Effectiveness of CBT in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program
NCT ID: NCT06521957
Last Updated: 2024-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2023-07-05
2025-06-01
Brief Summary
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* 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.
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cognitive Behavioral Therapy
Structured, short-term psychological treatment in the field of cognition that aims to shape adaptive thoughts and behavior.
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy
Treatment As Usual
Administration of information and education regarding in vitro fertilization according to each patient's needs and current stage of treatment.
No interventions assigned to this group
Interventions
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Cognitive Behavioral Therapy
Cognitive Behavioral Therapy
Eligibility Criteria
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Inclusion Criteria
* 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
25 Years
42 Years
FEMALE
Yes
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Responsible Party
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Feranindhya Agiananda
Staff of Psychiatry Department, Head of Consultation-Liaison Psychiatry Division
Locations
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Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Feranindhya Agiananda
Role: primary
Artasya Karnasih
Role: backup
References
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Toufexis D, Rivarola MA, Lara H, Viau V. Stress and the reproductive axis. J Neuroendocrinol. 2014 Sep;26(9):573-86. doi: 10.1111/jne.12179.
An Y, Sun Z, Li L, Zhang Y, Ji H. Relationship between psychological stress and reproductive outcome in women undergoing in vitro fertilization treatment: psychological and neurohormonal assessment. J Assist Reprod Genet. 2013 Jan;30(1):35-41. doi: 10.1007/s10815-012-9904-x. Epub 2012 Dec 5.
Schliep KC, Mumford SL, Vladutiu CJ, Ahrens KA, Perkins NJ, Sjaarda LA, Kissell KA, Prasad A, Wactawski-Wende J, Schisterman EF. Perceived stress, reproductive hormones, and ovulatory function: a prospective cohort study. Epidemiology. 2015 Mar;26(2):177-84. doi: 10.1097/EDE.0000000000000238.
Other Identifiers
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ND308/UN2.F1/ETIK/PPM0002/2023
Identifier Type: -
Identifier Source: org_study_id
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