<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015636</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1988-31</org_study_id>
    <nct_id>NCT03015636</nct_id>
  </id_info>
  <brief_title>Better Sleep in Psychiatric Care - ADHD.</brief_title>
  <acronym>BSIP-ADHD</acronym>
  <official_title>Better Sleep in Psychiatric Care - ADHD. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Attention Deficit Hyperactivity Disorder.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of ADHD, Northern Stockholm Psychiatry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). Many patients&#xD;
      in psychiatric care have sleep problems including insomnia, but are rarely given the choice&#xD;
      to participate in CBT to improve their sleep. Patients with ADHD is a patient group with high&#xD;
      levels of sleep difficulties. Sleep problems in this patient group can be both more general&#xD;
      such as insomnia, but can also be related to the ADHD itself and to the use of ADHD&#xD;
      medication. In a previous pilot study, the investigators developed a version of CBT-i that&#xD;
      would target sleep problems in this population. The basis was CBT-i, but with more emphasis&#xD;
      on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of ADHD-medication),&#xD;
      techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light&#xD;
      and darkness), and techniques to target more general sleep disturbing habits (e.g. not&#xD;
      winding down before bed time), that are also common in patients with ADHD. This treatment was&#xD;
      well tolerated and gave moderate effects on insomnia severity in the pilot study. In a&#xD;
      naturalistic randomized controlled trial, the investigators now evaluate the effects of this&#xD;
      psychological treatment on sleep and symptoms of ADHD in patients at the ADHD-clinics,&#xD;
      Northern Stockholm Psychiatry, Sweden.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">November 21, 2018</completion_date>
  <primary_completion_date type="Actual">November 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>Changes from base-line to 10 weeks and 3 months</time_frame>
    <description>7-item, self-rated questionnaire measuring change in insomnia severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Actigraphy</measure>
    <time_frame>Continuously from treatment start (week 1) to the last week of treatment (week 10)</time_frame>
    <description>An actigraph is placed on the participant's arm for one week. It measures participants' activity in the form of movements. It can be used for acquiring data on sleep and daytime activity, including calculated sleep latency, total sleep time, sleep efficiency, wake after sleep onset, variability in sleep timing and daytime activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep diary</measure>
    <time_frame>Changes from base-line to 10 weeks and 3 months</time_frame>
    <description>Daily self-ratings on a number of sleep parameters, resulting in several measures including sleep latency, wake after sleep onset, total sleep time, sleep efficiency, subjective sleep quality and variability in sleep timing</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Brunnsviken brief quality of life scale</measure>
    <time_frame>Changes from base-line to 10 weeks and 3 months</time_frame>
    <description>12-items self-rating questionnaire measuring quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adult ADHD Self-Report Scale</measure>
    <time_frame>Changes from base-line to 10 weeks and 3 months</time_frame>
    <description>18-items self-report questionnaire measuring ADHD-symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dysfunctional Beliefs and Attitudes about Sleep</measure>
    <time_frame>Changes from base-line to 10 weeks and 3 months</time_frame>
    <description>10-items self-rating questionnaire measuring sleep related cognitions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep Problems Acceptance Questionnaire</measure>
    <time_frame>Changes from base-line to 10 weeks and 3 months</time_frame>
    <description>8-items self-rating questionnaire measuring acceptance of sleep problems.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep habits and behaviors</measure>
    <time_frame>Changes from base-line to 10 weeks and 3 months</time_frame>
    <description>Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the current project and consists of two parts. The first part includes 16 statements such as &quot;Last week I got out of bed within 15 minutes of waking up&quot; to be answered by number of days the last week this was true (i.e. from 0 to 7). The other part is to be answered on a 6-point Likert scale from &quot;Not at all true&quot; to &quot;Entirely true&quot;, with 7 statements like &quot;I get out of bed the same time every morning&quot;.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Sleep Problem</condition>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>Behavioral: Adjusted CBT-i for ADHD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment as Usual. (After about ten weeks, participants in this condition are offered the experimental group treatment.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adjusted CBT-i for ADHD</intervention_name>
