The effectiveness of cognitive-behavioral counseling based on the "interactive cognitive subsystems" approach on anxiety, depression, and feelings of shame and guilt
Determining the effectiveness of cognitive-behavioral counseling based on the "interactive cognitive subsystems" approach on anxiety, depression, and feelings of shame and guilt in infertile couples referring to psychological centers in Ahvaz
Design
A controlled clinical trial with parallel groups, single-blind, randomized, on 30 pairs. Random Allocation Software was used for randomization.
Settings and conduct
The study will be conducted at psychological centers in Ahvaz.
Infertile couples will be selected after screening based on inclusion criteria.
Random allocation to groups will be performed by an independent research assistant.
Cognitive-behavioral intervention based on the interacting cognitive subsystems approach will be delivered.
Outcome assessors and data analysts will remain blinded.
Data collection will be carried out using standardized questionnaires before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile couples aged 25-45 years.
Diagnosis of infertility by a gynecologist.
Presence of measurable anxiety or depression symptoms.
Informed consent and willingness of both spouses.
Exclusion criteria: History of severe psychiatric disorders.
Current use of psychiatric medications.
Concurrent receipt of any psychotherapy.
Unwillingness of either spouse to continue participation.
Intervention groups
The intervention group consists of infertile couples who receive cognitive-behavioral counseling sessions based on the “interactive cognitive subsystems” approach. The goal of these sessions is to reduce their anxiety, depression, and feelings of shame and guilt.
The control group consists of infertile couples who receive no intervention and are simply under routine clinical supervision.
Main outcome variables
Anxiety, Depression, Shame, Guilt.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250704066367N1
Registration date:2025-09-14, 1404/06/23
Registration timing:prospective
Last update:2025-09-14, 1404/06/23
Update count:0
Registration date
2025-09-14, 1404/06/23
Registrant information
Name
Syedeh Zahra Tabatabayi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3111 1111
Email address
ztabatabayi0@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-01, 1404/07/09
Expected recruitment end date
2026-03-01, 1404/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral counseling based on the "interactive cognitive subsystems" approach on anxiety, depression, and feelings of shame and guilt
Public title
The impact of cognitive-behavioral approach on anxiety, depression, and feelings of shame and guilt.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age criterion of 25-45 years for both spouses.
Diagnosis of infertility by a gynecologist.
Presence of measurable anxiety or depression.
Informed consent and willingness of both spouses.
Exclusion criteria:
History of severe psychiatric disorder.
Current use of psychiatric medications.
Concurrent receipt of psychotherapy.
Unwillingness of one spouse to participate.
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method used in this study is block randomization with a block size of 4. The allocation sequence will be generated using Random Allocation Software and placed in consecutive sealed envelopes. After final confirmation of each participant's entry conditions, the researcher will open the envelopes in order to allocate individuals to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study will be designed as a single-blind study. In this design, only the outcome assessors and data analysts will be kept unaware of the allocation of couples to the intervention and control groups. This will ensure that data collection and analysis of the results are free from any bias. Participating couples will be fully aware of the nature of the study and their treatment group, as this information will be provided transparently during the informed consent process. The principal investigator and treatment personnel will also be informed of the details of group allocation to enable safe and effective delivery of the interventions. This approach will ensure that data integrity and impartiality in the assessment of the results are maintained.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Ahvaz Branch
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Approval date
2025-08-30, 1404/06/08
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.412
Health conditions studied
1
Description of health condition studied
Feelings of shame and guilt
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fertility-Related Quality of Life Index (FERIS)
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Fertility-Related Quality of Life Questionnaire (Ferticol، 2011)
Secondary outcomes
1
Description
Depression
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Beck Depression Inventory-II
2
Description
Feelings of shame and guilt
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Orth Shame and Guilt Scale Questionnaire
3
Description
Anxiety,
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Beck Anxiety Inventory (BAI)
Intervention groups
1
Description
Intervention group: Intervention group (infertile couples): This group will receive a cognitive-behavioral counseling protocol based on the interacting cognitive subsystems approach. The intervention will consist of 12 structured 90-minute sessions conducted weekly. Session content will include identifying and modifying maladaptive thought patterns, managing negative emotions, and improving marital communication related to infertility.
Category
N/A
2
Description
Control group: Control group (infertile couples): This group will receive no psychological intervention and will only be placed on a waiting list. Pre- and post-test assessments using standardized questionnaires will be conducted for this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Ahvaz Unit
Full name of responsible person
Siyed Kazam Mousavi
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pejman Taghipour Birgani
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Siyed Kazam Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Family Counseling
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Siyed Kazam Mousavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Family Counseling
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Syedeh Zahra Tabatabayi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Consulting
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6175953846
Phone
+98 61 3334 8420
Fax
Email
ztabatabayi0@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available