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Telephone Delivered Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT) for Depressed Mothers - A Multicentre Randomized Controlled Trial (RCT) in a Low-Income Country
To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal depression.
Despite the high prevalence of maternal depression in Pakistan, research on psychosocial interventions is limited. We will test the effectiveness of a telephone based intervention program called Learning through Play plus Interpersonal Psychotherapy (LTP Plus) that can be used by non-specialists, including trained graduates, mothers and lay health workers with minimal training. This telephone communication will be supplemented by the provision of LTP Plus pictorial calendars to the depressed mothers. Purpose of this RCT is to determine if telephone delivered intervention of the LTP plus programme reduces symptoms of maternal depression and improves infant development compared to Treatment as usual. A sample of 354 (177 in each group) will be required. The study will be conducted in big cities of Pakistan including Karachi, Lahore, Hyderabad, Nawabshah, Quetta and Peshawar.Participants will be screened using Patient Health Questionnaire (PHQ-9) and eligibility checklist. Those scoring 10 and above on PHQ-9 will be invited to participate in the study. Assessments will be done at baseline and after completion of intervention (3rd month and 6th month after randomization). All follow ups will be done by independent Research Assistants (RAs), blind to the treatment allocations.
Age
18 - 44 years
Sex
FEMALE
Healthy Volunteers
No
Pediatric units
Quetta, Balochistan, Pakistan
Pedratric units
Lahore, Punjab Province, Pakistan
Pediatric units
Hyderābād, Sindh, Pakistan
Pediatric units
Karachi, Sindh, Pakistan
Pediatric units
Nawabshah, Sindh, Pakistan
Pediatric units
Peshawar, Sindh, Pakistan
Start Date
February 20, 2018
Primary Completion Date
August 20, 2019
Completion Date
August 30, 2019
Last Updated
July 13, 2021
370
ACTUAL participants
LTP Plus
BEHAVIORAL
TAU
OTHER
Lead Sponsor
Pakistan Institute of Living and Learning
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT02310529