Protocol summary

Study aim
To evaluate the effectiveness of integrative therapy on individual–social adjustment, resilience, and cognitive emotion regulation in teachers with psychosomatic symptoms.
Design
This quasi-experimental study includes a pre-test, an intervention phase for the experimental group, a post-test, and a three-month follow-up. A total of 36 participants will be randomly assigned to two groups: experimental and control. The study will be conducted in a double-blind manner, ensuring that both participants and those responsible for sample selection and outcome assessment are unaware of group allocations.
Settings and conduct
This study will use sampling of teachers referring to the Didar Center for Mental Disorders in Isfahan, with random assignment to experimental and control groups. It will include pre-test, intervention, post-test, and three-month follow-up assessments, conducted in a double-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Young or middle-aged teachers with psychosomatic symptoms who consent to participate and are not receiving other psychological treatments. Exclusion criteria: Non-adherence (missing more than three sessions), symptom worsening causing psychological harm, or development of a significant chronic physical illness during the study.
Intervention groups
Intervention Group: Participants received nine weekly 90-minute group sessions of integrative therapy based on Feldman’s approach. Control Group: Participants received no intervention during the study period and were offered the intervention after completion of the study.
Main outcome variables
Dependent variables include social adjustment, resilience, and cognitive emotion regulation, measured using the California Social Adjustment Questionnaire, the Connor–Davidson Resilience Questionnaire, and the Garnefski and Kraaij Cognitive Emotion Regulation Questionnaire, respectively.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251121068066N4
Registration date: 2025-12-25, 1404/10/04
Registration timing: prospective

Last update: 2025-12-25, 1404/10/04
Update count: 0
Registration date
2025-12-25, 1404/10/04
Registrant information
Name
Atiyeh Hesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 718 4680
Email address
articlelab2025ir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-26, 1404/10/05
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Integrative Therapy on Individual-Social Adjustment, Resilience, and Cognitive Emotion Regulation in Teachers with Psychosomatic Symptoms
Public title
The Effectiveness of Integrative Therapy on Individual-Social Adjustment, Resilience, and Cognitive Emotion Regulation in Teachers with Psychosomatic Symptoms
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Exhibiting psychosomatic symptoms based on the interview Being a young or middle-aged teacher. No history of acute psychological disorders (e.g., depression, anxiety) based on psychiatric history. Ability and willingness to provide informed consent and participate in the study. No receipt of psychological treatment for the control group. No psychological treatment other than the study for the experimental group.
Exclusion criteria:
Lack of cooperation with the researcher, including irregular attendance at sessions or failure to complete treatment protocol assignments. Irregular attendance (more than three missed sessions). Worsening of the condition due to the intervention leading to psychological harm, such as suicidal thoughts. Occurrence of specific events, such as the development of another chronic physical illness during the study period.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to one of two study groups: an experimental group (receiving the intervention) and a control group (receiving no intervention). A total of 36 participants were enrolled, with 18 participants allocated to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is conducted using a double-blind design. Both the participants and the individual responsible for sample selection and outcome assessment are unaware of the group assignments. Participants do not have any information regarding whether they are allocated to the experimental or control group. Group allocation is concealed during the study period, and blinding is maintained throughout data collection and assessment to minimize bias.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Specialized Committee on Ethics in Biomedical Research
Street address
Daneshgah Blvd, Najafabad, Isfahan Province
City
Najafabad
Province
Isfehan
Postal code
8514143131
Approval date
2025-05-01, 1404/02/11
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1404.026

Health conditions studied

1

Description of health condition studied
Psychosomatic
ICD-10 code
F45.0
ICD-10 code description
Somatization disorder

Primary outcomes

1

Description
Social Adjustment: Measured using the California Social Adjustment Questionnaire.
Timepoint
Measurements will be taken at three stages: pre-test (before intervention), post-test (immediately after intervention), and three-month follow-up.
Method of measurement
The California Personal-Social Adjustment Questionnaire (CPI), measures life adjustment across two domains: personal and social adjustment. The questionnaire contains 180 yes/no items divided into 12 subscales. Items 1–90 assess personal adjustment, while items 91–180 assess social adjustment.

2

Description
Resilience: Measured using the Connor–Davidson Resilience Questionnaire.
Timepoint
Measurements will be taken at three stages: pre-test (before intervention), post-test (immediately after intervention), and three-month follow-up.
Method of measurement
Resilience is measured using the Connor–Davidson Resilience Questionnaire (CD-RISC), which consists of 25 items rated on a Likert scale from 0 (completely false) to 5 (always true). The questionnaire evaluates the participant’s ability to cope with stress and adapt to challenging situations, providing a total score that reflects overall resilience.

3

Description
Cognitive Emotion Regulation: Cognitive emotion regulation refers to the cognitive strategies used to manage emotionally arousing information. It is measured using the Garnefski and Kraaij Cognitive Emotion Regulation Questionnaire (CERQ).
Timepoint
Measurements will be taken at three stages: pre-test (before intervention), post-test (immediately after intervention), and three-month follow-up.
Method of measurement
Cognitive Emotion Regulation: Measured using the Cognitive Emotion Regulation Questionnaire (CERQ) developed by Garnefski and Kraaij (2006). The questionnaire contains 18 items assessing adaptive and maladaptive strategies across 9 components: self-blame, rumination, catastrophizing, blaming others, positive refocusing, refocusing on planning, acceptance, positive reappraisal, and perspective-taking. Items are rated on a 5-point Likert scale from 1 (never) to 5 (always).

Secondary outcomes

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Intervention groups

1

Description
Intervention group: Participants received nine weekly group sessions of integrative therapy based on Feldman’s approach, incorporating psychodynamic and cognitive components. Each session lasted 90 minutes.
Category
Treatment - Other

2

Description
Control group: Participants received no intervention during the study period and were offered the intervention after completion of the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Didar Center for Counseling Mental Disorders and Problems
Full name of responsible person
Dr.Gholamreza Talebi
Street address
2nd Floor, Padna Building, No. 44, Amin Alley, Sheyri Bridge, opposite Seyed-al-Shohada Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8135866531
Phone
+98 31 3237 1841
Fax
Email
rezatalebi@iau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Iman Sadeqkhani
Street address
Najafabad branch Islamic Azad University, Daneshgah Blvd, Najafabad, Isfahan
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 3205
Email
info @ iaun.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
50
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
Gholamreza Talebi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
2nd Floor, Padna Building, No. 44, Amin Alley, Sheyri Bridge, opposite Seyed-al-Shohada Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8135866531
Phone
+98 913 317 0681
Email
rezatalebi@iau.ac.ir
Web page address
https://orcid.org/0009-0006-1067-2048

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamreza Talebi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
2nd Floor, Padna Building, No. 44, Amin Alley, Sheyri Bridge, opposite Seyed-al-Shohada Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8514143131
Phone
+98 913 317 0681
Email
rezatalebi@iau.ac.ir
Web page address
https://orcid.org/0009-0006-1067-2048

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirhossein Emadi Andani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Najafabad branch Islamic Azad University, Daneshgah Blvd, Najafabad, Isfahan
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 990 789 7820
Email
amirhosein.emadi13977@gmail.com
Web page address

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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