The Effectiveness of Cognitive Behavioral Therapy in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Improvement in anxiety score
研究概览
简要总结
The goal of this clinical trial is to learn if Cognitive Behavioral Therapy (CBT) can improve psychological, neurological, and hormonal aspects in women undergoing In Vitro Fertilization (IVF). The main questions it aims to answer are:
- Is CBT effective in improving psychological aspects (anxiety, depression, and coping mechanism) in women undergoing IVF?
- Is CBT effective in improving neuroendocrine aspects (cortisol levels, neuroepinephrine levels, free trioodothyronine levels) in women underoing IVF?
Researchers will compare CBT to no intervention to see if CBT is effective in improving psychoneuroendocrine aspects.
详细描述
Participants will
- attend 8 appointments once a week, during which they will be given CBT or no intervention
- have their anxiety score, depression score, and dominant coping mechanism assessed before the first appointment and during appointment 3, 6, and 8
- have their cortisol levels, norepinephrine levels, and free triiodothyronine levels assessed before the first appointment and during appointment 3, 6, and 8
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with primary infertility
- •Aged 25-42 at the start of the study
- •Willing to participate in the study and willing to sign informed consent form
- •Minimum education of high school, able to read, write and understand Bahasa Indonesia
排除标准
- •Having one or multiple psychotic disorder(s)
结局指标
主要结局
Improvement in anxiety score
时间窗: Baseline (1 month before IVF program begins/1 week before pre-IVF counselling begins), interim assessments (at the start of IVF program, at 3 weeks of IVF program, and at 5 weeks of IVF program).
Hamilton Anxiety Rating Scale (HAM-A), Indonesian version, with minimum score of 0 and maximum score of 56. A score of 0-7 indicates no or minimum anxiety; a score of 8-14 indicates mild anxiety; a score of 15-23 indicates moderate anxiety; and a score of 24 and more indicates severe anxiety. Lower score indicates a better outcome.
Improvement in cortisol levels
时间窗: Baseline (1 month before IVF program begins/1 week before pre-IVF counselling begins), interim assessments (at the start of IVF program, at 3 weeks of IVF program, and at 5 weeks of IVF program).
Blood samples are taken from the participants, of which Hormonal Assay test is then performed. 10-20 µg/dl indicates normal range, and lower levels indicate a better outcome.
Improvement in free triiodothyronine levels
时间窗: Baseline (1 month before IVF program begins/1 week before pre-IVF counselling begins), interim assessments (at the start of IVF program, at 3 weeks of IVF program, and at 5 weeks of IVF program).
Blood samples are taken from the participants, of which Hormonal Assay test is then performed. 2.6 - 4.8 pg/ml indicates normal range.
Improvement in depression score
时间窗: Baseline (1 month before IVF program begins/1 week before pre-IVF counselling begins), interim assessments (at the start of IVF program, at 3 weeks of IVF program, and at 5 weeks of IVF program).
Hamilton Depression Rating Scale (HAM-D), Indonesian version, with minimum score of 0 and maximum score of 52. A score of 0-7 indicates no or minimum depression; a score of 8-16 indicates mild depression; a score of 17-23 indicates moderate depression; and a score of 24 and more indicates severe depression. Lower score indicates a better outcome.
Improvement in coping mechanism
时间窗: Baseline (1 month before IVF program begins/1 week before pre-IVF counselling begins), interim assessments (at the start of IVF program, at 3 weeks of IVF program, and at 5 weeks of IVF program).
Coping Orientation to the Problem Experienced (COPE), Indonesian version, divided into 2 scales: adaptive coping (active, acceptance, religious) and maladaptive coping (emotion-focused, avoidance), comprising of 61 questions in total. Shift from dominantly maladaptive coping to adaptive coping indicates a better outcome.
Improvement in norepinephrine levels
时间窗: Baseline (1 month before IVF program begins/1 week before pre-IVF counselling begins), interim assessments (at the start of IVF program, at 3 weeks of IVF program, and at 5 weeks of IVF program).
Blood samples are taken from the participants, of which Hormonal Assay test is then performed. 70-750 pg/dl indicates normal range, and lower levels indicate a better outcome.
次要结局
未报告次要终点
研究者
Feranindhya Agiananda
Staff of Psychiatry Department, Head of Consultation-Liaison Psychiatry Division
Fakultas Kedokteran Universitas Indonesia