Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Stockholm、スウェーデン、11364
- BUP KFE
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:ICBT-I
The ICBT-I treatment program is a web-based intervention consisting of six chapters/sessions that adolescents go through during six consecutive weeks.The program starts with psychoeducation regarding sleep disorders and the rationale for a cognitive behavioral intervention.
The main focus for the treatment is behavioral interventions, mainly sleep restriction and stimulus control.
The intervention also addresses problem solving, maintenance of treatment gains, relapse prevention and relaxation techniques.
Caregivers will not actively participate in the treatment.
During the treatment phase participants will be in contact with a therapist through standardized forms in the program.
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Cognitive-behavioral therapy for insomnia
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in insomnia symptom severity
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in subjective total sleep time
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in subjective sleep onset latency
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in subjective wake after sleep onset
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in subjective sleep efficiency
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in objective sleep total sleep time
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in objective sleep onset latency
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in objective wake after sleep onset
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in objective sleep efficiency
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in symptoms of insomnia
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in symptoms of depression
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in symptoms of depression 2
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in symptoms of generalized anxiety
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in difficulties in emotion regulation
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in intensity of pain
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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
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Change in daytime functioning
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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).
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in daytime sleepiness 1
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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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.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Change in daytime sleepiness 2
時間枠:Change from before treatment to after (+6 weeks) and to 6 month after treatment
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Measured with the Karolinska Sleepiness Scale (KSS), a 9-point Likert scale, ranging from 1 to 9, with higher numbers denoting more sleepiness.
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Change from before treatment to after (+6 weeks) and to 6 month after treatment
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協力者と研究者
スポンサー
協力者
捜査官
- スタディチェア:Mats Lekander, PhD、Karolinska Institutet
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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うつ病性障害の臨床試験
ICBT-Iの臨床試験
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Helsinki University Central HospitalUniversity of Helsinki; Finnish Institute for Health and Welfare; Finnish Institute of Occupational...募集
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I.M. Sechenov First Moscow State Medical UniversityUniversity of Bern募集
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University of ReginaCanadian Institutes of Health Research (CIHR)完了
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Northwestern UniversityNational Institute of Mental Health (NIMH)完了
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Linkoeping UniversityStockholm University完了
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Foundation of Hope, North Carolina完了
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The University of Hong Kong募集