Clinical trial NCT03430622: Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT)
Official title: Telephone Delivered Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT) for Depressed Mothers - A Multicentre Randomized Controlled Trial (RCT) in a Low-Income Country
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 370
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal depression.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Participants will be included in the study if they are:

18 to 44 years old mothers with children aged between 0-30 months having a diagnosis of major depressive disorder using the Structure Clinical Interview for DSM-V, Ability to complete a baseline assessment, Participating mother having telephone/mobile phone access for at least one hour per week.

Exclusion Criteria:

Participants will be excluded from the study if they have:

Any medical illness that will prevent them from participation in the clinical trial, current or past diagnosis of bipolar depression, currently using antidepressants or receiving any kind of psychotherapy, active suicidal ideation, any other severe physical or mental disorder, no access to telephone/mobile.

Primary outcomes:
measure: Structured Clinical Interview for DSM-IV (SCID)
timeFrame: Time Frame: Changes from baseline to 6th month after randomization ]
Secondary outcomes:
measure: Generalized Anxiety Disorder (GAD) 7
timeFrame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
measure: The Postpartum Bonding Questionnaire (PBQ)
timeFrame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
measure: Experiences in Close Relationships-Revised (ECR-R)
timeFrame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
measure: Dyadic Adjustment Scale, (DAS)
timeFrame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
measure: Client Service Receipt Inventory
timeFrame: [Time Frame: Changes from baseline to 3rd month]
measure: Infant development: Infant development:
timeFrame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
measure: Ages and Stages Social-Emotional Questionnaire
timeFrame: Changes from baseline to 3rd month and 6th month after randomization]
measure: World Health Organisation Quality of Life (WHO, 2004)
timeFrame: Changes from baseline to 3rd month and 6th month after randomization]
measure: Learning Through Play (LTP) KAP Questionnaire
timeFrame: Changes from baseline to 3rd month and 6th month after randomization]
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Time Frame: Changes from baseline to 3rd month and 6th month after randomization ]
measure: Client Satisfaction Questionnaire
timeFrame: Time Frame: Score at 3rd month assessment only.
measure: How are you feeling scale
timeFrame: Time Frame: Changes from baseline to 3rd month and 6th month after randomization ]
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Pediatric units
state: Balochistan
city: Lahore
country: Pakistan
facility: Pedratric units
state: Punjab
city: Hyderabad
country: Pakistan
facility: Pediatric units
state: Sindh
city: Karachi
country: Pakistan
facility: Pediatric units
state: Sindh
city: Nawabshah
country: Pakistan
facility: Pediatric units
state: Sindh
city: Peshawar
country: Pakistan
facility: Pediatric units
state: Sindh
Study officials:
affiliation: Pakistan Institute of Living & Learning
name: Nasim Chaudhry
role: PRINCIPAL_INVESTIGATOR
References: