<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/NCT04439422</url>
  </required_header>
  <id_info>
    <org_study_id>SAINT</org_study_id>
    <nct_id>NCT04439422</nct_id>
  </id_info>
  <brief_title>Short Structured Psychological Intervention for Adults With ADHD - a Randomized Controlled Trial</brief_title>
  <official_title>Short Structured Psychological Intervention for Adults With ADHD - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cereb AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cereb AB</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of a novel psychological intervention&#xD;
      for adult ADHD through a randomized controlled trial. Participants will be randomized to&#xD;
      receive either a face-to-face manualized short psychological intervention, SAINT, or&#xD;
      corresponding self-help material with limited access to therapist support. The main objective&#xD;
      is to evaluate whether SAINT will show better outcomes on measures of ADHD-related symptoms,&#xD;
      everyday function, and quality-of-life measures, when compared to the self-help material, and&#xD;
      if any possible differences in outcomes are related to better treatment adherence in SAINT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ADHD is associated with deficiencies in short-term memory and executive function, negatively&#xD;
      affecting patients' abilities to organize, schedule, multitask, follow through on&#xD;
      instructions and finish jobs. This leads to uneven performance and possibly chronic&#xD;
      underperformance in relation to actual intellectual resources. Psychiatric comorbidity is&#xD;
      common for patients with ADHD, with 70-80% of adult patients meeting the criteria for at&#xD;
      least one more clinical diagnosis. ADHD is also associated with sensation seeking and&#xD;
      reckless behavior, including substance use and criminal activity.&#xD;
&#xD;
      Despite an increase in demand for assessment and treatment of ADHD among adults, access to&#xD;
      evidence-based treatment is limited. In Sweden, most adult patients with ADHD are only&#xD;
      offered pharmacological treatment. Pharmacological treatment, while in many cases effective,&#xD;
      does not meet the demands of all patients, with 20-50% of patients not experiencing enough&#xD;
      initial effect and/or excessive side-effects. Pharmacological treatment of ADHD also shows&#xD;
      problems with long-term adherence, with approximately half of patients terminating treatment&#xD;
      within the first two years, regardless of initial effect. Research on psychological treatment&#xD;
      for adult ADHD is limited, though studies on behavioral treatment, including short-term&#xD;
      therapies based on cognitive behavior therapy (CBT) and dialectic behavior therapy (DBT),&#xD;
      have shown promising results.&#xD;
&#xD;
      This project, dubbed Short ADHD Intervention (SAINT), is based on previous research and&#xD;
      pilot-studies of psychological treatments for adult ADHD. An existing treatment manual, based&#xD;
      on CBT and DBT practices, will be fitted into a five-session, intensive face-to-face&#xD;
      behavioral intervention, with a booster session at a one-month follow-up. The intervention&#xD;
      will be compared to an equally long, active comparative control, consisting of self-help&#xD;
      material and limited therapist support via Internet. Approximately 80 participants will be&#xD;
      recruited at outpatient clinics in Stockholm. The participants will be randomized to receive&#xD;
      either SAINT or the self-help material and limited therapist support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2021</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change (from baseline) on The Adult ADHD Quality of Life Questionnaire (AAQoL)</measure>
    <time_frame>Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) on ADHD Self-Report Scale (ASRS; Self-report)</measure>
    <time_frame>Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) on the ADHD Rating Scale (ADHD RS; Assessed by an expert rater)</measure>
    <time_frame>Baseline, 5 weeks (post treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) on Montgomery Åsberg Depression Rating Scale (MADRS-S; Self-report)</measure>
    <time_frame>Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) on Sheehan Disability Scale (SDS; Self-report)</measure>
    <time_frame>Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) on Difficulties in Emotion Regulation Scale (Brief Version; DERS-16; Self-report)</measure>
    <time_frame>Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) on Satisfaction With Life Scale (SWLS; Self-report)</measure>
    <time_frame>Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) on Perceived Stress Scale (PSS; Self-report)</measure>
    <time_frame>Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) on Clinical Global Impression - Severity Scale (CGI-S; Assessed by an expert rater)</measure>
    <time_frame>Baseline, 5 weeks (post treatment)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Global Impression - Improvement Scale (CGI-I; Assessed by an expert rater)</measure>
    <time_frame>5 weeks (post treatment)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-8; Self-report)</measure>
    <time_frame>5 weeks (post treatment)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Credibility Scale (TCS; Self-report)</measure>
    <time_frame>1 week, 3 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Evaluation (Self-report)</measure>
    <time_frame>5 weeks (post treatment)</time_frame>
    <description>A tailor-made formulary to evaluate the participants' experience of the interventions, including any possible difficulties.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence to Treatment (Self-report)</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)</time_frame>
    <description>Using a tailor-made formulary.</description>
  </other_outcome>
  <other_outcome>
    <measure>Session Attendance (Assessed by an expert rater)</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment), 9 weeks (FU1)</time_frame>
    <description>SAINT arm only.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events During Treatment (Self-report)</measure>
    <time_frame>5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)</time_frame>
    <description>Using a tailor-made formulary.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Other Treatment(s) During the Study Period (Self-report)</measure>
    <time_frame>5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)</time_frame>
    <description>Using a tailor-made formulary.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Attention Deficit Disorder With Hyperactivity</condition>
  <arm_group>
    <arm_group_label>SAINT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-help material</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Short ADHD Intervention</intervention_name>
    <description>Short, intensive psychological intervention based on CBT and DBT practices</description>
    <arm_group_label>SAINT</arm_group_label>
    <other_name>SAINT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-help material with limited therapist support</intervention_name>
    <description>Self-help material from an evidence-based treatment manual for adult ADHD with access to limited therapist support via Internet (control group)</description>
    <arm_group_label>Self-help material</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Swedish citizen&#xD;
&#xD;
          -  Clinical Diagnosis of ADHD according to DSM-IV or DSM-5.&#xD;
&#xD;
          -  Score of 17 or higher on the Adult ADHD Self Report Scale (ASRS v1.1), on any one of&#xD;
             the two subscales.&#xD;
&#xD;
          -  Not medically treated for ADHD symptoms throughout the study period, or medically&#xD;
             treated with central stimulants or comparable substances since at least one month,&#xD;
             with no significant changes in dosage and no anticipated significant changes in&#xD;
             dosage.&#xD;
&#xD;
          -  No change in any other medical treatment for psychiatric symptoms.&#xD;
&#xD;
          -  Ability to participate in treatment during the study period.&#xD;
&#xD;
          -  Abstinence from illegal substance use for at least three months.&#xD;
&#xD;
          -  Access to and ability to use Internet and mobile phone during the study period.&#xD;
&#xD;
          -  Ability to understand Swedish in speech and writing, and ability to fill-out forms&#xD;
             online.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of substance use disorder within three months prior to screening.&#xD;
             Earlier episodic use of illegal substances is not excluding.&#xD;
&#xD;
          -  Co-existing psychiatric condition or disorder expected to render the participant&#xD;
             unable to follow-through the study processes.&#xD;
&#xD;
          -  IQ ≤85 according to a prior neuropsychological assessment.&#xD;
&#xD;
          -  Suicidality assessed at the first assessment interview.&#xD;
&#xD;
          -  Organic brain syndrome.&#xD;
&#xD;
          -  Autism spectrum disorder (ASD) where function is deemed too low for the treatment to&#xD;
             be carried out, defined as ASD level 2 and level 3 according to DSM-5 and/or ASD with&#xD;
             accompanying intellectual impairment and/or accompanying language impairment.&#xD;
&#xD;
          -  Severe depression, defined as &gt;34 on the MADRS-S or at a clinical assessment.&#xD;
&#xD;
          -  Other current psychological treatment for ADHD or prior participation in treatment&#xD;
             deemed to interfere with the study design.&#xD;
&#xD;
          -  Limited or very limited self-rated recognition of problems regarding impulse control&#xD;
             and/or emotional instability, in combination with low self-rated impairment, on a&#xD;
             tailor-made measure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Berkeh Nasri, PhD</last_name>
    <phone>+46739328138</phone>
    <email>berkeh.nasri@cereb.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cereb AB</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Berkeh Nasri, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>October 11, 2020</last_update_submitted>
  <last_update_submitted_qc>October 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cereb AB</investigator_affiliation>
    <investigator_full_name>Berkeh Nasri</investigator_full_name>
    <investigator_title>PhD, Head of Research and Development</investigator_title>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>Attention Deficit</keyword>
  <keyword>Psychological Intervention</keyword>
  <keyword>CBT</keyword>
  <keyword>DBT</keyword>
  <keyword>Self-Help</keyword>
  <keyword>Adherence</keyword>
  <keyword>Short Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT04439422
org study id: SAINT
nct id: NCT04439422
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effects of a novel psychological intervention
      for adult ADHD through a randomized controlled trial. Participants will be randomized to
      receive either a face-to-face manualized short psychological intervention, SAINT, or
      corresponding self-help material with limited access to therapist support. The main objective
      is to evaluate whether SAINT will show better outcomes on measures of ADHD-related symptoms,
      everyday function, and quality-of-life measures, when compared to the self-help material, and
      if any possible differences in outcomes are related to better treatment adherence in SAINT.
