Effectiveness of CBT in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program

University of Indonesia (UI)

Status: Enrolling

Conditions: In Vitro Fertilization; Hormone Disturbance; Cognitive Behavioral Therapy

Treatments: Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06521957

ND308/UN2.F1/ETIK/PPM0002/2023

Details and patient eligibility

About

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.

Full 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

Enrollment: 75 estimated patients

Sex: Female

Ages: 25 to 42 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups

Cognitive Behavioral Therapy

Experimental group

Description:

Structured, short-term psychological treatment in the field of cognition that aims to shape adaptive thoughts and behavior.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Treatment As Usual

No Intervention group

Description:

Administration of information and education regarding in vitro fertilization according to each patient's needs and current stage of treatment.