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

NCT05115604 | Completed

• 1 other identifier: NBMH01/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  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

  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)

Study Arms (2)

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.

Behavioral: cognitive behavioural intervention

Control group

NO INTERVENTION

routine clinical follow-up

Interventions

cognitive behavioural intervention BEHAVIORAL

Six sessions of cognitive behavioural and psychoeducational therapy will be conducted to treat insomnia.

Intrervention group

Eligibility Criteria

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

You may qualify if:

• Insomnia disorder (ISI scale)
• Schizophrenic disorder

You may not qualify if:

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

Sponsors & Collaborators

• David Batalla-Martin: lead

Study Sites (1)

Nou Barris Mental Health Center

Barcelona, Catalonia, 08027, Spain

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• David Batalla-Martin, RN, MSc

  Nou Barris Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 10, 2021
• Study Start: April 8, 2021
• Primary Completion: July 20, 2021
• Study Completion: July 9, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

ES (1)