Maternal DepressionTechMotherNCT02526355
Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
A study testing Mobile based intervention in people with Maternal Depression, run by Pakistan Institute of Living and Learning at 3 sites in Pakistan.
Trial summary
The prevalence rate of maternal depression in Pakistani women and its effect on the growth and development of young children and child mortality is very high. The main objective of this study is to increase access to evidence based psychological interventions for mothers who have children of age 0 to 30 months… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Maternal Depression
- What is being tested?
- Mobile based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 3 sitesPakistan
- Study dates
- Jan 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mothers with mild to moderate depression will be included
- Mother of children age 0-30months
- The age range in the study is 18 to 44 years
- Participants having mobile phones will be included
Who cannot join
- Subjects will not be included if they had a diagnosed medical condition or significant physical or learning disability
- Any form of psychosis, or are currently under psychiatric care.
- Mothers with severe depression or suicidal ideation will not be included
- Mothers who will be receiving any psychological intervention will be excluded
- Mothers of children with any serious medical or psychiatric illness will also be excluded.
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Chiniot Maternity Hospital
Karachi, Sindh
Sobhraj Maternity hospital
Karachi, Sindh
Jinnah Hospital
Lahore, Punjab Province, +92
About this study
The prevalence rate of maternal depression in Pakistani women and its effect on the growth and development of young children and child mortality is very high.
The main objective of this study is to increase access to evidence based psychological interventions for mothers who have children of age 0 to 30 months, consistent with her values. The study will be a 2 (conditions) into 3 (Time) single blind randomized controlled trail. Depressed mothers will be randomized either to intervention arm or control arm. Intervention will include text messages based on Learning Through Play Plus (LTP plus CBT).
Read the detailed description
Disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. There are a number of efficient treatments for postnatal depression including antidepressant medication, psychotherapy and psychosocial interventions. Tele-health and mobile health is a novel and emerging field in psychiatric and psychological care and treatment of mental health difficulties, it involves the use of telecommunications to provide health care, support and intervention from a distance.
The proposed study will test the efficacy of an innovative, affordable mobile based intervention program that can help mothers with postnatal depression in low resource countries such as Pakistan.
Participants will be recruited from maternal and child care centres in Karachi, Pakistan and those participants (n = 204) meeting inclusion criteria of the study will be randomized into one of the 2 treatment arms, i.e., intervention or control, after completion of baseline assessment. Intervention will be comprised of LTP Plus and will be delivered through text messages. Momentary Sampling assessment and Momentary Psychological intervention will be part of this study. Participants will be assessed again after completion of intervention (i.e., after 12 weeks) and then 3 months post intervention.
- Conditions
- Maternal Depression
- Being tested
- Mobile based intervention
- Keywords
- Maternal depression, Mobile phone based intervention, Learning Through Play, CBT, Intelligent Real Time Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile based interventionBehavioural
Also called Intelligent Real Time Therapy iRTT
Learning through Play Plus Intervention delivered through mobile phone
| Study group | Role | What they receive |
|---|---|---|
| Mobile based Intervention | Experimental | Mobile based Intervention (Learning Through Play Plus) comprised of both LTP and CBT Receives: Behavioral: Mobile based intervention |
| Waiting List Control | No intervention | Waiting List Control group will receive no intervention, but intervention will be offered to interested participants at the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale (EPDS)
EPDS will be used to screen depression in mothers with child 0-30 months.
Measured: change in scores from baseline to 3rd month and 6th month
Secondary outcomes (7)
Patient Health Questionnaire (PHQ-9)
PHQ-9 will be used to assess the severity of depression
Measured: change in scores from baseline to 3rd month and 6th month
EuroQoL-5 Dimensions (EQ-5D)
EQ-5D will be used to assess the health related quality of life
Measured: change in scores from baseline to 3rd month and 6th month
Generalized Anxiety Disorder - 7 (GAD-7)
GAD 7 will be used to assess severity of anxiety.
Measured: change in scores from baseline to 3rd month and 6th month
Knowledge of Expectation and Child Development
25-item questionnaire will be used to assess maternal knowledge and expectations for child development in the first three years. Higher scores indicate better outcomes.
