InsomniaNCT04134949
Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
A study testing Cognitive Behavior Therapy and Mindfulness-Based Cognitive Therapy in people with Insomnia, run by Qazvin University Of Medical Sciences at 2 sites in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavior Therapy and Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesIran
- Study dates
- 25 Oct 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently receiving psychological treatment for Insomnia
- presence of a rapidly progressing neurological or medical disorder
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Qazvin University of Medical Sciences
Qazvin, 3419759811
Social Determinants of Health Research Center
Qazvin, 3419759811
About this study
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.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavior Therapy, Mindfulness-Based Cognitive Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
consists of eight weekly treatment sessions of 45 to 60 minutes.
Mindfulness-Based Cognitive TherapyBehavioural
consists of eight weekly treatment sessions of 45 to 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | consists of eight weekly treatment sessions of 45 to 60 minutes. Receives: Behavioral: Cognitive Behavior Therapy |
| MCBT | Experimental | consists of eight weekly treatment sessions of 45 to 60 minutes. Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: changes in Sleep Logs , 1 month and 6 months follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: changes in GHQ-12, 1 month and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start25 Oct 2019 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134949
- Sponsor's protocol ID
- IR.QUMS.REC.1397.294
- Status last verified
- Oct 2019
- First submitted
- 19 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
- ClinicalTrials.gov ID
- NCT04134949
- Acronym / sponsor ID
- IR.QUMS.REC.1397.294
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- 25 Oct 2019 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive Behavior Therapyconsists of eight weekly treatment sessions of 45 to 60 minutes. |
| MCBT | Experimental | Behavioral: Mindfulness-Based Cognitive Therapyconsists of eight weekly treatment sessions of 45 to 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Currently receiving psychological treatment for Insomnia
- presence of a rapidly progressing neurological or medical disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapyconsists of eight weekly treatment sessions of 45 to 60 minutes. | Behavioural | CBT |
| Mindfulness-Based Cognitive Therapyconsists of eight weekly treatment sessions of 45 to 60 minutes. | Behavioural | MCBT |
Primary outcome
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.
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
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
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.
4 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: changes in HADS, 1 month and 6 months follow-up
Perceived Stress Scale (PSS)
Time frame: changes in PSS, 1 month and 6 months follow-up
Mindful Attention Awareness Scale
Time frame: changes in MAAS, 1 month and 6 months follow-up
psychological well-being
Time frame: changes in GHQ-12, 1 month and 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy and Mindfulness-Based Cognitive Therapy in people with Insomnia, run by Qazvin University Of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep hygiene behavior (time frame: changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.