Development of an Insomnia Treatment for Depressed Adolescents
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|ClinicalTrials.gov Identifier: NCT02163564|
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : January 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Depression||Behavioral: Cognitive Behavioral Therapy for Insomnia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of an Insomnia Treatment for Depressed Adolescents|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||December 2015|
No Intervention: Focus groups
The first part of the study is to conduct focus groups of adolescents with insomnia and depression. The treatment arm is informed by responses provided by teens in the focus group portion.
Active Comparator: Treatment
A modified cognitive behavioral therapy for insomnia is the treatment intervention in this treatment arm.
Behavioral: Cognitive Behavioral Therapy for Insomnia
A non-pharmacological therapy for insomnia based on behavior and cognitive therapy approaches
Other Name: CBTI
- Insomnia Severity Index [ Time Frame: Change from baseline in insomnia at 5 weeks ]A 5-item insomnia severity questionnaire
- Multidimensional Fatigue Inventory [ Time Frame: Change from baseline in fatigue at 5 weeks ]A 14-item questionnaire on fatigue
- Quick Inventory of Depressive Symptomatology [ Time Frame: Change from baseline in depression at 5 weeks ]A 16-item questionnaire on depression
- Alcohol and drug use screening test (CRAFFT) [ Time Frame: Baseline ]A six item questionnaire that assesses risk and substance use. This questionaire is delivered once at baseline.
- Morningness Eveningness Questionnaire -modified [ Time Frame: Baseline ]A 10 item questionnaire assessing phase preference of evening, morning, or neither; This questionaire is delivered once at baseline.
- Sleep diaries [ Time Frame: Change from baseline in sleep at 5 weeks ]A subjective assessment of daily patterns of sleep
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163564
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|