Measured: change in scores from baseline to 3rd month and 6th month
Clinical Interview Schedule Revised (CISR)
The clinical Interview Schedule-Revised is a structured diagnostic instrument that was developed from the Clinical Interview Schedule (CIS), to assess psychiatric problems
Measured: Change in scores from baseline to 3rd month and 6th month
Assessment of the growth and development of children (Weight)
Anthropometric measures of child growth will be collected through measuring children's weight in kilograms. weight and height will be combined to report BMI in kg/m^2
Measured: Change in scores from Baseline and 6 month
Assessment of the growth and development of children (Height)
Anthropometric measures of child growth will be collected through measuring children height in meters. weight and height will be combined to report BMI in kg/m^2
Measured: Change in scores from Baseline and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nusrat Husain, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526355
- Sponsor's protocol ID
- TechMotherCare001
- Acronym
- TechMother
- Status last verified
- Apr 2022
- First submitted
- 15 Nov 2014
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
- ClinicalTrials.gov ID
- NCT02526355
- Acronym / sponsor ID
- TechMother / TechMotherCare001
- Conditions
- Maternal Depression
- Keywords
- Maternal depression, Mobile phone based intervention, Learning Through Play, CBT, Intelligent Real Time Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence rate of maternal depression in Pakistani women and its effect on the growth and development of young children and child mortality is very high.
The main objective of this study is to increase access to evidence based psychological interventions for mothers who have children of age 0 to 30 months, consistent with her values. The study will be a 2 (conditions) into 3 (Time) single blind randomized controlled trail. Depressed mothers will be randomized either to intervention arm or control arm. Intervention will include text messages based on Learning Through Play Plus (LTP plus CBT).
Detailed description
Disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. There are a number of efficient treatments for postnatal depression including antidepressant medication, psychotherapy and psychosocial interventions. Tele-health and mobile health is a novel and emerging field in psychiatric and psychological care and treatment of mental health difficulties, it involves the use of telecommunications to provide health care, support and intervention from a distance.
The proposed study will test the efficacy of an innovative, affordable mobile based intervention program that can help mothers with postnatal depression in low resource countries such as Pakistan.
Participants will be recruited from maternal and child care centres in Karachi, Pakistan and those participants (n = 204) meeting inclusion criteria of the study will be randomized into one of the 2 treatment arms, i.e., intervention or control, after completion of baseline assessment. Intervention will be comprised of LTP Plus and will be delivered through text messages. Momentary Sampling assessment and Momentary Psychological intervention will be part of this study. Participants will be assessed again after completion of intervention (i.e., after 12 weeks) and then 3 months post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile based Intervention | Experimental | Behavioral: Mobile based interventionMobile based Intervention (Learning Through Play Plus) comprised of both LTP and CBT |
| Waiting List Control | No intervention | –Waiting List Control group will receive no intervention, but intervention will be offered to interested participants at the end of the study |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mothers with mild to moderate depression will be included
- Mother of children age 0-30months
- The age range in the study is 18 to 44 years
- Participants having mobile phones will be included
Key exclusion criteria (5 listed)
- Subjects will not be included if they had a diagnosed medical condition or significant physical or learning disability
- Any form of psychosis, or are currently under psychiatric care.
- Mothers with severe depression or suicidal ideation will not be included
- Mothers who will be receiving any psychological intervention will be excluded
- Mothers of children with any serious medical or psychiatric illness will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile based interventionAlso: Intelligent Real Time Therapy iRTTLearning through Play Plus Intervention delivered through mobile phone | Behavioural | Mobile based Intervention |
Primary outcome
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: change in scores from baseline to 3rd month and 6th month
EPDS will be used to screen depression in mothers with child 0-30 months.
7 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: change in scores from baseline to 3rd month and 6th month
EuroQoL-5 Dimensions (EQ-5D)
Time frame: change in scores from baseline to 3rd month and 6th month
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: change in scores from baseline to 3rd month and 6th month
Knowledge of Expectation and Child Development
Time frame: change in scores from baseline to 3rd month and 6th month
Clinical Interview Schedule Revised (CISR)
Time frame: Change in scores from baseline to 3rd month and 6th month
Assessment of the growth and development of children (Weight)
Time frame: Change in scores from Baseline and 6 month
Assessment of the growth and development of children (Height)
Time frame: Change in scores from Baseline and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nusrat Husain, MD principal investigator
University of Manchester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile based intervention in people with Maternal Depression, run by Pakistan Institute of Living and Learning at 3 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (EPDS) (time frame: change in scores from baseline to 3rd month and 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.