Insomnia ChronicNCT04565223
Feasibility and Acceptability of Cognitive Behavioral Therapy for Chronic Insomnia in a Primary Care
A study testing Cognitive behavioral therapy for insomnia in people with Insomnia Chronic, run by Balearic Islands Health Service (Ibsalut).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Cognitive behavioral therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 1 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: 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.
Read the detailed description
Objectives
The primary objectives of this pilot-feasibility study were:
- 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.
- To define usual care (UC) for the treatment of chronic insomnia provided by PCPs as a comparative intervention (control group).
- To assess the training activities for the CBT-i intervention by determining GPs' and nurses' satisfaction with the content and applicability of the intervention.
- To determine the acceptability of the intervention by GPs and nurses.
- 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
- Conditions
- Insomnia Chronic
- Being tested
- Cognitive behavioral therapy for insomnia
- Keywords
- primary care, cognitive behavioral therapy, clinical trial, feasibility-pilot study
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for insomniaBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Cognitive behavioral therapy for insomnia |
| Usual care | No intervention | Usual care from GPs or nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months postintervention
Secondary outcomes (4)
Feasibility of the intervention
Adequacy of sessions in terms of content, duration and number, fitting in PCPs agenda and patients acceptance.
Measured: 3 months postintervention
Feasibility of the study design
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.
Measured: 3 months postintervention
Intervention Effectiveness: Sleep
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.
Measured: pretreatment and 3 months postintervention
Intervention Effectiveness:Anxiety
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
Measured: pretreatment and 3 months postintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Sep 2014
- Primary completion1 Apr 2015
- Study completion1 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balearic Islands Health Service (Ibsalut)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Torrens, Balearic Islands Health Service (Ibsalut)
- Investigators
- Isabel Torrens, MD, Principal investigator, Santa Ponça health Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565223
- Sponsor's protocol ID
- PI14/019
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data not shared
Publications
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.
PubMed 33863276
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asessing the Feasibility and Acceptability of a Cluster Randomized Study of Cognitive Behavioral Therapy for Chronic Insomnia in a Primary Care.
- ClinicalTrials.gov ID
- NCT04565223
- Acronym / sponsor ID
- PI14/019
- Conditions
- Insomnia Chronic
- Keywords
- primary care, cognitive behavioral therapy, clinical trial, feasibility-pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Balearic Islands Health Service (Ibsalut)University, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives
The primary objectives of this pilot-feasibility study were:
- 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.
- To define usual care (UC) for the treatment of chronic insomnia provided by PCPs as a comparative intervention (control group).
- To assess the training activities for the CBT-i intervention by determining GPs' and nurses' satisfaction with the content and applicability of the intervention.
- To determine the acceptability of the intervention by GPs and nurses.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy (CBT) | Experimental | Behavioral: Cognitive behavioral therapy for insomnia5 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 |
| Usual care | No intervention | –Usual care from GPs or nurses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy for insomniais 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 | Behavioural | Cognitive behavioral therapy (CBT) |
Primary outcome
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
4 secondary outcomes
Feasibility of the intervention
Time frame: 3 months postintervention
Feasibility of the study design
Time frame: 3 months postintervention
Intervention Effectiveness: Sleep
Time frame: pretreatment and 3 months postintervention
Intervention Effectiveness:Anxiety
Time frame: pretreatment and 3 months postintervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Derived from this study: PubMed 33863276Torrens 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.
- Individual participant dataSharing planned: No. Data not shared
Related trials for Insomnia Chronic
Not yet recruitingPhase 2
A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
Chronic Insomnia
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
Active, not recruiting
Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
Insomnia
Not yet recruiting
Effects of Connective Tissue Massage in Patients With Chronic Insomnia
Chronic Insomnia
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Torrens, MD principal investigator
Santa Ponça health Care Center
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for insomnia in people with Insomnia Chronic, run by Balearic Islands Health Service (Ibsalut).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the training of PCPs (time frame: 3 months postintervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04565223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.