Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
1 other identifier
interventional
140
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedStudy Start
First participant enrolled
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedOctober 22, 2019
October 1, 2019
2 months
October 19, 2019
October 21, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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.
changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up
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
changes in sleep quality baseline , 1 month and 6 months follow-up
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
changes in insomnia baseline , 1 month and 6 months follow-up
Sleep Logs
Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.
changes in Sleep Logs , 1 month and 6 months follow-up
Secondary Outcomes (4)
Hospital Anxiety and Depression Scale (HADS)
changes in HADS, 1 month and 6 months follow-up
Perceived Stress Scale (PSS)
changes in PSS, 1 month and 6 months follow-up
Mindful Attention Awareness Scale
changes in MAAS, 1 month and 6 months follow-up
psychological well-being
changes in GHQ-12, 1 month and 6 months follow-up
Study Arms (2)
CBT
EXPERIMENTALconsists of eight weekly treatment sessions of 45 to 60 minutes.
MCBT
EXPERIMENTALconsists of eight weekly treatment sessions of 45 to 60 minutes.
Interventions
consists of eight weekly treatment sessions of 45 to 60 minutes.
consists of eight weekly treatment sessions of 45 to 60 minutes.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently receiving psychological treatment for Insomnia
- presence of a rapidly progressing neurological or medical disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Qazvin University of Medical Sciences
Qazvin, 3419759811, Iran
Social Determinants of Health Research Center
Qazvin, 3419759811, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 19, 2019
First Posted
October 22, 2019
Study Start
October 25, 2019
Primary Completion
December 30, 2019
Study Completion
April 30, 2020
Last Updated
October 22, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF