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Interpersonal Psychotherapy for Maternal Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 15, 2014
First Posted Date  ICMJE December 8, 2014
Last Update Posted Date August 18, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 3 and 6 Months ]
    PHQ-9 will be used to assess severity of depression
  • Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 3 and 6 Months ]
    GAD-7 will be used to assess severity of anxiety
  • Rosenberg Self Esteem Scale (RSES) [ Time Frame: 3 and 6 Months ]
    This scale will ne used to assess self esteem
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interpersonal Psychotherapy for Maternal Depression
Official Title  ICMJE Randomized Control Trial of an Interpersonal Psychotherapy for Maternal Depression
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Maternal Depression
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Interpersonal Psychotherapy
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02310529
Other Study ID Numbers  ICMJE PILL-IPT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pakistan Institute of Living and Learning
Study Sponsor  ICMJE Pakistan Institute of Living and Learning
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dr. Nusrat Husain PILL
PRS Account Pakistan Institute of Living and Learning
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP