Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners

NCT ID: NCT04134949

Last Updated: 2019-10-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-25

Study Completion Date

2020-04-30

Brief Summary

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Insomnia is highly prevalent in prisoners and is a risk factor for poor mental well-being, depression, suicidality and aggression, all common concerns in this vulnerable population. Improving sleep management options in prison offers the potential to impact positively on a number of these common risk factors. The study aim is to asses psychological intervention for insomnia in prisons.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CBT

consists of eight weekly treatment sessions of 45 to 60 minutes.

Group Type EXPERIMENTAL

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

consists of eight weekly treatment sessions of 45 to 60 minutes.

MCBT

consists of eight weekly treatment sessions of 45 to 60 minutes.

Group Type EXPERIMENTAL

Mindfulness-Based Cognitive Therapy

Intervention Type BEHAVIORAL

consists of eight weekly treatment sessions of 45 to 60 minutes.

Interventions

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Cognitive Behavior Therapy

consists of eight weekly treatment sessions of 45 to 60 minutes.

Intervention Type BEHAVIORAL

Mindfulness-Based Cognitive Therapy

consists of eight weekly treatment sessions of 45 to 60 minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Are at least 18 years of age
* Clinical level of Insomnia (more than 10 on ISI)
* Meets criteria for Insomnia according to DSM-5 Insomnia Disorder
* Can speak, understand, and write in Persian
* Male

Exclusion Criteria

* Currently receiving psychological treatment for Insomnia
* presence of a rapidly progressing neurological or medical disorder
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Qazvin University Of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir H Pakpour

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qazvin University of Medical Sciences

Qazvin, , Iran

Site Status

Social Determinants of Health Research Center

Qazvin, , Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.QUMS.REC.1397.294

Identifier Type: -

Identifier Source: org_study_id

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