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

D

David Batalla-Martin

Status

Completed

Conditions

Schizophrenia
Insomnia

Treatments

Behavioral: cognitive behavioural intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05115604
NBMH01/2021

Details and patient eligibility

About

The study aims to evaluate the efficacy of a cognitive behavioural and psychoeducational intervention in patients with insomnia and diagnosed with a schizophrenic disorder.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Intrervention group
Experimental group
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.
Treatment:
Behavioral: cognitive behavioural intervention
Control group
No Intervention group
Description:
routine clinical follow-up

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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