Maternal DepressionNCT02310529
Interpersonal Psychotherapy for Maternal Depression
A study testing Interpersonal Psychotherapy in people with Maternal Depression, run by Pakistan Institute of Living and Learning at 4 sites in Pakistan.
Trial summary
Depression related to pregnancy frequently presents postpartum depression, which has deteriorating and lasting negative effects, not only on infant and child well being but also on mother's and father's mental health (Nancy K et al 2009). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Maternal Depression
- What is being tested?
- Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesPakistan
- Study dates
- Mar 2014to Jan 2015
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mothers age 18 years and above older with child below 3 years of age
- Meet the criteria for mild to moderate depressive symptoms on (EPDS (cut off score above 10) and
- Were resident of trial catchment area were included in the study.
Who cannot join
- Mothers who were suffering from severe depression, with diagnosed learning or physical disability or
- Any major psychiatric illness other than maternal depression, with Alcohol and substance dependent or
- Actively suicidal were excluded from the study.
Trial locations and contacts
4 sites in 1 country.
Pakistan4 sites
Civil hospital Karachi
Karachi, Sindh, 72000
Bhitaiabad
Karachi, Sindh
Bilal Colony
Karachi, Sindh
Yousuf Goth
Karachi, Sindh
About this study
Official title: Randomized Control Trial of an Interpersonal Psychotherapy for Maternal Depression
Depression related to pregnancy frequently presents postpartum depression, which has deteriorating and lasting negative effects, not only on infant and child well being but also on mother's and father's mental health (Nancy K et al 2009). It is therefore important to introduce interventions aiming to improve mental health of mothers that could minimize the risk of diseases, and have positive effect child's on physical and psychological developmental wellbeing.
Therefore, this project has been designed to assess the effectiveness of Interpersonal Psychotherapy for Postnatal Depression in Pakistan.
Read the detailed description
Prevalence of depression in the postnatal period is 10% to 17 % in western world ( O 'Hara and Swain 1996; Josseffson et al 2001; Yoshida et al 2001) and 23% to 36% in the developing world (Rahman et al 2003; Patel et al 2002; Husain et al 2006).
In developed countries, studies indicate that maternal depression is associated with long-term emotional, cognitive and behavioral problem in children. There is evidence of link between maternal psychopathology to physical health of child. Research evidence also indicates that long-term negative impact of postnatal depression is on the mother's mental health, on infant's development and on the marital relationship (Reay, Fisher, Robertson, Adams and Owen 2005).
because of high prevalence of maternal depression in low income countries like Pakistan, the present study is designed to test the effectiveness of Interpersonal Psychotherapy for women with maternal depression. The participants will be recruited from Civil hospital Karachi and also from three different communities. total 50 participants will be recruited and randomized to 2 groups: either intervention or TAU group. Assessment will be done on baseline, after completion of intervention and 3 months after completion of intervention. Assessment will include Edinburg Postnatal depression scale, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Rosenberg Self Esteem scale. Participants in intervention group will receive 12 sessions of Interpersonal Psychotherapy (IPT)
- Conditions
- Maternal Depression
- Being tested
- Interpersonal Psychotherapy
- Keywords
- Maternal depression, Interpersonal Psycotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal PsychotherapyBehavioural
Also called IPT
Interpersonal Psychotherapy will be delivered to Intervention group. The intervention group will be further divided into 3 groups (8 depressed mothers in each group).IPT is 12-16 week treatment, contains a supportive element, an educational element, parenting element and an interpersonal relationship element. Its goals include helping mothers feel supportive, empowered and confident about their parenting abilities, which will directly influence in reducing their depressive symptoms as well as resolution of interpersonal conflicts. Groups will assist people who have become withdrawn, isolated and disconnected.
Intervention will be delivered by trained clinical psychologists.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Interpersonal Psychotherapy will be delivered to Intervention group. The intervention group will be further divided into 3 groups (8 depressed mothers in each group). IPT is 12-16 week treatment, contains a supportive element, an educational element, parenting element and an interpersonal relationship element. Its goals include helping mothers feel supportive, empowered and confident about their parenting abilities, which will directly influence in reducing their depressive symptoms as well as resolution of interpersonal conflicts. Groups will assist people who have become withdrawn, isolated and disconnected. Intervention will be delivered by trained clinical psychologists. Receives: Behavioral: Interpersonal Psychotherapy |
| Treatment as usual | No intervention | Patients including in this group will be taking only treatment as usual (in Pakistan it means that participants attending in outpatients' clinic at regular intervals and may or may not be taking prescribed medication). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinberg Postnatal Depression Scale (EPDS) To test the feasibility and acceptability of interpersonal psychotherapy in women suffering from postnatal depression.
EPDS will be used to assess depression
Measured: 3 months
Secondary outcomes (3)
Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 will be used to assess severity of depression
Measured: 3 and 6 Months
Generalized Anxiety Disorder-7 (GAD-7)
GAD-7 will be used to assess severity of anxiety
Measured: 3 and 6 Months
Rosenberg Self Esteem Scale (RSES)
This scale will ne used to assess self esteem
Measured: 3 and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Nusrat Husain, Study director, PILL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310529
- Sponsor's protocol ID
- PILL-IPT
- Status last verified
- Aug 2015
- First submitted
- 15 Nov 2014
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of an Interpersonal Psychotherapy for Maternal Depression
- ClinicalTrials.gov ID
- NCT02310529
- Acronym / sponsor ID
- PILL-IPT
- Conditions
- Maternal Depression
- Keywords
- Maternal depression, Interpersonal Psycotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Dec 2014 (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.
