Interpersonal Psychotherapy for Maternal Depression

Maternal Depression Clinical Trial

Official title:

Randomized Control Trial of an Interpersonal Psychotherapy for Maternal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310529
• Other study ID #: PILL-IPT
• Status: Completed
• Phase: N/A
• First received: November 15, 2014
• Last updated: August 15, 2015
• Start date: March 2014
• Est. completion date: January 2015

Study information

• Verified date: August 2015
• Source: Pakistan Institute of Learning and Living
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Pakistan Institute of Learning and Living
• Study type: Interventional

Clinical 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). 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Maternal Depression

Intervention

Behavioral:
• Interpersonal Psychotherapy
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.

Locations

Country	Name	City	State
Pakistan	Bhitaiabad	Karachi	Sind
Pakistan	Bilal Colony	Karachi	Sindh
Pakistan	Civil hospital Karachi	Karachi	Sindh
Pakistan	Yousuf Goth	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Learning and Living

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient Health Questionnaire-9 (PHQ-9)	PHQ-9 will be used to assess severity of depression	3 and 6 Months	No
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	GAD-7 will be used to assess severity of anxiety	3 and 6 Months	No
Secondary	Rosenberg Self Esteem Scale (RSES)	This scale will ne used to assess self esteem	3 and 6 Months	No

External Links

•   Organizational Website