InsomniaNCT05115604
Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a CBT and Psychoeducational Intervention
A study testing cognitive behavioural intervention in people with Insomnia and Schizophrenia, run by David Batalla-Martin at 1 site in Spain.
Trial summary
The study aims to evaluate the efficacy of a cognitive behavioural and psychoeducational intervention in patients with insomnia and diagnosed with a schizophrenic disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Schizophrenia
- What is being tested?
- cognitive behavioural intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 8 Apr 2021to 9 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insomnia disorder (ISI scale)
- Schizophrenic disorder
Who cannot join
- Presence of severe psychopathological alteration
- Inability to understand the Spanish language or difficulties writing or reading
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a Cognitive Behavioural and Psychoeducational Intervention
The study aims to evaluate the efficacy of a cognitive behavioural and psychoeducational intervention in patients with insomnia and diagnosed with a schizophrenic disorder.
Read the detailed description
Patients will be recruited by consecutive non-probabilistic sampling at the Outpatient Mental Health Centre of Nou Barris in Barcelona and subsequently randomised into 2 groups, control and intervention. Presence and severity of insomnia will be assessed through the following measurement instruments: ISI for presence and severity, PSQI for sleep quality and EQ-5D for health-related quality of life. Patients in intervention will attend 6 group sessions with cognitive behavioural and psychoeducational intervention and the control group will carry out the usual follow-up. Pre-post, 6-month and 9-month assessments will be analysed.
- Conditions
- Insomnia, Schizophrenia
- Being tested
- cognitive behavioural intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioural interventionBehavioural
Six sessions of cognitive behavioural and psychoeducational therapy will be conducted to treat insomnia.
| Study group | Role | What they receive |
|---|---|---|
| Intrervention group | Experimental | One and a half hour sessions (6 sessions) of cognitive behavioural therapy and psychoeducation. The sessions will consist of: sleep hygiene, cognitive therapy, bedtime restriction, stimulus control and relaxation. Receives: Behavioral: cognitive behavioural intervention |
| Control group | No intervention | routine clinical follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the severity of insomnia, mesured with the Spanish version of the Insomnia Severity Insomnia
Insomnia severity was assessed using the Insomnia Severity Index (ISI) (Morin, 1993), a self-applied instrument designed to briefly assess the severity of insomnia in the general population based on the diagnostic criteria of the DSM-IV and the ICSD. A 5-point Likert scale is used to rate each item (0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: not clinically significant insomnia (0-7); subthreshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28) This scale has been found to have adequate psychometric properties in studies conducted using English version (Bastien et al, 2001), with internal reliability values (Cronbach's a) between 0.74 and 0.90, and test-retest reliability equal to 0.89 one month after evaluation, 0.77 two months after, and 0.73 three months after. Two validation studies of the Spanish version of the ISI (Fernandez-Mendoza et al., 2012; Sierra et al, 2008)
Measured: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
Change in the quality of sleep, mesured with the Spanish version of The Pittsburgh Sleep Quality Index
The quality of sleep has been analysed by The Pittsburgh Sleep Quality Index, which is made up of 19 self-administered questions. The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. These I9 items are grouped into seven component scores, each weighted equally on a O-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality (Buysse et al. 1989) . This tool has shown in its English version acceptable measures of internal homogeneity, consistency, and validity were obtained. A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% in distinguishing good and poor sleepers (Buysse et al. 1989) Tool that has been adapted in its Spanish version (Macias Fernandez and Royuela Rico 1996)
Measured: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
Secondary outcomes (1)
Change in health-related quality of life , mesured with the Spanish version of EuroQol-5D Scale
Health-related quality of life (HRQoL) has been assessed using the EuroQol-5D Scale (EQ-5D) (EuroQol Group 1990) a self-applied scale that is quick and easy to administer, yielding a multidimensional description of general health as well as a numerical health profile. The scale is made up of two parts, the EQ-5D descriptive system, 5 dimensions (mobility, self- care, usual activities, pain/discomfort, and anxiety/de- pression), each with 3 levels of severity (value 1 = no problems, value 2 = some problems, value 3 = severe problems) and the visual analogue scale (EQ-VAS) (value 0 = worst and value 100 = best imaginable health status). This scale has been validated in Spain by Xavier Badia (Badia et al. 1999). For psychometric properties, the scale presented a test-retest reliability between 0.86 and 0.90 (van Agt et al. 1994) and a strong correlation with the SF-36 scale. The EQ-5D scale has also been shown to be valid for use with patients with schizophrenia (Prieto et al. 2004)
Measured: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start8 Apr 2021
- Primary completion20 Jul 2021
- Study completion9 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Batalla-Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Batalla-Martin, Nou Barris Mental Health Center
- Investigators
- David Batalla-Martin, RN, MSc, Principal investigator, Nou Barris Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115604
- Sponsor's protocol ID
- NBMH01/2021
- Status last verified
- Sep 2022
- First submitted
- 20 Oct 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a Cognitive Behavioural and Psychoeducational Intervention
- ClinicalTrials.gov ID
- NCT05115604
- Acronym / sponsor ID
- NBMH01/2021
- Conditions
- Insomnia, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- David Batalla-MartinUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 9 Jul 2022 (actual)
- First posted
- 10 Nov 2021 (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.
