Inflammation Clinical Trial
Official title:
Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial
Verified date | October 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to test the feasibility and efficacy of Internet-delivered Cognitive Behavioral Therapy (CBT) for adolescents (13 - 17 years) with sleep problems (ICBT-I). All participants will receive ICBT-I for six weeks. The investigators will also evaluate the effect of the intervention on comorbid psychiatric symptoms and function.
Status | Completed |
Enrollment | 27 |
Est. completion date | July 1, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | Inclusion Criteria: - Clinical levels of insomnia symptoms, as determined by ISI-a >10. - Age between 13 and 17 years - Ability to read and write Swedish - Daily access to the internet through a computer or similar device - Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment Exclusion Criteria: - Diagnosed with autism spectrum disorder, psychosis or bipolar disorder - Present risk of suicide - Ongoing substance dependence - Completed CBT for sleep disorders within the last 6 months (defined as at least 5 sessions of CBT - Ongoing use of central nervous system stimulant medication |
Country | Name | City | State |
---|---|---|---|
Sweden | BUP KFE | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Stockholm County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in insomnia symptom severity | Insomnia Severity Index- adolescent version ISI is a seven-item measure that yields a quantitative index of sleep impairment and treatment outcome. Total scores range from 0 to 28, with higher scores indicating greater perceived insomnia severity. The instrument has been adapted to teenagers, ISI-a, and validated on Swedish teenagers. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in subjective total sleep time | Measured with Sleep Wake Diary (SWD). The SWD is a subjective measure of participants' sleeping and waking times, from which total sleep time expressed in minutes is derived. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in subjective sleep onset latency | Measured with Sleep Wake Diary (SWD). The SWD is a subjective measure of participants' sleeping and waking times from which latency until falling asleep, expressed in minutes, is obtained. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in subjective wake after sleep onset | Measured with Sleep Wake Diary (SWD). The SWD is a subjective measure of participants' sleeping and waking times in which time awake expressed in minutes after sleep onset is obtained. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in subjective sleep efficiency | Measured with Sleep Wake Diary (SWD). The SWD is a subjective measure of participants' sleeping and waking times, from which sleep efficency is computed as the quota between time sleeping/time spent in bed, expressed in percentage. A higher percentage denotes longer time asleep. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in objective sleep total sleep time | Measured with wrist worn actigraph units. The actigraph unit will be worn during 7 consecutive days/nights at all three measurement occasion, from which total sleep time expressed in minutes is obtained. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in objective sleep onset latency | Measured with wrist worn actigraph units. The actigraph unit will be worn during 7 consecutive days/nights at all three measurement occasions, from which time in minutes before falling asleep is obtained. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in objective wake after sleep onset | Measured with wrist worn actigraph units. The actigraph unit will be worn during 7 consecutive days/nights at all three measurement occasions from which time being awake after sleep onset is obtained. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in objective sleep efficiency | Measured with wrist worn actigraph units. The actigraph unit will be worn during 7 consecutive days/nights at all three measurement occasions, from which sleep efficency is computed as the quota between time sleeping/time spent in bed, expressed in percentage. A higher percentage denotes longer time asleep. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in symptoms of insomnia | Measured with Athens Insomnia Scale (AIS), a self-administered questionnaire consisting of eight items to measure symptoms of insomnia. Total scores range from 0 to 24. Higher scores indicate that responders more severe insomnia symptoms. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in symptoms of depression | Measured with Center for Epidemiological Studies Depression Scale for Children (CES-DC). CES-DS is a 20-item self-report depression inventory that is widely used in research and has been validated on children and adolescents. Scores range from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in symptoms of depression 2 | Revised Children's Anxiety and Depression Scale Child and Parent version (RCADS-C/P). RCADS-C/P is a child and parent self-report measure of anxiety and depression related psychopathology. The 48 items of the RCADS measures five domains of anxiety: generalized anxiety, panic anxiety, separation anxiety, social anxiety and obsessive-compulsive anxiety, as well as symptoms of depression. For depression, values range from 0 to 30, with higher values denoting more depressive symptoms. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in symptoms of generalized anxiety | Measured with RCADS-C/P (see above). RCADS-C/P is a child and parent self-report measure of anxiety and depression related psychopathology. The 48 items of the RCADS measures five domains of anxiety: generalized anxiety, panic anxiety, separation anxiety, social anxiety and obsessive-compulsive anxiety, as well as symptoms of depression. For generalized anxiety, scores range from 0 to 18, with higher values denoting more severe symptoms of anxiety. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in difficulties in emotion regulation | Measured with Difficulties in Emotion Regulation Scale, short version (DERS-16), a self-rated questionnaire assessing difficulties to regulate emotion. DERS-16 can range from 16 to 80, with Higher scores reflect greater impairment. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in intensity of pain | A Visual Analogue Scale (VAS) will be used to measure intensity of participants' current and past pain.
The scale consists of a line where the ends are defined as extreme limits (0 = no pain; 10 = worst possible pain) of pain experience |
Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in daytime functioning | Measured with Functional Disability Inventory (FDI), a 15-item self-rated questionnaire to measure level of day-time functioning. Scores range from 0 (no disability) to 60 (severe disability). | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in daytime sleepiness 1 | Measured with Pediatric Daytime Sleepiness Scale (PDSS), a self-report scale consisting of 8 items. Scores range from 0-32, with higher scores indicating more daytime sleepiness. | Change from before treatment to after (+6 weeks) and to 6 month after treatment | |
Secondary | Change in daytime sleepiness 2 | Measured with the Karolinska Sleepiness Scale (KSS), a 9-point Likert scale, ranging from 1 to 9, with higher numbers denoting more sleepiness. | Change from before treatment to after (+6 weeks) and to 6 month after treatment |
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