Effectiveness of CBT in Improving Psycho-Neuro-Endocrine... | NCT06521957 | Trialant

Effectiveness of CBT in Improving Psycho-Neuro-Endocrine... | NCT06521957 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25040027	Background	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.
23212833	Background	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.