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Comparing the effects of mindfulness interventions based on stress reduction and cognitive behavioral therapy on emotional self-regulation, sleep quality, and self-efficacy in women with type 2 diabetes

Comparing the effects of mindfulness interventions based on stress reduction and cognitive behavioral therapy on emotional self-regulation, sleep quality, and self-efficacy in women with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250519065797N1
Enrollment
30
Registered
2025-06-25
Start date
2025-05-30
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with Type 2 Diabetes experiencing difficulties in emotional regulation, sleep quality, and psychological self-efficacy. Type 2 diabetes mellitus

Interventions

The present study is a quasi-experimental study with a pretest-posttest design with a control group. First, through a call and medical records, eligible individuals were identified based on the inclus

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: Diagnosis of type 2 diabetes based on expert opinion Age range between 40 and 60 years. Having at least a high school diploma

Exclusion criteria

Exclusion criteria: Diagnosis of severe psychiatric disorders (e.g., schizophrenia, bipolar I disorder, or major depressive disorder with suicidal ideation) Ongoing or recent participation (within the past 3 months) in structured psychological interventions, including CBT or mindfulness-based therapies Concurrent enrollment in another interventional clinical study Presence of severe chronic medical conditions (e.g., end-stage renal disease, active cancer, or serious cardiovascular disease) Lack of informed consent or unwillingness to voluntarily participate in the study

Design outcomes

Primary

MeasureTime frame
Emotional self-regulation is considered the primary outcome variable of this study. It refers to the individual’s ability to identify, control, and manage their emotions effectively and adaptively. This variable will be measured using validated psychometric questionnaires. The main goal of the study is to assess changes in emotional self-regulation levels following mindfulness-based stress reduction and cognitive-behavioral therapy interventions. Timepoint: Baseline (Pre-intervention):Farvardin 1404 (April 2025)Post-intervention: First week of Khordad 1404 (May 2025). Method of measurement: The emotional self-regulation variable will be measured using the Emotion Regulation Questionnaire (ERQ) developed by Gross & John. This tool includes 10 items assessing two emotional regulation strategies: cognitive reappraisal and expressive suppression. Participants respond using a 5-point Likert scale ranging from "strongly disagree" to "strongly agree."The ERQ has demonstrated good validity and reliability in both international and local studies. Total scores indicate the degree of use of emotion regulation strategies. Data will be collected at two time points (pre-test, post-test) and analyzed.;Sleep Quality. Timepoint: Baseline (Pre-intervention):Farvardin 1404 (April 2025)Post-intervention: First week of Khordad 1404 (May 2025). Method of measurement: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). This standardized self-report instrument includes 19 items that measure seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.The PSQI has demonstrated high validity and reliability in both international and Iranian studies. Data will be collected at two time points: pre-test, post-test, and follow-up.;Self efficacy. Timepoint: Baseline (Pre

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra mirhaj

Islamic Azad University

noormirhajz@gmail.com+98 935 276 4613

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026