Maternal DepressionTLMCNCT03430622
Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT)
A study testing LTP Plus and TAU in people with Maternal Depression, run by Pakistan Institute of Living and Learning at 6 sites in Pakistan.
Trial summary
To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal depression. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Maternal Depression
- What is being tested?
- LTP Plus and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 6 sitesPakistan
- Study dates
- 20 Feb 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Pakistan6 sites
Pediatric units
Hyderābād, Sindh
Pediatric units
Karachi, Sindh
Pedratric units
Lahore, Punjab Province
Pediatric units
Nawabshah, Sindh
Pediatric units
Peshawar, Sindh
Pediatric units
Quetta, Balochistan
About this study
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
To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal depression.
Read the 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.
- Conditions
- Maternal Depression
- Being tested
- LTP Plus, TAU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTP PlusBehavioural
Also called Psycho-social Intervention
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.
TAUOther
Also called Treatment as Usual
This group will be on their routine care and will not be given any intervention
| Study group | Role | What they receive |
|---|---|---|
| LTP Plus | Experimental | 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. Receives: Behavioral: LTP Plus |
| Treatment as Usual (TAU) | Active comparator | 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. Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Clinical Interview for DSM-IV (SCID)
The primary outcome is depression which will be measured using Structured Clinical Interview for DSM-V Disorders (SCID)
Measured: Time Frame: Changes from baseline to 6th month after randomization ]
Secondary outcomes (12)
Generalized Anxiety Disorder (GAD) 7
The GAD-7 is a 7 item scale will be used to screen for and measure severity of Generalized Anxiety Disorder
Measured: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
The Postpartum Bonding Questionnaire (PBQ)
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'.
Measured: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
Experiences in Close Relationships-Revised (ECR-R)
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.
Measured: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
Dyadic Adjustment Scale, (DAS)
DAS is a 32 items self-report questionnaire, to measure couple satisfaction and to assess how each partner perceives his/her relationship.
Measured: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
Client Service Receipt Inventory
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.
Measured: [Time Frame: Changes from baseline to 3rd month]
Infant development: Infant development:
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.
Measured: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
Ages and Stages Social-Emotional Questionnaire
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.
Measured: Changes from baseline to 3rd month and 6th month after randomization]
World Health Organisation Quality of Life (WHO, 2004)
A self-report scale comprising of 26 items which measures physical health, psychological health, social relationships and environment.
Measured: Changes from baseline to 3rd month and 6th month after randomization]
Learning Through Play (LTP) KAP Questionnaire
This scale will be used to measure change in Knowledge, Attitude and Practices (KAP) at different time points.
Measured: Changes from baseline to 3rd month and 6th month after randomization]
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.
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.
Measured: Time Frame: Changes from baseline to 3rd month and 6th month after randomization ]
Client Satisfaction Questionnaire
The participants will rate their satisfaction with treatment after completion of intervention. Higher score indicate greater satisfaction
Measured: Time Frame: Score at 3rd month assessment only.
How are you feeling scale
This is a pictorial scale to assess mood disturbance. higher score indicate greater severity of depression.
Measured: Time Frame: Changes from baseline to 3rd month and 6th month after randomization ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start20 Feb 2018
- Primary completion20 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Chaudhry, Principal investigator, Pakistan Institute of Living & Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430622
- Sponsor's protocol ID
- PILL-Telemothercare01
- Acronym
- TLMC
- Status last verified
- Jul 2021
- First submitted
- 6 Feb 2018
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03430622
- Acronym / sponsor ID
- TLMC / PILL-Telemothercare01
- Conditions
- Maternal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTP Plus | Experimental | Behavioral: LTP PlusLTP 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 as Usual (TAU) | Active comparator | Other: TAUTAU group will receive routine care and their follow up will be done after completion of the intervention and then at 6-month post randomization. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTP PlusAlso: Psycho-social InterventionLTP 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. | Behavioural | LTP Plus |
| TAUAlso: Treatment as UsualThis group will be on their routine care and will not be given any intervention | Other | Treatment as Usual (TAU) |
Primary outcome
Structured Clinical Interview for DSM-IV (SCID)
Time frame: Time Frame: Changes from baseline to 6th month after randomization ]
The primary outcome is depression which will be measured using Structured Clinical Interview for DSM-V Disorders (SCID)
12 secondary outcomes
Generalized Anxiety Disorder (GAD) 7
Time frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
The Postpartum Bonding Questionnaire (PBQ)
Time frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
Experiences in Close Relationships-Revised (ECR-R)
Time frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
Dyadic Adjustment Scale, (DAS)
Time frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
Client Service Receipt Inventory
Time frame: [Time Frame: Changes from baseline to 3rd month]
Infant development: Infant development:
Time frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
Ages and Stages Social-Emotional Questionnaire
Time frame: Changes from baseline to 3rd month and 6th month after randomization]
World Health Organisation Quality of Life (WHO, 2004)
Time frame: Changes from baseline to 3rd month and 6th month after randomization]
Learning Through Play (LTP) KAP Questionnaire
Time frame: Changes from baseline to 3rd month and 6th month after randomization]
Patient Health Questionnaire (PHQ-9)
Time frame: Time Frame: Changes from baseline to 3rd month and 6th month after randomization ]
Client Satisfaction Questionnaire
Time frame: Time Frame: Score at 3rd month assessment only.
How are you feeling scale
Time frame: Time Frame: Changes from baseline to 3rd month and 6th month after randomization ]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasim Chaudhry principal investigator
Pakistan Institute of Living & Learning
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTP Plus and TAU in people with Maternal Depression, run by Pakistan Institute of Living and Learning at 6 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Clinical Interview for DSM-IV (SCID) (time frame: Time Frame: Changes from baseline to 6th month after randomization ]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.