NCT06521957

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

July 17, 2024

Last Update Submit

July 23, 2024

Conditions

Cognitive Behavioral TherapyHormone DisturbanceIn Vitro Fertilization

Keywords

Cognitive Behavioral TherapyPsycho-Neuro-EndocrineIn Vitro Fertilization

Outcome Measures

Primary Outcomes (6)

  • Improvement in anxiety score

    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.

    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).

  • Improvement in depression score

    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.

    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).

  • Improvement in coping mechanism

    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.

    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).

  • Improvement in cortisol levels

    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.

    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).

  • Improvement in norepinephrine levels

    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.

    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).

  • Improvement in free triiodothyronine levels

    Blood samples are taken from the participants, of which Hormonal Assay test is then performed. 2.6 - 4.8 pg/ml indicates normal range.

    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).

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy

Treatment As Usual

NO INTERVENTION

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

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy

Eligibility Criteria

Age25 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Having one or multiple psychotic disorder(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25040027BACKGROUND

  • 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.

    PMID: 23212833BACKGROUND

  • 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.

    PMID: 25643098RESULT

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Feranindhya Agiananda

CONTACT

08161696160feranindhya@gmail.com

Artasya Karnasih

CONTACT

082111163002artasya.karnasih@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff of Psychiatry Department, Head of Consultation-Liaison Psychiatry Division

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 26, 2024

Study Start

July 5, 2023

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)