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

September 21, 2020 updated by: Isabel Torrens, Balearic Islands Health Service (Ibsalut)

Asessing the Feasibility and Acceptability of a Cluster Randomized Study of Cognitive Behavioral Therapy for Chronic Insomnia in a Primary Care.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objectives

The primary objectives of this pilot-feasibility study were:

  1. To design and adapt a brief CBT-i intervention to be provided by PCPs for the treatment of chronic insomnia in individuals who are 18 to 65 years-old.
  2. To define usual care (UC) for the treatment of chronic insomnia provided by PCPs as a comparative intervention (control group).
  3. To assess the training activities for the CBT-i intervention by determining GPs' and nurses' satisfaction with the content and applicability of the intervention.
  4. To determine the acceptability of the intervention by GPs and nurses.
  5. To assess PCPs and patient recruitment, follow-up, and adherence to the intervention The secondary objective was to assess the quality of sleep in patients after 3 months of the CBT-i.

Methods Design This pilot-feasibility study of a cluster parallel randomized design comparing CBT-I against usual care (UC) was performed from September 2014 to April 2015 at two primary health care centers of Majorca (Spain) with 56,000 registered inhabitants.

Collection of information and follow up Intervention The CBT-i intervention was developed by two family physicians (IT and CV) and two psychologists (ET and MRP-P). First, a review of the literature on the use of CBT-i was performed, with a focus on interventions applied in primary care. After the literature review, the CBT-i created by Morin [24] was adapted to our setting, in which there were fewer sessions and shorter sessions. 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.

Usual care The usual treatment for persistent insomnia in a primary care setting was previously described in two cross-sectional studies performed by general practitioners and family nurses of the Primary Care Majorca Department during 2011 and 2015

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 18 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.

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive behavioral therapy (CBT)

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
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
No Intervention: Usual care
Usual care from GPs or nurses

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of the training of PCPs
Time Frame: 3 months postintervention
Satisfaction with training content and its ability to provide sufficient training measured though 2 nominal groups with a previous script
3 months postintervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of the intervention
Time Frame: 3 months postintervention
Adequacy of sessions in terms of content, duration and number, fitting in PCPs agenda and patients acceptance.
3 months postintervention
Feasibility of the study design
Time Frame: 3 months postintervention
Number of patients eligible identified and included, number of PCP randomized, number of patients followed up,completion of follow up and adherence to intervention sessions.
3 months postintervention
Intervention Effectiveness: Sleep
Time Frame: pretreatment and 3 months postintervention
The Pittsburgh Sleep Quality Index (PSQI) is a 19-items self reported questionnaire that assesses 7 clinical components of sleep quality. Each item is rated on 0 to 3 point scale in which 0 is equal to not in the past month and 3 is equal to 3 or more times a week, with a global score range from 0 to 21. A cut off score of 5 has shown to discriminate between good and bad sleepers.
pretreatment and 3 months postintervention
Intervention Effectiveness:Anxiety
Time Frame: pretreatment and 3 months postintervention
The Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression levels in the preceding week. It is 14-item self-report scale with two 7-item anxiety or depression subscales. Each item scores from 0 to 3 point scale giving maximum subscale scores of 21. Patients with scores >10 are considered to have morbidity, between 8 and 10 as borderline cases and <8 absence of relevant
pretreatment and 3 months postintervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balearic Islands Health Service (Ibsalut)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabel Torrens, MD, Santa Ponça health Care Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI14/019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data not shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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