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

Primary Purpose

Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Mindfulness-Based Cognitive Therapy
Sponsored by
Qazvin University Of Medical Sciences
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)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Qazvin University of Medical Sciences
  • Social Determinants of Health Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CBT

MCBT

Arm Description

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

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

Outcomes

Primary Outcome Measures

sleep hygiene behavior
A self reported measure will be used with three items to measure how many days the participants had good sleep hygiene behavior.
Sleep Quality
The Pittsburgh Sleep Quality Index includes seven components of subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, the use of sleep medications and day time dysfunctions provide a total score of these seven components that allows us to better understand the quality and quantity of one's sleep. The Pittsburgh Sleep Quality Index is a self-reporting instrument consisting of nine questions designed to measure the quality of sleep disorders in a period of one month. The scale scores range from 0 to 21, with higher scores indicating poor quality of sleep and scores less than 5 considered as high quality of sleep
Insomnia Severity Index
The Insomnia Severity Index is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes. The Insomnia Severity Index assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems. It was found to be a clinically useful tool in assessing changes in insomnia symptoms in insomnia treatment research.Higher scores reflecting more severe sleep problems
Sleep Logs
Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.

Secondary Outcome Measures

Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Perceived Stress Scale (PSS)
The Perceived Stress Scale is the most widely used measure of global perceived stress, and is a robust predictor of health and disease. The Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.
Mindful Attention Awareness Scale
The trait Mindful Attention Awareness Scale is a 15-item scale designed to assess a core characteristic of mindfulness. Higher scores on the Mindful Attention Awareness Scale are associated with fewer & less intense current unpleasant & negative emotional states.
psychological well-being
The General Health Questionnaire (GHQ-12) is a self-administered questionnaire to screen and detect individuals with a diagnosable psychiatric disorder. The higher the General Health Questionnaire scores, the greater the degree to which the subject may suffer from a psychiatric distress

Full Information

First Posted
October 19, 2019
Last Updated
October 21, 2019
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04134949
Brief Title
Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
Official Title
Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2019 (Anticipated)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Description
consists of eight weekly treatment sessions of 45 to 60 minutes.
Arm Title
MCBT
Arm Type
Experimental
Arm Description
consists of eight weekly treatment sessions of 45 to 60 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
consists of eight weekly treatment sessions of 45 to 60 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy
Intervention Description
consists of eight weekly treatment sessions of 45 to 60 minutes.
Primary Outcome Measure Information:
Title
sleep hygiene behavior
Description
A self reported measure will be used with three items to measure how many days the participants had good sleep hygiene behavior.
Time Frame
changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up
Title
Sleep Quality
Description
The Pittsburgh Sleep Quality Index includes seven components of subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, the use of sleep medications and day time dysfunctions provide a total score of these seven components that allows us to better understand the quality and quantity of one's sleep. The Pittsburgh Sleep Quality Index is a self-reporting instrument consisting of nine questions designed to measure the quality of sleep disorders in a period of one month. The scale scores range from 0 to 21, with higher scores indicating poor quality of sleep and scores less than 5 considered as high quality of sleep
Time Frame
changes in sleep quality baseline , 1 month and 6 months follow-up
Title
Insomnia Severity Index
Description
The Insomnia Severity Index is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes. The Insomnia Severity Index assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems. It was found to be a clinically useful tool in assessing changes in insomnia symptoms in insomnia treatment research.Higher scores reflecting more severe sleep problems
Time Frame
changes in insomnia baseline , 1 month and 6 months follow-up
Title
Sleep Logs
Description
Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.
Time Frame
changes in Sleep Logs , 1 month and 6 months follow-up
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Time Frame
changes in HADS, 1 month and 6 months follow-up
Title
Perceived Stress Scale (PSS)
Description
The Perceived Stress Scale is the most widely used measure of global perceived stress, and is a robust predictor of health and disease. The Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
changes in PSS, 1 month and 6 months follow-up
Title
Mindful Attention Awareness Scale
Description
The trait Mindful Attention Awareness Scale is a 15-item scale designed to assess a core characteristic of mindfulness. Higher scores on the Mindful Attention Awareness Scale are associated with fewer & less intense current unpleasant & negative emotional states.
Time Frame
changes in MAAS, 1 month and 6 months follow-up
Title
psychological well-being
Description
The General Health Questionnaire (GHQ-12) is a self-administered questionnaire to screen and detect individuals with a diagnosable psychiatric disorder. The higher the General Health Questionnaire scores, the greater the degree to which the subject may suffer from a psychiatric distress
Time Frame
changes in GHQ-12, 1 month and 6 months follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Qazvin University of Medical Sciences
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of
Facility Name
Social Determinants of Health Research Center
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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