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

NCT ID: NCT05115604

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-08

Study Completion Date

2022-07-09

Brief Summary

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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

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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

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Insomnia Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intrervention group

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.

Group Type EXPERIMENTAL

cognitive behavioural intervention

Intervention Type BEHAVIORAL

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

Control group

routine clinical follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cognitive behavioural intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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David Batalla-Martin

OTHER

Sponsor Role lead

Responsible Party

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David Batalla-Martin

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Batalla-Martin, RN, MSc

Role: PRINCIPAL_INVESTIGATOR

Nou Barris Mental Health

Locations

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Nou Barris Mental Health Center

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

Other Identifiers

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NBMH01/2021

Identifier Type: -

Identifier Source: org_study_id

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