An interventional study of Cognitive Behavioral Therapy in Cognitive Behavioral Therapy, Hormone Disturbance and In Vitro Fertilization, sponsored by Fakultas Kedokteran Universitas Indonesia. Recruiting at 1 site in Indonesia. Open to female participants aged 25 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Fakultas Kedokteran Universitas Indonesia · Not applicable, Interventional, and Treatment
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:
Researchers will compare CBT to no intervention to see if CBT is effective in improving psychoneuroendocrine aspects.
Participants will
322 studies on the registry are indexed under Endocrine System Diseases; 51 are open to participants now.
This study's planned enrollment of 75 is close to the median of 69 across 221 interventional studies indexed under Endocrine System Diseases.
Browse Endocrine System Diseases studies →Fakultas Kedokteran Universitas Indonesia is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Structured, short-term psychological treatment in the field of cognition that aims to shape adaptive thoughts and behavior.
Behavioral: Cognitive Behavioral Therapy
Administration of information and education regarding in vitro fertilization according to each patient's needs and current stage of treatment.
Cognitive Behavioral Therapy
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
Improvement in norepinephrine levels
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.
Time frame: 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).
Improvement in free triiodothyronine levels
Blood samples are taken from the participants, of which Hormonal Assay test is then performed. 2.6 - 4.8 pg/ml indicates normal range.
Time frame: 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).
Plan to share: No
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Fakultas Kedokteran Universitas Indonesia