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

Not Applicable

• Conditions: Insomnia
• Interventions: Behavioral: Cognitive Behavior Therapy; Behavioral: Mindfulness-Based Cognitive Therapy

• Registration Number: NCT04134949
• Lead Sponsor: Qazvin University Of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-19
• Study First Submitted QC: 2019-10-21
• Last Update Submitted: 2019-10-21
• Study First Posted: 2019-10-22
• Last Update Posted: 2019-10-22
• Study Start: 2019-10-25
• Primary Completion: 2019-12-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT	Cognitive Behavior Therapy	consists of eight weekly treatment sessions of 45 to 60 minutes.
MCBT	Mindfulness-Based Cognitive Therapy	consists of eight weekly treatment sessions of 45 to 60 minutes.

Primary Outcome Measures

Name	Time	Method
sleep hygiene behavior	changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up	A self reported measure will be used with three items to measure how many days the participants had good sleep hygiene behavior.
Sleep Logs	changes in Sleep Logs , 1 month and 6 months follow-up	Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.
Sleep Quality	changes in sleep quality baseline , 1 month and 6 months follow-up	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	changes in insomnia baseline , 1 month and 6 months follow-up	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

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS)	changes in PSS, 1 month and 6 months follow-up	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.
Hospital Anxiety and Depression Scale (HADS)	changes in HADS, 1 month and 6 months follow-up	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.
Mindful Attention Awareness Scale	changes in MAAS, 1 month and 6 months follow-up	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	changes in GHQ-12, 1 month and 6 months follow-up	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

Trial Locations

Locations (2)

Qazvin University of Medical Sciences; 🇮🇷 Qazvin, Iran, Islamic Republic of

Social Determinants of Health Research Center; 🇮🇷 Qazvin, Iran, Islamic Republic of