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Interpersonal Psychotherapy for Maternal Depression

Primary Purpose

Maternal Depression

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Interpersonal Psychotherapy
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Depression focused on measuring Maternal depression, Interpersonal Psycotherapy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Civil hospital Karachi
  • Bilal Colony
  • Yousuf Goth
  • Bhitaiabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interpersonal Psychotherapy

Treatment as usual

Arm Description

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 Groups will assist people who have become withdrawn, isolated and disconnected.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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 will be used to assess severity of depression
Generalized Anxiety Disorder-7 (GAD-7)
GAD-7 will be used to assess severity of anxiety
Rosenberg Self Esteem Scale (RSES)
This scale will ne used to assess self esteem

Full Information

First Posted
November 15, 2014
Last Updated
August 15, 2015
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT02310529
Brief Title
Interpersonal Psychotherapy for Maternal Depression
Official Title
Randomized Control Trial of an Interpersonal Psychotherapy for Maternal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression
Keywords
Maternal depression, Interpersonal Psycotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal Psychotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Other Intervention Name(s)
IPT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Edinberg Postnatal Depression Scale (EPDS) To test the feasibility and acceptability of interpersonal psychotherapy in women suffering from postnatal depression.
Description
EPDS will be used to assess depression
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
PHQ-9 will be used to assess severity of depression
Time Frame
3 and 6 Months
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
GAD-7 will be used to assess severity of anxiety
Time Frame
3 and 6 Months
Title
Rosenberg Self Esteem Scale (RSES)
Description
This scale will ne used to assess self esteem
Time Frame
3 and 6 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Nusrat Husain
Organizational Affiliation
PILL
Official's Role
Study Director
Facility Information:
Facility Name
Civil hospital Karachi
City
Karachi
State/Province
Sindh
ZIP/Postal Code
72000
Country
Pakistan
Facility Name
Bilal Colony
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Yousuf Goth
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Bhitaiabad
City
Karachi
State/Province
Sind
Country
Pakistan

12. IPD Sharing Statement

Links:
URL
http://pill.org.pk
Description
Organizational Website

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Interpersonal Psychotherapy for Maternal Depression

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