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The impact of cognitive behavioural therapy delivered by GPs and nurses on sleep quality

To analyse the effectiveness of cognitive behavioural therapy in primary care delivered by GPs and nurses on the reduction of sleep quality at 12 months in patients with chronic insomnia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10144646
Enrollment
206
Registered
2022-04-05
Start date
2022-11-24
Completion date
Unknown
Last updated
2024-11-12

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

Conditions

Insomnia Mental and Behavioural Disorders

Interventions

Participants are randomised to the intervention or control group (treatment as usual) using computer-generated randomisation. The CBT intervention is delivered face-to-face by nurses and GPs with the
a sleep diary and sleep hygiene brochure were also given to the patient. Review of routines and times
work-at-home routines and times. Session 2: Where are my difficulties, how are my routines and my times? Objective: Find out where the sleep difficulties, routines, and times are. Content: Review of
The quality and efficiency of the sleep will be evaluated by the Pittsburgh sleep quality index and sleep hygiene habits and identify what has been achieved and reflect on what has not been achi

Sponsors

Management Primary care Majorca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 to 75 years old 2. Fulfils diagnostic criteria for insomnia disorder by the Diagnostic and Statistical Manual of Mental Disorder DSM-5

Exclusion criteria

Exclusion criteria: 1. In treatment with CBT-i or other psychological therapies for the treatment of insomnia 2. Insomnia secondary to sleep apnea; work shift; severe mental disorder (psychosis, bipolar disorders, depression higher); history of attempted autolysis; alcohol or drug abuse in the past year; Other sleep disturbances such as restless legs syndrome or parasomnias 3. Neurodegenerative diseases, oncological diseases with poor prognosis, acute or chronic pain secondary to diseases rheumatic and chronic decompensated diseases that produce insomnia

Design outcomes

Primary

MeasureTime frame
Self-reported sleep latency measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months)

Secondary

MeasureTime frame
Current secondary outcome measures as of 27/08/2024: 1. Self-reported sleep duration measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 2. Self-reported sleep efficacy measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 3. Self-reported sleep severity (PSQI total score) measured using the Pittsburgh Sleep Quality Index at baseline and follow-up 4. The use of hypnotic and antidepressant medications (self-reported and measured by The Spanish-language version of the Severity of Dependency Scale) will be used to measure the use of benzodiazepines at 12 months 5. EuroQol Quality of life 5d at baseline at 12 months 6. Direct healthcare expenditures: These will be calculated based on costs related to medications, healthcare visits (PCPs, PCNs, hospital and community emergency services, and hospital specialists), diagnostic and therapeutic procedures, and inpatient care 7. Indirect costs: These will be calculated based on costs associated with work absences _____ Previous secondary outcome measures: 1. Self-reported sleep duration measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 2. Self-reported sleep efficacy measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 3. Self-reported sleep severity measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 4. Number of defined daily doses of benzodiazepines in the last 6 months by the e-prescription system (12 months) 5. EuroQol Quality of life 5d at baseline at 12 months

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026