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IRCT20250629066290N1 IRCT 2025-07-16 Islamic Azad University The effect of emotion-focused therapy on anxiety, stress, and repetitive thoughts in diabetic women in Ahvaz EFSRD 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. 2025-07-15 anticipated 40 Complete https://irct.ir/trial/84537 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Type 2 Diabetes. Intervention 1: 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. Intervention 2: 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). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Zainab Ahangarpour
No.107, West 20th Alley, Kianabad, Ahvaz
ahvaz Iran (Islamic Republic of) 6155754816 +98 61 3337 8937 zeinabahangarpour@gmail.com Islamic Azad University scientific Sasan Bavi
Ahvaz, Farhang Shahr, Ahvaz Azad University
Ahvaz Iran (Islamic Republic of) ۶۱۳۴۹۳۷۳۳۳ +98 916 607 5133 Sasanbavi2@gmail.com Islamic Azad University Iran (Islamic Republic of) 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 20 years 40 years Female 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 E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Drugs 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 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) 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. 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. 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.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. Islamic Azad University Approved 2025-04-05 Ethics Committee of Islamic Azad University of Ahvaz Ahvaz Golestan-Farhangshahr Highway ahvaz Khouzestan Iran (Islamic Republic of)