Randomised Control Trial of a Complex Intervention for Postnatal Depression

September 19, 2015 updated by: Pakistan Institute of Living and Learning

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:

  1. Develop a culturally appropriate psychosocial intervention
  2. 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75600
        • Civil Hospital
      • Karachi, Sindh, Pakistan
        • Abbasi Shaheed hospital Karachi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Women or child with diagnosed physical or learning disability and women having post-partum or other psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Complex Intervention (LTP-TH)
The 12 sessions of complex intervention (LTP-TH) will be delivered to mothers.
Behavioral: Complex Intervention
This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component and a parenting programme.
Other Names:
  • Multimodal Psychosocial Intervention
NO_INTERVENTION: Control group
Control group will receive standard postnatal follow-up.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
Postnatal Depression
Time Frame: 6 months
Edinburgh Postnatal Depression Scale (EPDS) will be used to identify mothers with postnatal depression.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infants' weight
Time Frame: 6 months
Will be measured through standard anthropometric techniques and equipments
6 months
Infants' height
Time Frame: 6 months
Will be measured through standard anthropometric techniques and equipments
6 months
Social Support
Time Frame: 6 months
Social support of participants will be measured with OSLO 3-Items Social Support Scale
6 months
health related quality of life
Time Frame: 6 months
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.
6 months
Maternal Attachment
Time Frame: 6 months
Maternal attachment with infants will be measured with Maternal Attachment Inventory (MAI)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pakistan Institute of Living and Learning

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Manchester
Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pill110409

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