About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Having one or multiple psychotic disorder(s)
Trial design
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy
BehavioralCognitive Behavioral Therapy
Treatment groups
Trial outcomes
Primary outcomes
Improvement in anxiety score
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 depression score
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
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 cortisol levels
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.
Sponsors and contacts
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