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Interpersonal Psychotherapy for Maternal Depression

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ClinicalTrials.gov Identifier: NCT02310529
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

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.


Condition or disease Intervention/treatment Phase
Maternal Depression Behavioral: Interpersonal Psychotherapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of an Interpersonal Psychotherapy for Maternal Depression
Study Start Date : March 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Other Name: IPT

No Intervention: Treatment as usual
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).



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 3 and 6 Months ]
    PHQ-9 will be used to assess severity of depression

  2. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 3 and 6 Months ]
    GAD-7 will be used to assess severity of anxiety

  3. Rosenberg Self Esteem Scale (RSES) [ Time Frame: 3 and 6 Months ]
    This scale will ne used to assess self esteem



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310529


Locations
Pakistan
Civil hospital Karachi
Karachi, Sindh, Pakistan, 72000
Bilal Colony
Karachi, Sindh, Pakistan
Yousuf Goth
Karachi, Sindh, Pakistan
Bhitaiabad
Karachi, Sind, Pakistan
Sponsors and Collaborators
Pakistan Institute of Living and Learning
Investigators
Study Director: Dr. Nusrat Husain PILL

Additional Information:
Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT02310529     History of Changes
Other Study ID Numbers: PILL-IPT
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015

Keywords provided by Pakistan Institute of Living and Learning:
Maternal depression
Interpersonal Psycotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders