Feasibility and Acceptability of Cognitive Behavioral Therapy for Chronic Insomnia in a Primary Care

NCT04565223 | Completed

• 1 other identifier: PI14/019
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot-feasibility study of a cluster parallel randomized design comparing CBT-i against usual care (UC) was performed at two primary health care centers in Majorca, Spain. Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI more than 8) and had insomnia longer than 3 months; and did or did not use a hypnotic medication. 25 GPs and nurses and 32 patients were randomly allocated to two groups: The outcome of the trial was improving the quality of sleep. Other primary outcomes on feasibility and applicability of the intervention were collected through nominal groups. Description of usual care was described through previous studies. Moreover we assessed recruitment process, compliance with the intervention sessions, and patient's retention.

Conditions

Insomnia Chronic

Keywords

primary care; cognitive behavioral therapy; clinical trial; feasibility-pilot study

Outcome Measures

Primary Outcomes (1)

• Acceptability of the training of PCPs

  Satisfaction with training content and its ability to provide sufficient training measured though 2 nominal groups with a previous script

  3 months postintervention

Secondary Outcomes (4)

• Feasibility of the intervention

  3 months postintervention

• Feasibility of the study design

  3 months postintervention

• Intervention Effectiveness: Sleep

  pretreatment and 3 months postintervention

• Intervention Effectiveness:Anxiety

  pretreatment and 3 months postintervention

Study Arms (2)

Cognitive behavioral therapy (CBT)

EXPERIMENTAL

5 sessions of Cognitive behavioral therapy for insmonia and an extra session for benzodiazepine withdrawal (if necessary). The CBT-i included sleep hygiene counseling, stimulus control, cognitive restructuring, relaxation techniques, and benzodiazepine therapy or withdrawal

Behavioral: Cognitive behavioral therapy for insomnia

Usual care

NO INTERVENTION

Usual care from GPs or nurses

Interventions

Cognitive behavioral therapy for insomnia BEHAVIORAL

is a multicomponent intervention which focuses on cognitive and behavioral factors that contribute to sleep disorders , The CBT-i included sleep hygiene counseling, stimulus control, cognitive restructuring, relaxation techniques, and benzodiazepine therapy or withdrawal (when needed). To conduct the intervention, guidelines for GPs and nurses and graphic and written materials for patients (sleep diary, registry of behavior habits, and cognitive problems) were developed

Cognitive behavioral therapy (CBT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years-old
• Diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI equal or higher than 8) and had insomnia longer than 3 months;
• Did or did not use a hypnotic medication.

You may not qualify if:

• Clinical diagnosis of secondary insomnia or another sleep disorder, such as restless legs syndrome, parasomnia, or alterations of the circadian rhythm (e.g., due to shift work)
• Use of a medication that could produce sleep alterations
• Severe psychiatric disorder; depression (HADS score ≥ 8) or diagnosis of major depression in the clinical records
• Suicide attempt
• Use of an antidepressant or anti-psychotic medication
• Alcohol or drug abuse during the last year
• Reception of another CBT-i
• Sleep apnea
• Dementia or presence of a cognitive deficit (Mini Mental State Evaluation score lower than 23)
• Neurodegenerative or oncological disease with poor prognosis
• Mental or physical incapacities that impeded participation in interviews
• Acute or chronic pain secondary to a rheumatic disease or another untreated chronic disease
• Pregnancy
• Participation in a previous clinical trial in the participating health centers

Sponsors & Collaborators

• Balearic Islands Health Service (Ibsalut): lead

Related Publications (1)

• Torrens I, Esteva M, Vicens C, Piza-Portell MR, Vidal-Thomas MC, Vidal-Ribas C, Lorente-Montalvo P, Torres-Solera E. Assessing the feasibility and acceptability of a cluster-randomized study of cognitive behavioral therapy for chronic insomnia in a primary care setting. BMC Fam Pract. 2021 Apr 16;22(1):77. doi: 10.1186/s12875-021-01429-5.

  PMID: 33863276 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Isabel Torrens, MD

  Santa Ponça health Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 25, 2020
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share