Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT) (TLMC)

Pakistan Institute of Living and Learning

Status: Completed

Conditions: Maternal Depression

Treatments: Other: TAU; Behavioral: LTP Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT03430622

PILL-Telemothercare01

Details and patient eligibility

About

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

Full 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.

Enrollment: 370 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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370 participants in 2 patient groups

LTP Plus

Experimental group

Description:

LTP Plus group participants will receive intervention over the telephone for 3 months one session per week for 2 months and rest of the sessions fortnightly by trained graduates, expert in delivering LTP plus intervention.

Treatment:

Behavioral: LTP Plus

Treatment as Usual (TAU)

Active Comparator group

Description:

TAU group will receive routine care and their follow up will be done after completion of the intervention and then at 6-month post randomization.

Treatment:

Other: TAU