NCT02310529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

10 months

First QC Date

November 15, 2014

Last Update Submit

August 15, 2015

Conditions

Maternal Depression

Keywords

Maternal depressionInterpersonal Psycotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (3)

  • Patient Health Questionnaire-9 (PHQ-9)

    3 and 6 Months

  • Generalized Anxiety Disorder-7 (GAD-7)

    3 and 6 Months

  • Rosenberg Self Esteem Scale (RSES)

    3 and 6 Months

Study Arms (2)

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.

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).

Interventions

Interpersonal PsychotherapyBEHAVIORAL

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.

Also known as: IPT
Interpersonal Psychotherapy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Civil hospital Karachi

Karachi, Sindh, 72000, Pakistan

Location

Bhitaiabad

Karachi, Sindh, Pakistan

Location

Bilal Colony

Karachi, Sindh, Pakistan

Location

Yousuf Goth

Karachi, Sindh, Pakistan

Location

Related Links

MeSH Terms

Interventions

Interpersonal Psychotherapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dr. Nusrat Husain

    PILL

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2014

First Posted

December 8, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

PA(4)