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Trial record 9 of 17 for:    Postpartum Depression AND Interpersonal Psychotherapy | "Depression" AND "Depression"

Effectiveness of a Telephone Based Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT) for Depressed Mothers (Telemothercare)

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ClinicalTrials.gov Identifier: NCT03430622
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

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

Condition or disease Intervention/treatment Phase
Postnatal Depression Behavioral: LTP Plus Other: TAU Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Researchers doing outcome assessment will be kept blind to the group allocations
Primary Purpose: Treatment
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
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LTP Plus
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.
Behavioral: LTP Plus
LTP Plus is comprised of two components; Learning through play (LTP) and Interpersonal Psychotherapy (IPT). The LTP Plus is a low-literacy; sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Interpersonal Psychotherapy (IPT) intervention is comprised of a supportive element, an educational element, a parenting element and an interpersonal relationship element. Intervention goals include helping mothers feel supported, empowered and confident about their parenting abilities, which would directly influence reduction in depressive symptoms as well as resolution of interpersonal conflicts.
Other Name: Psycho-social Intervention

Active Comparator: Treatment as Usual (TAU)
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.
Other: TAU
This group will be on their routine care and will not be given any intervention
Other Name: Treatment as Usual




Primary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: Time Frame: Changes from baseline to 3rd month and 6th month after randomization ] ]

    The Patient health Questionnaire (PHQ-9) is 9 items self-report questionnaire. A score of 10 or above is taken as cut -off point for depressive disorder. This scale will be used to check severity of depression.

    Patient Health Questionnaire (PHQ-9) The Patient health Questionnaire (PHQ-9) is 9 items self-report questionnaire. A score of 10 or above is taken as cut -off point for depressive disorder. This scale will be used to check severity of depression.



Secondary Outcome Measures :
  1. Generalized Anxiety Disorder (GAD) 7 [ Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization] ]
    The GAD-7 is a 7 item scale will be used to screen for and measure severity of Generalized Anxiety Disorder

  2. The Postpartum Bonding Questionnaire (PBQ) [ Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization] ]
    The PBQ is designed to detect disturbance in the mother-child relationship. The scale has 25 items, each followed by six alternative responses ranging from 'always' to 'never'.

  3. Experiences in Close Relationships-Revised (ECR-R) [ Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization] ]
    The ECR-R measures individuals on two subscales of attachment: Avoidance and Anxiety. In general avoidant individuals find discomfort with intimacy and seek independence, whereas anxious individuals tend to fear rejection and abandonment.

  4. Dyadic Adjustment Scale, (DAS) [ Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization] ]
    DAS is a 32 items self-report questionnaire, to measure couple satisfaction and to assess how each partner perceives his/her relationship.

  5. Client Service Receipt Inventory [ Time Frame: [Time Frame: Changes from baseline to 3rd month] ]
    We will collect information about the use of other health services (including the informal sector, faith healers/Imams) using CSRI based on our previous work in Pakistan.

  6. Infant development: Infant development: [ Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization] ]
    Ages and Stages Questionnaire will be used to measure child development. Parents will report on their child's communication, gross and fine motor skills, problem solving and personal-social development at different time points.

  7. Ages and Stages Social-Emotional Questionnaire [ Time Frame: Changes from baseline to 3rd month and 6th month after randomization] ]
    Ages and Stages will be used to obtain maternal report on their child's social and emotional development. The questionnaire is already translated in Urdu and will be used in the proposed trial.

  8. World Health Organisation Quality of Life (WHO, 2004) [ Time Frame: Changes from baseline to 3rd month and 6th month after randomization] ]
    A self-report scale comprising of 26 items which measures physical health, psychological health, social relationships and environment.

  9. Learning Through Play (LTP) KAP Questionnaire [ Time Frame: Changes from baseline to 3rd month and 6th month after randomization] ]
    This scale will be used to measure change in Knowledge, Attitude and Practices (KAP) at different time points.



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


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): NCT03430622


Contacts
Contact: Nasim Chaudhry, (MRC Psych, FRC Psych, MD) 02135871845 nasim.chaudhry@pill.org.pk
Contact: Rabia Sattar, MPhil 03332976807 rabia.sattar@pill.org.pk

Locations
Pakistan
Pediatric units Not yet recruiting
Quetta, Balochistan, Pakistan
Pedratric units Not yet recruiting
Lahore, Punjab, Pakistan
Pediatric units Recruiting
Hyderabad, Sindh, Pakistan
Pediatric units Recruiting
Karachi, Sindh, Pakistan
Pediatric units Not yet recruiting
Nawabshah, Sindh, Pakistan
Pediatric units Not yet recruiting
Peshawar, Sindh, Pakistan
Sponsors and Collaborators
Pakistan Institute of Living and Learning
Investigators
Principal Investigator: Nasim Chaudhry Pakistan Institute of Living & Learning

Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT03430622     History of Changes
Other Study ID Numbers: PILL-Telemothercare01
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders