919 6100
Fax 73843 0
Email 73843 0
[email protected]
Contact person for scientific queries
Name 73844 0
Mrs Rehenuma Tarannum
Address 73844 0
College of Health & biomedicine, Victoria University, McKechnie St, St Albans VIC 3021, Australia
Country 73844 0
Australia
Phone 73844 0
+61 3 9919 6100
Fax 73844 0
Email 73844 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23509Ethical approval   
23510Clinical study report   
23511Statistical analysis plan   
23512Study protocol   

Results publications and other study-related documents

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