Postnatal DepressionPhase 2NCT01309516
Randomised Control Trial of a Complex Intervention for Postnatal Depression
A Phase 2 study testing Complex Intervention in people with Postnatal Depression and Depression, Postpartum, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
Trial summary
The study aims to: 1. Develop a culturally appropriate psychosocial intervention 2. Test feasibility and acceptability of psychosocial intervention in women suffering from postnatal depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postnatal Depression, Depression, Postpartum
- What is being tested?
- Complex Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesPakistan
- Study dates
- May 2009to May 2011
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depressed mothers over the age of 18 years
- Having one or more infants 6-18 months old
- Ability to give informed consent
- Resident in the study catchment area
Who cannot join
- Women or child with diagnosed physical or learning disability and women having post-partum or other psychosis
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Civil hospital
Karachi, Sindh, 75600
Abbasi Shaheed hospital Karachi
Karachi, Sindh
About this study
Official title: Efficacy of Learning Through Play Plus Intervention to Reduce Maternal Depression for Women With Under-nourished Children: A Randomized Controlled Trial From Pakistan
The study aims to:
- Develop a culturally appropriate psychosocial intervention
- Test feasibility and acceptability of psychosocial intervention in women suffering from postnatal depression.
Read more
Primary Hypothesis:
Depressed mothers who will receive the group intervention will show significant improvements in terms of symptoms of depression.
Design:
Randomised controlled trial.
Setting:
Outpatient department of Civil hospital Karachi.
Participants:
A total of 84 depressed mothers will be randomised equally to an intervention group and a Treatment as usual control group.
Interventions:
The 12 session multimodal psychosocial intervention will be delivered to mothers in the intervention group over a three months period. Each session would take up to 45 minutes. Control group will receive standard postnatal follow-up.
Outcome measures:
Primary outcome measures would be mothers' scores on Edinburgh Postnatal Depression Scale (EPDS)and Hamilton Depression Rating Scale (HDRS).
Read the detailed description
A number of individual and group interventions targeting maternal depression have been developed and tested, mostly in developed countries. Group-based approaches have usually been used to improve outcomes in children through parent-training programmes. A meta-analysis of such programmes shows that these can also be effective in improving psychosocial and mental health of the mothers. However, a number of health system and cultural differences make it difficult for mental health interventions to be extrapolated from the developed to the developing world.
Design:
The interventions will be assessed using a prospective randomised controlled design, using two groups: psychosocial group therapy (Learning Through Play + principles of Cognitive Behaviour Therapy)and treatment as usual.
Defining the intervention:
The intervention will include a supportive component, an educational component, and practical advice on using health services, a parenting component, and a psychosocial component. The objective will be to help mothers feel supported, empowered and confident about their parenting abilities, which in turn may help to reduce their level of depression. Further qualitative testing of the intervention will take place to refine the manualized intervention.
Psychiatric Measures:
The level of severity of depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS) (Cox and Holden, 1994) and the Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960).
Women scoring 12 or over on the EPDS and 13 or over on the HDRS will be asked to undergo a diagnostic interview using the Clinical Interview Schedule-Revised (CIS-R).
To measure mother infant attachment the Maternal Attachment Inventory (Muller, 1994) will be used.
OSLO-3 item Social Support Scale (Dalgard, 1996) will be used to measure social support.
The adapted Verona Service Satisfaction Scale (Tansella, 1991) will be used to measure patient satisfaction with support and treatment.
Quality of life will be measured by using the EuroQol-5D (EQ-5D).
The qualitative interviews will be used to elicit information about previous attempts for help with mental health issues and questions regarding participants understanding of their postnatal depression and their future expectations from a perinatal service.
- Conditions
- Postnatal Depression, Depression, Postpartum
- Being tested
- Complex Intervention
- Keywords
- Postnatal depression, Maternal depression, Psychosocial intervention
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex InterventionBehavioural
Also called Multimodal Psychosocial Intervention
This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component and a parenting programme.
| Study group | Role | What they receive |
|---|---|---|
| Complex Intervention (LTP-TH) | Experimental | The 12 sessions of complex intervention (LTP-TH) will be delivered to mothers. Receives: Behavioral: Complex Intervention |
| Control group | No intervention | Control group will receive standard postnatal follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
We will measure change from baseline in symptoms of depression through Hamilton Depression Rating Scale (HDRS) at six months by using 17 item HDRS.
Measured: 6 months
Postnatal Depression
Edinburgh Postnatal Depression Scale (EPDS) will be used to identify mothers with postnatal depression.
Measured: 6 months
Secondary outcomes (5)
Infants' weight
Will be measured through standard anthropometric techniques and equipments
Measured: 6 months
Infants' height
Will be measured through standard anthropometric techniques and equipments
Measured: 6 months
Social Support
Social support of participants will be measured with OSLO 3-Items Social Support Scale
Measured: 6 months
health related quality of life
EuroQol-5D(EQ-5 D) will be used to measures health related quality of life in five dimensions. It provides a simple descriptive profile and a single index value for health status.