    <description>This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project. Traditional CBT-i is adjusted for use in the adult ADHD population. This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the ADHD-population. Treatment is given as 10 weekly group sessions with telephone calls from the therapist between sessions to increase adherence and adress individual patient needs.</description>
    <arm_group_label>Behavioral: Adjusted CBT-i for ADHD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Usual care at the ADHD-clinic. This mostly entails managing pharmacological treatment for ADHD, comorbid psychiatric problems and/or sleep problems. The clinic also provides different group treatments, for instance mindfulness groups and groups for developing behavioral strategies for managing ADHD symptoms, and individual therapy.</description>
    <arm_group_label>Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being a patient at the ADHD-clinics Northern Stockholm Psychiatry&#xD;
&#xD;
          -  Experiencing sleep problems (subjective report)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susanna Jernelöv, PhD, LP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of ADHD, Northern Stockholm Psychiatry</name>
      <address>
        <city>Stockholm</city>
        <zip>113 21</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.</citation>
    <PMID>11438246</PMID>
  </reference>
  <reference>
    <citation>Lindner P, Frykheden O, Forsstrom D, Andersson E, Ljotsson B, Hedman E, Andersson G, Carlbring P. The Brunnsviken Brief Quality of Life Scale (BBQ): Development and Psychometric Evaluation. Cogn Behav Ther. 2016 Apr;45(3):182-95. doi: 10.1080/16506073.2016.1143526. Epub 2016 Feb 17.</citation>
    <PMID>26886248</PMID>
  </reference>
  <reference>
    <citation>Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.</citation>
    <PMID>16923651</PMID>
  </reference>
  <reference>
    <citation>Espie CA, Inglis SJ, Harvey L, Tessier S. Insomniacs' attributions. psychometric properties of the Dysfunctional Beliefs and Attitudes about Sleep Scale and the Sleep Disturbance Questionnaire. J Psychosom Res. 2000 Feb;48(2):141-8. doi: 10.1016/s0022-3999(99)00090-2.</citation>
    <PMID>10719130</PMID>
  </reference>
  <reference>
    <citation>Bothelius K, Jernelov S, Fredrikson M, McCracken LM, Kaldo V. Measuring Acceptance of Sleep Difficulties: The Development of the Sleep Problem Acceptance Questionnaire. Sleep. 2015 Nov 1;38(11):1815-22. doi: 10.5665/sleep.5170.</citation>
    <PMID>26085302</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Susanna Jernelöv</investigator_full_name>
    <investigator_title>PhD, LP</investigator_title>
  </responsible_party>
  <keyword>Cognitive Behaviour Therapy</keyword>
  <keyword>Psychological Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015636
org study id: 2016/1988-31
nct id: NCT03015636
lead sponsor: 
collaborator: 
has dmc: No
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). Many patients
      in psychiatric care have sleep problems including insomnia, but are rarely given the choice
      to participate in CBT to improve their sleep. Patients with ADHD is a patient group with high
      levels of sleep difficulties. Sleep problems in this patient group can be both more general
      such as insomnia, but can also be related to the ADHD itself and to the use of ADHD
      medication. In a previous pilot study, the investigators developed a version of CBT-i that
      would target sleep problems in this population. The basis was CBT-i, but with more emphasis
      on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of ADHD-medication),
      techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light
      and darkness), and techniques to target more general sleep disturbing habits (e.g. not
      winding down before bed time), that are also common in patients with ADHD. This treatment was
      well tolerated and gave moderate effects on insomnia severity in the pilot study. In a
      naturalistic randomized controlled trial, the investigators now evaluate the effects of this
      psychological treatment on sleep and symptoms of ADHD in patients at the ADHD-clinics,
      Northern Stockholm Psychiatry, Sweden.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Insomnia Severity Index
time frame: Changes from base-line to 10 weeks and 3 months
description: 7-item, self-rated questionnaire measuring change in insomnia severity.