ADHD is associated with deficiencies in short-term memory and executive function, negatively
      affecting patients' abilities to organize, schedule, multitask, follow through on
      instructions and finish jobs. This leads to uneven performance and possibly chronic
      underperformance in relation to actual intellectual resources. Psychiatric comorbidity is
      common for patients with ADHD, with 70-80% of adult patients meeting the criteria for at
      least one more clinical diagnosis. ADHD is also associated with sensation seeking and
      reckless behavior, including substance use and criminal activity.

      Despite an increase in demand for assessment and treatment of ADHD among adults, access to
      evidence-based treatment is limited. In Sweden, most adult patients with ADHD are only
      offered pharmacological treatment. Pharmacological treatment, while in many cases effective,
      does not meet the demands of all patients, with 20-50% of patients not experiencing enough
      initial effect and/or excessive side-effects. Pharmacological treatment of ADHD also shows
      problems with long-term adherence, with approximately half of patients terminating treatment
      within the first two years, regardless of initial effect. Research on psychological treatment
      for adult ADHD is limited, though studies on behavioral treatment, including short-term
      therapies based on cognitive behavior therapy (CBT) and dialectic behavior therapy (DBT),
      have shown promising results.

      This project, dubbed Short ADHD Intervention (SAINT), is based on previous research and
      pilot-studies of psychological treatments for adult ADHD. An existing treatment manual, based
      on CBT and DBT practices, will be fitted into a five-session, intensive face-to-face
      behavioral intervention, with a booster session at a one-month follow-up. The intervention
      will be compared to an equally long, active comparative control, consisting of self-help
      material and limited therapist support via Internet. Approximately 80 participants will be
      recruited at outpatient clinics in Stockholm. The participants will be randomized to receive
      either SAINT or the self-help material and limited therapist support.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change (from baseline) on The Adult ADHD Quality of Life Questionnaire (AAQoL)
time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
measure: Change (from baseline) on ADHD Self-Report Scale (ASRS; Self-report)
time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
measure: Change (from baseline) on the ADHD Rating Scale (ADHD RS; Assessed by an expert rater)
time frame: Baseline, 5 weeks (post treatment)
measure: Change (from baseline) on Montgomery Åsberg Depression Rating Scale (MADRS-S; Self-report)
time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
measure: Change (from baseline) on Sheehan Disability Scale (SDS; Self-report)
time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
measure: Change (from baseline) on Difficulties in Emotion Regulation Scale (Brief Version; DERS-16; Self-report)
time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
measure: Change (from baseline) on Satisfaction With Life Scale (SWLS; Self-report)
time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
measure: Change (from baseline) on Perceived Stress Scale (PSS; Self-report)
time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
measure: Change (from baseline) on Clinical Global Impression - Severity Scale (CGI-S; Assessed by an expert rater)
time frame: Baseline, 5 weeks (post treatment)
measure: Clinical Global Impression - Improvement Scale (CGI-I; Assessed by an expert rater)
time frame: 5 weeks (post treatment)
measure: Client Satisfaction Questionnaire (CSQ-8; Self-report)
time frame: 5 weeks (post treatment)
measure: Treatment Credibility Scale (TCS; Self-report)
time frame: 1 week, 3 weeks
measure: Treatment Evaluation (Self-report)
time frame: 5 weeks (post treatment)
description: A tailor-made formulary to evaluate the participants' experience of the interventions, including any possible difficulties.
measure: Adherence to Treatment (Self-report)
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)
description: Using a tailor-made formulary.
measure: Session Attendance (Assessed by an expert rater)
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment), 9 weeks (FU1)
description: SAINT arm only.
measure: Adverse Events During Treatment (Self-report)
time frame: 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
description: Using a tailor-made formulary.
measure: Changes in Other Treatment(s) During the Study Period (Self-report)
time frame: 5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)
description: Using a tailor-made formulary.
arm group label: SAINT
arm group type: Experimental
arm group label: Self-help material
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Short ADHD Intervention
description: Short, intensive psychological intervention based on CBT and DBT practices
arm group label: SAINT
other name: SAINT
intervention type: Other
intervention name: Self-help material with limited therapist support
description: Self-help material from an evidence-based treatment manual for adult ADHD with access to limited therapist support via Internet (control group)
arm group label: Self-help material
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Berkeh Nasri, PhD
phone: +46739328138
email: berkeh.nasri@cereb.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Cereb AB
investigator full name: Berkeh Nasri
investigator title: PhD, Head of Research and Development
mesh term: Attention Deficit Disorder with Hyperactivity