Measured: 6 months
Maternal Attachment
Maternal attachment with infants will be measured with Maternal Attachment Inventory (MAI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- Dow University of Health Sciences, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Nusrat Husain, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309516
- Sponsor's protocol ID
- pill110409
- Status last verified
- Sep 2015
- First submitted
- 22 Jan 2011
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Learning Through Play Plus Intervention to Reduce Maternal Depression for Women With Under-nourished Children: A Randomized Controlled Trial From Pakistan
- ClinicalTrials.gov ID
- NCT01309516
- Acronym / sponsor ID
- pill110409
- Conditions
- Postnatal Depression, Depression, Postpartum
- Keywords
- Postnatal depression, Maternal depression, Psychosocial intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- Dow University of Health Sciences, University of Manchester
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Mar 2011 (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 study aims to:
- Develop a culturally appropriate psychosocial intervention
- Test feasibility and acceptability of psychosocial intervention in women suffering from postnatal depression.
Primary Hypothesis:
Depressed mothers who will receive the group intervention will show significant improvements in terms of symptoms of depression.
Design:
Randomised controlled trial.
Setting:
Outpatient department of Civil hospital Karachi.
Participants:
A total of 84 depressed mothers will be randomised equally to an intervention group and a Treatment as usual control group.
Interventions:
The 12 session multimodal psychosocial intervention will be delivered to mothers in the intervention group over a three months period. Each session would take up to 45 minutes. Control group will receive standard postnatal follow-up.
Outcome measures:
Primary outcome measures would be mothers' scores on Edinburgh Postnatal Depression Scale (EPDS)and Hamilton Depression Rating Scale (HDRS).
Detailed description
A number of individual and group interventions targeting maternal depression have been developed and tested, mostly in developed countries. Group-based approaches have usually been used to improve outcomes in children through parent-training programmes. A meta-analysis of such programmes shows that these can also be effective in improving psychosocial and mental health of the mothers. However, a number of health system and cultural differences make it difficult for mental health interventions to be extrapolated from the developed to the developing world.
Design:
The interventions will be assessed using a prospective randomised controlled design, using two groups: psychosocial group therapy (Learning Through Play + principles of Cognitive Behaviour Therapy)and treatment as usual.
Defining the intervention:
The intervention will include a supportive component, an educational component, and practical advice on using health services, a parenting component, and a psychosocial component. The objective will be to help mothers feel supported, empowered and confident about their parenting abilities, which in turn may help to reduce their level of depression. Further qualitative testing of the intervention will take place to refine the manualized intervention.
Psychiatric Measures:
The level of severity of depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS) (Cox and Holden, 1994) and the Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960).
Women scoring 12 or over on the EPDS and 13 or over on the HDRS will be asked to undergo a diagnostic interview using the Clinical Interview Schedule-Revised (CIS-R).
To measure mother infant attachment the Maternal Attachment Inventory (Muller, 1994) will be used.
OSLO-3 item Social Support Scale (Dalgard, 1996) will be used to measure social support.
The adapted Verona Service Satisfaction Scale (Tansella, 1991) will be used to measure patient satisfaction with support and treatment.
Quality of life will be measured by using the EuroQol-5D (EQ-5D).
The qualitative interviews will be used to elicit information about previous attempts for help with mental health issues and questions regarding participants understanding of their postnatal depression and their future expectations from a perinatal service.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Intervention (LTP-TH) | Experimental | Behavioral: Complex InterventionThe 12 sessions of complex intervention (LTP-TH) will be delivered to mothers. |
| Control group | No intervention | –Control group will receive standard postnatal follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Depressed mothers over the age of 18 years
- Having one or more infants 6-18 months old
- Ability to give informed consent
- Resident in the study catchment area
Key exclusion criteria (1 listed)
- Women or child with diagnosed physical or learning disability and women having post-partum or other psychosis
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 |
|---|---|---|
| Complex InterventionAlso: Multimodal Psychosocial InterventionThis 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component and a parenting programme. | Behavioural | Complex Intervention (LTP-TH) |
Primary outcome
Depression
Time frame: 6 months
We will measure change from baseline in symptoms of depression through Hamilton Depression Rating Scale (HDRS) at six months by using 17 item HDRS.
Postnatal Depression
Time frame: 6 months
Edinburgh Postnatal Depression Scale (EPDS) will be used to identify mothers with postnatal depression.
5 secondary outcomes
Infants' weight
Time frame: 6 months
Infants' height
Time frame: 6 months
Social Support
Time frame: 6 months
health related quality of life
Time frame: 6 months
Maternal Attachment
Time frame: 6 months
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 22 Sep 2015.
- Pakistan Institute of Learning \& Living, Organization (Collaborator) offering logistic and technical support.Link provided by the sponsor.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Complex Intervention in people with Postnatal Depression and Depression, Postpartum, run by Pakistan Institute of Living and Learning at 2 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 1 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 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Depression (time frame: 6 months). The study lists 2 primary outcomes in all. 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 22 Sep 2015.