measure: Actigraphy
time frame: Continuously from treatment start (week 1) to the last week of treatment (week 10)
description: An actigraph is placed on the participant's arm for one week. It measures participants' activity in the form of movements. It can be used for acquiring data on sleep and daytime activity, including calculated sleep latency, total sleep time, sleep efficiency, wake after sleep onset, variability in sleep timing and daytime activity.
measure: Sleep diary
time frame: Changes from base-line to 10 weeks and 3 months
description: Daily self-ratings on a number of sleep parameters, resulting in several measures including sleep latency, wake after sleep onset, total sleep time, sleep efficiency, subjective sleep quality and variability in sleep timing
measure: Brunnsviken brief quality of life scale
time frame: Changes from base-line to 10 weeks and 3 months
description: 12-items self-rating questionnaire measuring quality of life.
measure: Adult ADHD Self-Report Scale
time frame: Changes from base-line to 10 weeks and 3 months
description: 18-items self-report questionnaire measuring ADHD-symptoms.
measure: Dysfunctional Beliefs and Attitudes about Sleep
time frame: Changes from base-line to 10 weeks and 3 months
description: 10-items self-rating questionnaire measuring sleep related cognitions.
measure: Sleep Problems Acceptance Questionnaire
time frame: Changes from base-line to 10 weeks and 3 months
description: 8-items self-rating questionnaire measuring acceptance of sleep problems.
measure: Sleep habits and behaviors
time frame: Changes from base-line to 10 weeks and 3 months
description: Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the current project and consists of two parts. The first part includes 16 statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7). The other part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning".
arm group label: Behavioral: Adjusted CBT-i for ADHD
arm group type: Experimental
description: Cognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders.
arm group label: Treatment as Usual
arm group type: Other
description: Treatment as Usual. (After about ten weeks, participants in this condition are offered the experimental group treatment.)
intervention type: Behavioral
intervention name: Adjusted CBT-i for ADHD
description: This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project. Traditional CBT-i is adjusted for use in the adult ADHD population. This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the ADHD-population. Treatment is given as 10 weekly group sessions with telephone calls from the therapist between sessions to increase adherence and adress individual patient needs.
arm group label: Behavioral: Adjusted CBT-i for ADHD
intervention type: Other
intervention name: Treatment as Usual
description: Usual care at the ADHD-clinic. This mostly entails managing pharmacological treatment for ADHD, comorbid psychiatric problems and/or sleep problems. The clinic also provides different group treatments, for instance mindfulness groups and groups for developing behavioral strategies for managing ADHD symptoms, and individual therapy.
arm group label: Treatment as Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susanna Jernelöv, PhD, LP
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
citation: Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PMID: 11438246
citation: Lindner P, Frykheden O, Forsstrom D, Andersson E, Ljotsson B, Hedman E, Andersson G, Carlbring P. The Brunnsviken Brief Quality of Life Scale (BBQ): Development and Psychometric Evaluation. Cogn Behav Ther. 2016 Apr;45(3):182-95. doi: 10.1080/16506073.2016.1143526. Epub 2016 Feb 17.
PMID: 26886248
citation: Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
PMID: 16923651
citation: Espie CA, Inglis SJ, Harvey L, Tessier S. Insomniacs' attributions. psychometric properties of the Dysfunctional Beliefs and Attitudes about Sleep Scale and the Sleep Disturbance Questionnaire. J Psychosom Res. 2000 Feb;48(2):141-8. doi: 10.1016/s0022-3999(99)00090-2.
PMID: 10719130
citation: Bothelius K, Jernelov S, Fredrikson M, McCracken LM, Kaldo V. Measuring Acceptance of Sleep Difficulties: The Development of the Sleep Problem Acceptance Questionnaire. Sleep. 2015 Nov 1;38(11):1815-22. doi: 10.5665/sleep.5170.
PMID: 26085302
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Susanna Jernelöv
investigator title: PhD, LP
mesh term: Dyssomnias
mesh term: Parasomnias
sharing ipd: Undecided