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

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.

Study Overview

• Status: Unknown
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavior Therapy; Behavioral: Mindfulness-Based Cognitive Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Qazvin, Iran, Islamic Republic of, 3419759811
    • Qazvin University of Medical Sciences
  • Qazvin, Iran, Islamic Republic of, 3419759811
    • Social Determinants of Health Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT; consists of eight weekly treatment sessions of 45 to 60 minutes.	Behavioral: Cognitive Behavior Therapy; consists of eight weekly treatment sessions of 45 to 60 minutes.
Experimental: MCBT; consists of eight weekly treatment sessions of 45 to 60 minutes.	Behavioral: Mindfulness-Based Cognitive Therapy; consists of eight weekly treatment sessions of 45 to 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): October 25, 2019
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: October 19, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IR.QUMS.REC.1397.294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No