Effectiveness of mentalization based group therapy in fibromyalgia

Effectiveness of mentalization based group therapy (MBT_G) on sleep problems, feeling of fatigue and emotional regulation of fibromyalgia patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250610066163N1

Enrollment

Registered

2025-07-13

Start date

2025-08-06

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

Fibromyalgia. Fibromyalgia

Interventions

Intervention 1: Intervention group: In this study, the mentalization-based group therapy was derived from the intervention developed by Bateman and Fonagy in 2016. This protocol has been used in sever

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients between eighteen and sixty years of age with fibromyalgia diagnosed by a rheumatologist based on the clinical criteria of the American College of Rheumatology (2010); Minimum high school education; Subjects should not participate in any psychological services training course and should not be under specific drug treatment at the same time as this study.

Exclusion criteria

Exclusion criteria: Failure to attend more than one intervention session Unwillingness to continue attending intervention sessions Presence of metabolic bone disease, diabetes, liver disease, chronic renal failure, cancer, heart disease, and psychiatric disorders such as major depression Undergoing psychological treatment concurrently with the present study

Design outcomes

Primary

Measure	Time frame
Sleep Problems. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention), and 6 months after the end of the intervention. Method of measurement: Pittsburgh sleep quality index (PSQI).;Feeling Of Fatigue. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention), and 6 months after the end of the intervention. Method of measurement: Chalder Fatigue Scale.;Emotional Regulation. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention), and 6 months after the end of the intervention. Method of measurement: Gross and John Emotion Regulation Questionnaire.	—

Measure

Time frame

Sleep Problems. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention), and 6 months after the end of the intervention. Method of measurement: Pittsburgh sleep quality index (PSQI).;Feeling Of Fatigue. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention), and 6 months after the end of the intervention. Method of measurement: Chalder Fatigue Scale.;Emotional Regulation. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention), and 6 months after the end of the intervention. Method of measurement: Gross and John Emotion Regulation Questionnaire.

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Secondary

Measure	Time frame
Quality of life. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention) and 6 months after the end of the intervention. Method of measurement: WHOQOL-BREF.;General Health. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention) and 6 months after the end of the intervention. Method of measurement: General Health Questionnaire (GHQ).	—

Measure

Time frame

Quality of life. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention) and 6 months after the end of the intervention. Method of measurement: WHOQOL-BREF.;General Health. Timepoint: At the beginning of the study (before the intervention), at the end of the study (week 10/after the end of the intervention) and 6 months after the end of the intervention. Method of measurement: General Health Questionnaire (GHQ).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaghar Karimi Mianji

Islamic Azad University

Saghi.kary@gmail.com+98 71 3233 6740

Outcome results

None listed

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