Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616157
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2018-04-05
Brief Title:
Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PARTICIPANT RECRUITMENT
For recruitment this pilot trial will be advertised at child and adolescent mental health services and primary care clinics as well as through newspapers The inclusion procedure will be carried out in two steps 1 telephone interview and 2 face-to-face assessment
Telephone interview An initial telephone interview will be conducted with the adolescentparent in order to broadly assess inclusion and exclusion criteria
Face-to-face baseline diagnostic assessment After the telephone screening the adolescent along with hisher parents are invited to a face-to-face assessment at the Child and Adolescent Mental Health clinic including the diagnostic screening interview MINI-KID conducted with adolescents and parents jointly Insomnia diagnoses will be established using DSM-IV criteria and levels of insomnia symptoms will be determined using ISI-a If the ISI-a score is 10 the family will be invited to participate in the study provided that the other inclusion criteria are fulfilled and no exclusion criteria prohibit participation Following face-to-face assessment participants will be provided with an information sheet and consent form
DATA COLLECTION
Baseline self-report measures Participants included in the study after the face-to-face diagnostic assessment are asked to fill in self-report measures on the internet provided via personal login and password Participants will aslo be asked to fill in a sleep-wake diary and to wear an actigraph during seven consecutive daysnights
Self-rating assessments during intervention ISI-a is administered to adolescents every week during treatment
Study participants are in regular contact on a weekly basis with experienced clinicians during the ICBT-I treatment Clinicians that suspect any kind of adverse event during the assessment or treatment process will contact the parent via telephone as a first step of assessing the severity of the incident Adverse events in this context are defined as an actual or potential situation that threatens the patients well-being eg suicide risk or an acute increase of symptoms In the case of an adverse event the clinician informs the study coordinator LÅ for a discussion of adequate action taking If a continuation of the ICBT treatment is considered inappropriate with regard to the participants best interest and well-being the participant will be excluded from the study and parentsadolescents will be provided with proper referral information Any adverse event will be reported in the planned publication of the pilot study
Outcome measure reliability procedures To ensure the reliability of the assessments conducted by study clinicians all assessors will be trained by experienced instructors in the diagnostic screening instrument MINI-KID All therapists that participate in the study will also be continuously trained in MINI-KID interviewing assessment and diagnosing
Post-treatment and follow-up measurement Post-treatment measurement with actigraphy sleep-wake diary and self-report measures will be conducted immediately after treatment 6 weeks after baseline A follow-up measurement will be performed 6 months after treatment termination
Referral of non-responders After the 6-month follow-up all non-responders defined as those participants who have not improved to a clinically meaningful degree according to ISI-a will be referred to their local child-and adolescent psychiatric clinic for further treatment
Statistical Analyses Outcomes will be described as significant changes in objective and subjective sleep and in clinician and self-rated measures of insomnia symptoms and comorbid symptoms within-group effect sizes Cohens d clinically significant improvement rates and remission rates Analyses will involve t-tests as well as linear mixed-effects modeling Randomness of missing data will be analyzed with logistic regression Depending on the amount of missing data multiple imputations will be employed to compensate for missing values
For recruitment this pilot trial will be advertised at child and adolescent mental health services and primary care clinics as well as through newspapers The inclusion procedure will be carried out in two steps 1 telephone interview and 2 face-to-face assessment
Telephone interview An initial telephone interview will be conducted with the adolescentparent in order to broadly assess inclusion and exclusion criteria
Face-to-face baseline diagnostic assessment After the telephone screening the adolescent along with hisher parents are invited to a face-to-face assessment at the Child and Adolescent Mental Health clinic including the diagnostic screening interview MINI-KID conducted with adolescents and parents jointly Insomnia diagnoses will be established using DSM-IV criteria and levels of insomnia symptoms will be determined using ISI-a If the ISI-a score is 10 the family will be invited to participate in the study provided that the other inclusion criteria are fulfilled and no exclusion criteria prohibit participation Following face-to-face assessment participants will be provided with an information sheet and consent form
DATA COLLECTION
Baseline self-report measures Participants included in the study after the face-to-face diagnostic assessment are asked to fill in self-report measures on the internet provided via personal login and password Participants will aslo be asked to fill in a sleep-wake diary and to wear an actigraph during seven consecutive daysnights
Self-rating assessments during intervention ISI-a is administered to adolescents every week during treatment
Study participants are in regular contact on a weekly basis with experienced clinicians during the ICBT-I treatment Clinicians that suspect any kind of adverse event during the assessment or treatment process will contact the parent via telephone as a first step of assessing the severity of the incident Adverse events in this context are defined as an actual or potential situation that threatens the patients well-being eg suicide risk or an acute increase of symptoms In the case of an adverse event the clinician informs the study coordinator LÅ for a discussion of adequate action taking If a continuation of the ICBT treatment is considered inappropriate with regard to the participants best interest and well-being the participant will be excluded from the study and parentsadolescents will be provided with proper referral information Any adverse event will be reported in the planned publication of the pilot study
Outcome measure reliability procedures To ensure the reliability of the assessments conducted by study clinicians all assessors will be trained by experienced instructors in the diagnostic screening instrument MINI-KID All therapists that participate in the study will also be continuously trained in MINI-KID interviewing assessment and diagnosing
Post-treatment and follow-up measurement Post-treatment measurement with actigraphy sleep-wake diary and self-report measures will be conducted immediately after treatment 6 weeks after baseline A follow-up measurement will be performed 6 months after treatment termination
Referral of non-responders After the 6-month follow-up all non-responders defined as those participants who have not improved to a clinically meaningful degree according to ISI-a will be referred to their local child-and adolescent psychiatric clinic for further treatment
Statistical Analyses Outcomes will be described as significant changes in objective and subjective sleep and in clinician and self-rated measures of insomnia symptoms and comorbid symptoms within-group effect sizes Cohens d clinically significant improvement rates and remission rates Analyses will involve t-tests as well as linear mixed-effects modeling Randomness of missing data will be analyzed with logistic regression Depending on the amount of missing data multiple imputations will be employed to compensate for missing values
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None