Cognitive Behavioral Therapy, Hormone Disturbance, In Vitro Fertilization
Conditions
Keywords
Cognitive Behavioral Therapy, Psycho-Neuro-Endocrine, In Vitro Fertilization
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALCognitive Behavioral Therapy
Cognitive Behavioral Therapy
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Having one or multiple psychotic disorder(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in anxiety score | 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 depression score | 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 | 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 cortisol levels | 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 norepinephrine levels | 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. |
| Improvement in free triiodothyronine levels | 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. |
Countries
Indonesia
Contacts
Primary ContactFeranindhya Agiananda
Backup ContactArtasya Karnasih
Outcome results
None listed