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Effectiveness of Transdiagnostic Sleep and Circadian Intervention on improving sleep problems

Comparing the effectiveness of Transdiagnostic Sleep and Circadian Intervention and Mindfulness Based Therapy on treatment outcome of patients with sleep-wake disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240826062867N1
Enrollment
34
Registered
2024-09-20
Start date
2024-09-09
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Sleep-Wake Disorders. Sleep Disorders

Interventions

Intervention 1: Intervention group: Transdiagnostic Sleep and Circadian Intervention (TranS-C) consists of three sets of modules: four cross-cutting modules (Case Formulation, Sleep andCircadian Educa

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 60 Years

Inclusion criteria

Inclusion criteria: Aged 22-60 years Having One or more of the following sleep or circadian problems for 3 months: =30 minutes to get to sleep on three or more nights per week, Waking in the middle of the night for=30 minutes on three or more nights per week, Obtaining <6 h of sleep per night on three or more nights per week. Obtaining more than 9 hours of sleep per 24 hour period (i.e., nighttime sleep plus daytime napping), 3 or more nights per week, More than 2.78 h of variability in sleep-wake schedule across 1 week, Bedtime later than 2:00 a.m. on three or more nights per week Having adequate opportunity to sleep.

Exclusion criteria

Exclusion criteria: Meeting DSM–5 criteria for one of major mental disorder including schizophrenia, bipolar disorder, sever major depression disorder based on SCID Meeting DSM–5 criteria for one of other sleep-wake disorder including narcolepsy, nightmare disorder, restless legs syndrome, breathing-related sleep disorders, non-REM (NREM) sleep arousal disorders, REM sleep behavior disorder, and substance-or medication-induced sleep disorder, based on SCID Having serious suicidal ideation Change in the type and dosage of psychiatric drugs used during the psychotherapy period Absence of more than 3 sessions in psychotherapy Having night shifitwork

Design outcomes

Primary

MeasureTime frame
Sleep and Circadian Problems. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Daily Sleep Dairy, Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance (SD) Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep-Related Impairment (SRI).;Sleep Quality. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Pittsburgh Sleep Quality Index.;Insomnia Severity. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Insomnia Severity Index.;Fatigue. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Fatigue Severity Scale.;Sleepiness. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Epworth sleepiness scale.;Morningness-Eveningness. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Morningness-Eveningness Questionnaire.

Secondary

MeasureTime frame
Depression symptom severity. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Hospital Anxiety Depression Scale.;Anxiety symptom severity. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Hospital Anxiety Depression Scale.;Dysfunction. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Sheehan Disability Scale.;Expectation of therapy. Timepoint: Before and after interventions. Method of measurement: Expectation of therapy interview.;Experience of therapy. Timepoint: Before and after interventions. Method of measurement: Experience of therapy interview.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahime AhmadianVargahan

Iran University of Medical Sciences

ahmadian.fahime@yahoo.com+98 901 873 6844

Outcome results

None listed

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