Clinical Trials Logo

Clinical Trial Summary

Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The most common and best documented treatment for insomnia is cognitive behavioral therapy for insomnia (CBTi). There is a great gap in the knowledge on how sleep disorders can be treated effectively in psychiatric care. In this project the investigators therefore seek to investigate the effect of non-pharmacological, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures. CBTi comprise of sleep education, sleep restriction, stimulus control and cognitive restructuring of dysfunctional thoughts about sleep.


Clinical Trial Description

The recommended treatment for insomnia is CBTi. Recent research has proven that dark therapy, or blocking light in wavelengths <530 nm by the use of for example orange blue-blocking glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to darkness and to have an additive effect in the treatment of insomnia. The investigators therefore also want to test bb-glasses as an additive treatment to CBTi for insomnia. The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The insomnia-group gets together every other Monday from noon until 2 pm. The group is open, which means that participants start at different dates and meet people in the group that might be at the end of their CBTi treatment. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS. Participant have been referred to the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on the same structure for the group for participants that are recruited to the RCT. All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based CBTi treatment. In a randomized manner, they will be allocated to the sleep-school group and start the treatment on the next possible date or to a 8 week wait-list and receive a date the treatment starts. All eligible participants will be informed that there may be a waitlist and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for their psychiatric problems parallel to either sleep-school or waitlist. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based CBTi 8 weeks or b) group-based CBTi 8 weeks and bb-glasses. All participant will be followed up after 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04463498
Study type Interventional
Source Haukeland University Hospital
Contact Ane Wilhelmsen-Langeland, PhD
Phone +47 55957000
Email ane.wilhelmsen-langeland@helse-bergen.no
Status Recruiting
Phase N/A
Start date December 17, 2021
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT00166764 - A Study on Evaluation of Mental Health Index of Patients With Psychiatric Disorders N/A
Recruiting NCT06062953 - Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia Phase 2/Phase 3
Recruiting NCT05548946 - A Dimensional Model for Personality Disorders in Later Life N/A
Completed NCT03313154 - Impact on QoL and Cognitive Functioning of New Antiviral Therapies in Subjects With Chronic Hepatitis HCV-related
Completed NCT00783783 - CYP2D6 Pharmacogenetics in Risperidone-Treated Children N/A
Completed NCT01989728 - Prevalence and Effect of Detecting Common Mental Disorders in Long-term Sickness Absence N/A
Completed NCT03125083 - Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus N/A
Recruiting NCT01066299 - Influence of Oxytocin on the Startle Reflex and on Its Modulation N/A
Completed NCT02987426 - Can Brief-mindfulness Interventions Improve Psychiatric Symptoms? Phase 2/Phase 3
Recruiting NCT05784818 - Up To Me: Erasing the Stigma of Mental Illness on College Campuses N/A
Completed NCT01786733 - Behavioral Activation - From Inpatient to Outpatient Services N/A
Withdrawn NCT03907124 - Clinical Utility of Pharmacogenomics of Psychotropic Medications Phase 4
Withdrawn NCT03809897 - Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders Phase 4
Not yet recruiting NCT02857322 - Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative N/A
Terminated NCT02665988 - Adjunctive Transcranial Direct Current Stimulation N/A
Completed NCT01823250 - Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial Phase 2
Completed NCT01289080 - Trial Evaluating OPC-34712 in Subjects With Normal Renal Function and Renally Impaired Subjects Phase 1
Active, not recruiting NCT00982943 - The Epidemiological Study on Psychiatric Disorders and Psychotropic Drugs N/A
Completed NCT00184340 - Secured Internet-mediated Psychotherapy With Psychiatry Patients N/A
Completed NCT00184327 - Changes Following Inpatient Child-oriented Family Treatment Phase 1