Clinical trial NCT02310529: Interpersonal Psychotherapy for Maternal Depression
Official title: Randomized Control Trial of an Interpersonal Psychotherapy for Maternal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Keywords: Maternal depression
Interpersonal Psycotherapy
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Edinberg Postnatal Depression Scale (EPDS) To test the feasibility and acceptability of interpersonal psychotherapy in women suffering from postnatal depression.
timeFrame: 3 months
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 and 6 Months
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 3 and 6 Months
measure: Rosenberg Self Esteem Scale (RSES)
timeFrame: 3 and 6 Months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Civil hospital Karachi
state: Sindh
city: Karachi
country: Pakistan
facility: Bilal Colony
state: Sindh
city: Karachi
country: Pakistan
facility: Yousuf Goth
state: Sindh
city: Karachi
country: Pakistan
facility: Bhitaiabad
state: Sind
Study officials:
affiliation: PILL
name: Dr. Nusrat Husain
role: STUDY_DIRECTOR
References: