Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134949
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Amir H Pakpour, 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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Cognitive Behavior Therapy Behavioral: Mindfulness-Based Cognitive Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
Estimated Study Start Date : October 25, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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.




Primary Outcome Measures :
  1. sleep hygiene behavior [ Time Frame: 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.

  2. Sleep Quality [ Time Frame: 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

  3. Insomnia Severity Index [ Time Frame: 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

  4. Sleep Logs [ Time Frame: 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.


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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.

  2. Perceived Stress Scale (PSS) [ Time Frame: 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.

  3. Mindful Attention Awareness Scale [ Time Frame: 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.

  4. psychological well-being [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134949


Locations
Layout table for location information
Iran, Islamic Republic of
Qazvin University of Medical Sciences
Qazvin, Iran, Islamic Republic of, 3419759811
Social Determinants of Health Research Center
Qazvin, Iran, Islamic Republic of, 3419759811
Sponsors and Collaborators
Qazvin University Of Medical Sciences
Layout table for additonal information
Responsible Party: Amir H Pakpour, Associate Professor, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT04134949    
Other Study ID Numbers: IR.QUMS.REC.1397.294
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders