Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial
Condition: Insomnia Disorder; Depressive Disorder; Anxiety Disorders; Pain, Chronic; Inflammation
MeSH terms: Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders; Inflammation; Chronic Pain; Depressive Disorder; Anxiety Disorders
Study type: Interventional

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
      adolescent/parent in order to broadly assess inclusion and exclusion criteria.

      Face-to-face baseline diagnostic assessment: After the telephone screening, the adolescent
      along with his/her 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 days/nights.

      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 patient's well-being, e.g., 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 parents/adolescents 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 (Cohen's 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.
    

Intervention name(s): ICBT-I
Intervention type(s): Behavioral
Intervention description(s): Cognitive-behavioral therapy for insomnia
Intervention model: Single Group Assignment
Intervention model description: All participants will receive treatment
Masking: None (Open Label)
Primary purpose: Treatment