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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04134949
• Other study ID #: IR.QUMS.REC.1397.294
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: October 2019
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: April 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavior Therapy
consists of eight weekly treatment sessions of 45 to 60 minutes.
• Mindfulness-Based Cognitive Therapy
consists of eight weekly treatment sessions of 45 to 60 minutes.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Qazvin University of Medical Sciences	Qazvin
Iran, Islamic Republic of	Social Determinants of Health Research Center	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	changes in HADS, 1 month and 6 months follow-up
Secondary	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.	changes in PSS, 1 month and 6 months follow-up
Secondary	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.	changes in MAAS, 1 month and 6 months follow-up
Secondary	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	changes in GHQ-12, 1 month and 6 months follow-up