The study aims to evaluate the efficacy of a cognitive behavioural and psychoeducational intervention in patients with insomnia and diagnosed with a schizophrenic disorder.
Detailed description
Patients will be recruited by consecutive non-probabilistic sampling at the Outpatient Mental Health Centre of Nou Barris in Barcelona and subsequently randomised into 2 groups, control and intervention. Presence and severity of insomnia will be assessed through the following measurement instruments: ISI for presence and severity, PSQI for sleep quality and EQ-5D for health-related quality of life. Patients in intervention will attend 6 group sessions with cognitive behavioural and psychoeducational intervention and the control group will carry out the usual follow-up. Pre-post, 6-month and 9-month assessments will be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrervention group | Experimental | Behavioral: cognitive behavioural interventionOne and a half hour sessions (6 sessions) of cognitive behavioural therapy and psychoeducation. The sessions will consist of: sleep hygiene, cognitive therapy, bedtime restriction, stimulus control and relaxation. |
| Control group | No intervention | –routine clinical follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Insomnia disorder (ISI scale)
- Schizophrenic disorder
Key exclusion criteria (2 listed)
- Presence of severe psychopathological alteration
- Inability to understand the Spanish language or difficulties writing or reading
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 behavioural interventionSix sessions of cognitive behavioural and psychoeducational therapy will be conducted to treat insomnia. | Behavioural | Intrervention group |
Primary outcome
Change in the severity of insomnia, mesured with the Spanish version of the Insomnia Severity Insomnia
Time frame: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
Insomnia severity was assessed using the Insomnia Severity Index (ISI) (Morin, 1993), a self-applied instrument designed to briefly assess the severity of insomnia in the general population based on the diagnostic criteria of the DSM-IV and the ICSD. A 5-point Likert scale is used to rate each item (0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: not clinically significant insomnia (0-7); subthreshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28) This scale has been found to have adequate psychometric properties in studies conducted using English version (Bastien et al, 2001), with internal reliability values (Cronbach's a) between 0.74 and 0.90, and test-retest reliability equal to 0.89 one month after evaluation, 0.77 two months after, and 0.73 three months after. Two validation studies of the Spanish version of the ISI (Fernandez-Mendoza et al., 2012; Sierra et al, 2008)
Change in the quality of sleep, mesured with the Spanish version of The Pittsburgh Sleep Quality Index
Time frame: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
The quality of sleep has been analysed by The Pittsburgh Sleep Quality Index, which is made up of 19 self-administered questions. The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. These I9 items are grouped into seven component scores, each weighted equally on a O-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality (Buysse et al. 1989) . This tool has shown in its English version acceptable measures of internal homogeneity, consistency, and validity were obtained. A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% in distinguishing good and poor sleepers (Buysse et al. 1989) Tool that has been adapted in its Spanish version (Macias Fernandez and Royuela Rico 1996)
1 secondary outcome
Change in health-related quality of life , mesured with the Spanish version of EuroQol-5D Scale
Time frame: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
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 28 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
David Batalla-Martin, RN, MSc principal investigator
Nou Barris Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioural intervention in people with Insomnia and Schizophrenia, run by David Batalla-Martin at 1 site in Spain.
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 2 inclusion and 2 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in the severity of insomnia, mesured with the Spanish version of the Insomnia Severity Insomnia (time frame: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2022.