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Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a CBT and Psychoeducational Intervention

Primary Purpose

Insomnia, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
cognitive behavioural intervention
Sponsored by
David Batalla-Martin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Insomnia disorder (ISI scale)
  • Schizophrenic disorder

Exclusion Criteria:

  • Presence of severe psychopathological alteration
  • Inability to understand the Spanish language or difficulties writing or reading

Sites / Locations

  • Nou Barris Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intrervention group

Control group

Arm Description

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.

routine clinical follow-up

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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)

Full Information

First Posted
October 20, 2021
Last Updated
September 27, 2022
Sponsor
David Batalla-Martin
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1. Study Identification

Unique Protocol Identification Number
NCT05115604
Brief Title
Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a CBT and Psychoeducational Intervention
Official Title
Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a Cognitive Behavioural and Psychoeducational Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
July 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Batalla-Martin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
routine clinical follow-up
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioural intervention
Intervention Description
Six sessions of cognitive behavioural and psychoeducational therapy will be conducted to treat insomnia.
Primary Outcome Measure Information:
Title
Change in the severity of insomnia, mesured with the Spanish version of the Insomnia Severity Insomnia
Description
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)
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)
Title
Change in the quality of sleep, mesured with the Spanish version of The Pittsburgh Sleep Quality Index
Description
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)
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)
Secondary Outcome Measure Information:
Title
Change in health-related quality of life , mesured with the Spanish version of EuroQol-5D Scale
Description
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Insomnia disorder (ISI scale) Schizophrenic disorder Exclusion Criteria: Presence of severe psychopathological alteration Inability to understand the Spanish language or difficulties writing or reading
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Batalla-Martin, RN, MSc
Organizational Affiliation
Nou Barris Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nou Barris Mental Health Center
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08027
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a CBT and Psychoeducational Intervention

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