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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2025-06-01

Brief Summary

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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

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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

Conditions

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Cognitive Behavioral Therapy Hormone Disturbance In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioral Therapy

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Feranindhya Agiananda

Staff of Psychiatry Department, Head of Consultation-Liaison Psychiatry Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Feranindhya Agiananda

Role: CONTACT

08161696160

Artasya Karnasih

Role: CONTACT

082111163002

Facility Contacts

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Feranindhya Agiananda

Role: primary

08161696160

Artasya Karnasih

Role: backup

082111163002

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.

Reference Type BACKGROUND
PMID: 25040027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23212833 (View on PubMed)

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.

Reference Type RESULT
PMID: 25643098 (View on PubMed)

Other Identifiers

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ND308/UN2.F1/ETIK/PPM0002/2023

Identifier Type: -

Identifier Source: org_study_id

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