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Studying the effectiveness of emotion-focused therapy on anxiety sensitivity, perceived stress, action flexibility, and rumination in women undergoing medical treatment with type 2 diabetes in Ahvaz city.

Protocol summary

Study aim
The aim of this study is to examine the effectiveness of Emotion-Focused Therapy in reducing anxiety sensitivity, perceived stress, and rumination, and in increasing psychological flexibility in women with type 2 diabetes undergoing pharmacological treatment.
Design
A single-blind, randomized, parallel-group, phase 2 clinical trial on 40 patients. For randomization, a physical lottery method (equivalent to traditional randomization methods) was used.
Settings and conduct
Diabetes Clinics in Ahvaz (2025). 40 patients. Physical randomization. - Intervention: Group EFT (8 sessions) - Control: Usual drug therapy Blinded assessor. Informed consent obtained.
Participants/Inclusion and exclusion criteria
Participants must be diabetic women aged 20 to 40 with at least a high school diploma, no mental or neurological disorders, no substance use, and committed to treatment. Withdrawal from the study will occur in case of absence, violation of rules, or lack of cooperation.
Intervention groups
Experimental Group (Receiving EFT): - Intervention: Group-based Emotion-Focused Therapy (EFT) - Protocol: Watson et al.'s model (2005) - Structure: 8 weekly sessions, 90 minutes each - Content: Emotion regulation, reduction of rumination, enhancement of psychological flexibility Control Group (Receiving TAU): - Intervention: Treatment as usual for diabetes (pharmacotherapy without psychotherapy) - Conditions: Continuation of routine medications, no psychotherapy during the study, option to receive EFT after the study
Main outcome variables
1. Anxiety Sensitivity ۲. Perceived Stress ۳. Psychological Flexibility ۴. Rumination

General information

Reason for update
Acronym
EFSRD
IRCT registration information
IRCT registration number: IRCT20250629066290N1
Registration date: 2025-07-16, 1404/04/25
Registration timing: registered_while_recruiting

Last update: 2025-07-16, 1404/04/25
Update count: 0
Registration date
2025-07-16, 1404/04/25
Registrant information
Name
Zeinab Ahangarpor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4448 5724
Email address
zeinabahangarpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-15, 1404/04/24
Expected recruitment end date
2026-01-14, 1404/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of emotion-focused therapy on anxiety sensitivity, perceived stress, action flexibility, and rumination in women undergoing medical treatment with type 2 diabetes in Ahvaz city.
Public title
The effect of emotion-focused therapy on anxiety, stress, and repetitive thoughts in diabetic women in Ahvaz
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20 to 40 years with type 2 diabetes No history of substance use and no current or previous major psychiatric symptoms; no history of brain diseases such as brain tumors Not participating in other psychotherapy sessions for at least one month before the study Signing a written informed consent form and commitment to participate in treatment sessions Minimum education level: diploma (high school degree) Definite diagnosis of type 2 diabetes by a specialist physician
Exclusion criteria:
Having brain diseases such as brain tumors Presence of current or past psychotic symptoms or severe psychiatric disorders Substance abuse Participation in other psychotherapy sessions at least one month before the study Not having at least a high school diploma No confirmed diagnosis of type 2 diabetes by a specialist physician Unwillingness to participate or refusal to sign the written informed consent form
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
1.Randomization Method & Description: - Method Used:Simple Random Allocation - Participants were randomly assigned (via lottery draw) to either the intervention or control group. - No manipulation or bias in group selection was applied. 2. Unit of Randomization: - Individual:Each participant was randomized independently. 3. Stratification (if applicable): - Not Used: - Due to the relatively small sample size (N=40) and homogeneity of the study population (all women with type 2 diabetes), stratification was not applied. 4. Randomization Tool: - Manual (Lottery Draw): - Names were written on separate papers, mixed in a container, and drawn randomly. - Digital tools (e.g., randomization software) were not used due to practical constraints. 5. Sequence Generation: - Unpredictable Sequence: - The order of drawing names from the container determined the random sequence. 6. Allocation Concealment: - Partial Concealment: - Researchers and participants were aware of group allocation post-randomization. - However, outcome assessments (pre-test/post-test) were conducted by blinded assessors to minimize measurement bias.
Blinding (investigator's opinion)
Not blinded
Blinding description
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 of Ahvaz
Street address
Ahvaz Golestan-Farhangshahr Highway
City
ahvaz
Province
Khouzestan
Postal code
37333- 61349
Approval date
2025-04-05, 1404/01/16
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.002

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
1. Anxiety Sensitivity - Measurement: Total score of the Anxiety Sensitivity Index-3 (ASI-3) - Change indicator:Reduction of ≥30% from baseline. Primary Outcomes:Change in Anxiety Sensitivity (ASI-3) score at the end of the intervention
Timepoint
1. Pre-test:Measurement of dependent variable (anxiety sensitivity) before the intervention began for both experimental and control groups. 2. Post-test:Re-measurement of variable immediately after completing the treatment sessions (after 8 sessions of Emotion-Focused Therapy). 3.Follow-up:Measurement of variable one month after the intervention ended to assess the durability of treatment effects.
Method of measurement
1. Anxiety Sensitivity - Tool: Anxiety Sensitivity Index (ASI) - Original version:* Reiss et al. (1985) - Persian version:Used in domestic studies with confirmed validity and reliability - Description: - Consists of 16 items assessing fear of anxiety symptoms (e.g., "When my heart beats rapidly, I get scared"). -Three subscales: Physical, cognitive, and social concerns.- Scoring: 5-point Likert scale (0=Not at all to 4=Very much).

2

Description
2. Perceived Stress - Measurement: Total score of the Perceived Stress Scale-10 (PSS-10) -Change indicator: Reduction of ≥25% from baseline. Primary Outcomes:Change in Perceived Stress (PSS-10) score at the end of the intervention.
Timepoint
1. Pre-test:Measurement of dependent variable ( perceived stress) before the intervention began for both experimental and control groups. 2. Post-test:Re-measurement of variable immediately after completing the treatment sessions (after 8 sessions of Emotion-Focused Therapy). 3.Follow-up:Measurement of variable one month after the intervention ended to assess the durability of treatment effects.
Method of measurement
2. Perceived Stress - Tool: Perceived Stress Scale (PSS) - Original version:* Cohen et al. (1983)- Persian version:Safaei & Shokri (2014) with satisfactory validity and reliability- Description: - 14 items evaluating an individual’s perception of stressful situations (e.g., "How often have you felt nervous or stressed in the past month?").- 5-point Likert scale (0=Never to 4=Very often).

3

Description
3. Psychological Flexibility - Measurement: Total score of the Connor-Davidson Resilience Scale-10 (CD-RISC-10) - Change indicator: Increase of ≥20% from baseline. Primary Outcomes: Change in Psychological Flexibility (CD-RISC-10) score at 1-month follow-up.
Timepoint
1. Pre-test:Measurement of dependent variable (cognitive flexibility) before the intervention began for both experimental and control groups. 2. Post-test:Re-measurement of variable immediately after completing the treatment sessions (after 8 sessions of Emotion-Focused Therapy). 3.Follow-up:Measurement of variable one month after the intervention ended to assess the durability of treatment effects.
Method of measurement
3. Cognitive Flexibility -Tool: Cognitive Flexibility Inventory (CFI) - Original version:Dennis & Vander Wal (2010)- Persian version:Ghorbani & Kaviani (2015)- Description:- 20 items measuring the ability to adapt thinking to new conditions (e.g., "I can think of multiple solutions to a problem"). 7-point Likert scale (1=Strongly disagree to 7=Strongly agree).

4

Description
4.Rumination -Measurement: Total score of the Ruminative Response Scale (RRS) - Change indicator: Reduction of ≥15% from baseline.Primary Outcomes: Change in Rumination (RRS) score at the end of the intervention
Timepoint
1. Pre-test:Measurement of dependent variable (Rumination) before the intervention began for both experimental and control groups. 2. Post-test:Re-measurement of variable immediately after completing the treatment sessions (after 8 sessions of Emotion-Focused Therapy). 3.Follow-up:Measurement of variable one month after the intervention ended to assess the durability of treatment effects.
Method of measurement
4. Rumination - Tool: Ruminative Responses Scale (RRS) - Original version: Nolen-Hoeksema & Morrow (1991) - Persian version:Bagherinejad et al.(2011)- Description:- 22 items assessing repetitive negative thoughts (e.g., "I think about how sad I feel").-4-point Likert scale (1=Almost never to 4=Almost always). --- Procedure1. Pre-test: All participants completed the questionnaires before the intervention. 2. Post-test: Both groups were reassessed after 8 sessions of Emotion-Focused Therapy (EFT).3. Follow-up: The experimental group was reevaluated one month later to assess the persistence of effects.Data Analysis - A Mixed ANOVA (Repeated Measures ANOVA) was used to compare changes across three time points (pre-test, post-test, follow-up) between the two groups.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: - Description:This group consisted of 20 women with type 2 diabetes who received Emotion-Focused Therapy (EFT).- Key Characteristics: - Intervention Method:- 8 weekly sessions (90 minutes each)- Protocol based on Greenberg's (2004) model and the manual by Rasouli & Pour Ebrahim (2010) - Focused on emotion regulation, emotional processing, and reduction of rumination- Concurrent Conditions:- Continued standard pharmacological treatment (no dosage changes during the study)- No concurrent participation in other psychotherapy
Category
Treatment - Other

2

Description
Control group: Description:This group consisted of 20 women with type 2 diabetes who received only standard pharmacological treatment and no psychotherapy intervention.- Key Features:- Follow-up method: - Received routine medical care (same as the intervention group)- Did not receive Emotion-Focused Therapy (EFT) or any structured psychotherapy during the study- Controlled conditions:- Assessed at the same time intervals (pre-test, post-test, follow-up)- Were unaware of the intervention group’s session content (partial blinding)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Research Center of Ahvaz
Full name of responsible person
Sasan Bavi
Street address
Diabetes Research Center, Health Research Institute, Shafa Hospital, Golestan Boulevard, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311 2890
Email
diabet-rc@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pejman Taghipour Birgani
Street address
Ahvaz, Farhang Shahr, Ahvaz Azad University
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
+98 61 3316 3394
Email
p_taghipour@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
Private
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
Zainab Ahangarpour
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.107, West 20th Alley, Kianabad, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6155754816
Phone
+98 61 3337 8937
Email
zeinabahangarpour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sasan Bavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ahvaz, Farhang Shahr, Ahvaz Azad University
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
+98 916 607 5133
Email
Sasanbavi2@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sasan Bavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ahvaz, Farhang Shahr, Ahvaz Azad University
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
+98 916 607 5133
Email
Sasanbavi2@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
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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