Clinical trial NCT06521957: Effectiveness of CBT in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program
Official title: The Effectiveness of Cognitive Behavioral Therapy in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Behavioral Therapy
Hormone Disturbance
In Vitro Fertilization
Keywords: Cognitive Behavioral Therapy
Psycho-Neuro-Endocrine
In Vitro Fertilization
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 75
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Improvement in anxiety score
timeFrame: 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).
measure: Improvement in depression score
timeFrame: 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).
measure: Improvement in coping mechanism
timeFrame: 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).
measure: Improvement in cortisol levels
timeFrame: 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).
measure: Improvement in norepinephrine levels
timeFrame: 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).
measure: Improvement in free triiodothyronine levels
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.