Telephone Delivered Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT) for Depressed Mothers - A Multicentre Randomized Controlled Trial (RCT) in a Low-Income Country
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 6
- 主要终点
- Structured Clinical Interview for DSM-IV (SCID)
研究概览
简要总结
To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal depression.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Researchers doing outcome assessment will be kept blind to the group allocations
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: TAU (Other)
结局指标
主要结局
Structured Clinical Interview for DSM-IV (SCID)
时间窗: 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)
次要结局
- Generalized Anxiety Disorder (GAD) 7([Time Frame: Changes from baseline to 3rd month and 6th month after randomization])
- The Postpartum Bonding Questionnaire (PBQ)([Time Frame: Changes from baseline to 3rd month and 6th month after randomization])
- Experiences in Close Relationships-Revised (ECR-R)([Time Frame: Changes from baseline to 3rd month and 6th month after randomization])
- Dyadic Adjustment Scale, (DAS)([Time Frame: Changes from baseline to 3rd month and 6th month after randomization])
- Client Service Receipt Inventory([Time Frame: Changes from baseline to 3rd month])
- Infant development: Infant development:([Time Frame: Changes from baseline to 3rd month and 6th month after randomization])
- Ages and Stages Social-Emotional Questionnaire(Changes from baseline to 3rd month and 6th month after randomization])
- World Health Organisation Quality of Life (WHO, 2004)(Changes from baseline to 3rd month and 6th month after randomization])
- Learning Through Play (LTP) KAP Questionnaire(Changes from baseline to 3rd month and 6th month after randomization])
- Patient Health Questionnaire (PHQ-9)(Time Frame: Changes from baseline to 3rd month and 6th month after randomization ])
- Client Satisfaction Questionnaire(Time Frame: Score at 3rd month assessment only.)
- How are you feeling scale(Time Frame: Changes from baseline to 3rd month and 6th month after randomization ])