Depression related to pregnancy frequently presents postpartum depression, which has deteriorating and lasting negative effects, not only on infant and child well being but also on mother's and father's mental health (Nancy K et al 2009). It is therefore important to introduce interventions aiming to improve mental health of mothers that could minimize the risk of diseases, and have positive effect child's on physical and psychological developmental wellbeing.
Therefore, this project has been designed to assess the effectiveness of Interpersonal Psychotherapy for Postnatal Depression in Pakistan.
Detailed description
Prevalence of depression in the postnatal period is 10% to 17 % in western world ( O 'Hara and Swain 1996; Josseffson et al 2001; Yoshida et al 2001) and 23% to 36% in the developing world (Rahman et al 2003; Patel et al 2002; Husain et al 2006).
In developed countries, studies indicate that maternal depression is associated with long-term emotional, cognitive and behavioral problem in children. There is evidence of link between maternal psychopathology to physical health of child. Research evidence also indicates that long-term negative impact of postnatal depression is on the mother's mental health, on infant's development and on the marital relationship (Reay, Fisher, Robertson, Adams and Owen 2005).
because of high prevalence of maternal depression in low income countries like Pakistan, the present study is designed to test the effectiveness of Interpersonal Psychotherapy for women with maternal depression. The participants will be recruited from Civil hospital Karachi and also from three different communities. total 50 participants will be recruited and randomized to 2 groups: either intervention or TAU group. Assessment will be done on baseline, after completion of intervention and 3 months after completion of intervention. Assessment will include Edinburg Postnatal depression scale, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Rosenberg Self Esteem scale. Participants in intervention group will receive 12 sessions of Interpersonal Psychotherapy (IPT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Behavioral: Interpersonal PsychotherapyInterpersonal Psychotherapy will be delivered to Intervention group. The intervention group will be further divided into 3 groups (8 depressed mothers in each group). IPT is 12-16 week treatment, contains a supportive element, an educational element, parenting element and an interpersonal relationship element. Its goals include helping mothers feel supportive, empowered and confident about their parenting abilities, which will directly influence in reducing their depressive symptoms as well as resolution of interpersonal conflicts. Groups will assist people who have become withdrawn, isolated and disconnected. Intervention will be delivered by trained clinical psychologists. |
| Treatment as usual | No intervention | –Patients including in this group will be taking only treatment as usual (in Pakistan it means that participants attending in outpatients' clinic at regular intervals and may or may not be taking prescribed medication). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mothers age 18 years and above older with child below 3 years of age
- Meet the criteria for mild to moderate depressive symptoms on (EPDS (cut off score above 10) and
- Were resident of trial catchment area were included in the study.
Key exclusion criteria (3 listed)
- Mothers who were suffering from severe depression, with diagnosed learning or physical disability or
- Any major psychiatric illness other than maternal depression, with Alcohol and substance dependent or
- Actively suicidal were excluded from the study.
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 |
|---|---|---|
| Interpersonal PsychotherapyAlso: IPTInterpersonal Psychotherapy will be delivered to Intervention group. The intervention group will be further divided into 3 groups (8 depressed mothers in each group).IPT is 12-16 week treatment, contains a supportive element, an educational element, parenting element and an interpersonal relationship element. Its goals include helping mothers feel supportive, empowered and confident about their parenting abilities, which will directly influence in reducing their depressive symptoms as well as resolution of interpersonal conflicts. Groups will assist people who have become withdrawn, isolated and disconnected. Intervention will be delivered by trained clinical psychologists. | Behavioural | Interpersonal Psychotherapy |
Primary outcome
Edinberg Postnatal Depression Scale (EPDS) To test the feasibility and acceptability of interpersonal psychotherapy in women suffering from postnatal depression.
Time frame: 3 months
EPDS will be used to assess depression
3 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 and 6 Months
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 3 and 6 Months
Rosenberg Self Esteem Scale (RSES)
Time frame: 3 and 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 18 Aug 2015.
- Organizational WebsiteLink provided by the sponsor.
Related trials for Maternal Depression
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Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
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Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Recruiting
Methyl Donor-Rich Diet in the Postpartum Period
Postpartum Depression (PPD), Breastfeeding
Active, not recruiting
Improving Maternal Mental Health & SUD Screening and Treatment
Mental Health Issue, Substance Use Disorders
Recruiting
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
Postpartum Depression, Postpartum Anxiety
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.
Dr. Nusrat Husain study director
PILL
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy in people with Maternal Depression, run by Pakistan Institute of Living and Learning at 4 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 3 inclusion and 3 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 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Edinberg Postnatal Depression Scale (EPDS) To test the feasibility and acceptability of interpersonal psychotherapy in women suffering from postnatal depression. (time frame: 3 months). 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 18 Aug 2015.