<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/NCT03806569</url>
  </required_header>
  <id_info>
    <org_study_id>KUCHLER_2018</org_study_id>
    <nct_id>NCT03806569</nct_id>
  </id_info>
  <brief_title>MAC-cbt Group Therapy for Adults With ADHD</brief_title>
  <official_title>Mindfulness-Based Behavioural Group Therapy for Adult Attention Deficit Hyperactivity Disorder - Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peter Tonn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Neuropsychiatrischen Zentrums Hamburg-Altona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is developed to validate a new short psychotherapeutic group treatment for adults&#xD;
      with ADHD diagnosis. The participants will be treated in a monocentric, parallel group&#xD;
      randomized superiority study - one group with the new treatment and one group with well&#xD;
      established relaxing treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Attention deficit hyperactivity disorder (AD(H)D) symptoms are often assumed to&#xD;
      decease in adolescence, however in up to 60% of children, AD(H)D persists into adulthood.&#xD;
      Currently, pharmacological therapy is the number-one choice AD(H)D treatment. Despite its&#xD;
      evidenced effects of pharmacological interventions there are side effects, contraindications&#xD;
      and non-responders, which send some patients disliking the use of medication and asking for&#xD;
      alternative treatments. In previous studies mindfulness-based interventions already have&#xD;
      shown similar effects in neural regions as pharmacological treatment and positive changes in&#xD;
      AD(H)D symptoms, quality of life, awareness and concentration. The following study wants to&#xD;
      improve mindfulness-based treatment approaches in AD(H)D with a new therapy concept.&#xD;
&#xD;
      Methods: Mindfulness, acceptance, commitment and cognitive behavioral group therapy (MAC-CBT)&#xD;
      combines 3rd wave therapies with focus on mindfulness meditation, acceptance of&#xD;
      unchangeability, commitment to new goals with elements of cognitive behavioral therapy. The&#xD;
      design of this study is a single-center, parallel-group, randomized superiority trial. The&#xD;
      aim is to compare MAC-CBT group with progressive muscle relaxation training (PMR by&#xD;
      Jacobson). Both groups will be held over a period of eight weeks. Participants will be&#xD;
      assessed two times before treatment to determine natural course of adult AD(H)D and two times&#xD;
      after treatment to evaluate short and long term effects. A questionnaire battery and&#xD;
      neuropsychological tests are to be used to obtain results regarding a possible change in the&#xD;
      symptoms and attention, including selective attention.&#xD;
&#xD;
      Discussion: This trial will offer new knowledge about the effects of third wave therapies on&#xD;
      AD(H)D. Furthermore, the following study is one of few studies that will compare AD(H)D&#xD;
      treatment to relaxation training instead of comparison to waiting list. The aim of the&#xD;
      following study is to verify previous outcomes of mindfulness-based treatments on AD(H)D and&#xD;
      to evaluate superiority of mindfulness towards relaxation programs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</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>
    <intervention_model_description>monocentric, parallel group randomized superiority study - one arm with new intervention, other arm with well established relaxation treatment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>The participants will not know, in which of the arms they are; the outcomes assessor did not know the patients study-arm</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Symptoms measured by the Connors ADHD Adult Rating Scale (CAARS)</measure>
    <time_frame>Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention</time_frame>
    <description>The long version of the CAARS (Conner's Adult AD(H)D Rating Scales (Christiansen et al., 2012)) combines self-report and observer rating questionnaires to assess current AD(H)D symptoms in adulthood. This instrument consists of 66 items based on a 4-point Likert scale and four subscales: Inattention/ Memory Problems, Hyperactivity/ Restlessness, Impulsivity/ Emotional Lability and Problems with Self-Concept. With regard to the scientific quality criteria, Christiansen (2012) reports internal consistencies with a Cronbach's α of .74 to .95 and a test-retest reliability from .71 to .93, range min. 66 to max. 264 points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of the quality of life of the participants measured by World Health Organization Quality of Life Questionnaire</measure>
    <time_frame>Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention</time_frame>
    <description>Quality of life will be assessed by the short version of WHOQOL-BREF (World Health Organization Quality of Life Questionnaire (Group, 1998)). The questionnaire consists of 26 items that were extracted from the complete version consists of 100 items (WHOQOL-100) based on a 5-point Likert scale. For the German short version, Cronbach's alpha scores between .76 and .88 (Skevington, Lotfy, O'Connell, &amp; Group, 2004). Range from 26 to 105 (min.-max).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of attention functioning measured by change detection task and trail making test A and B of the computer based test setting Psychology Experiment Building Language (PEBL)</measure>
    <time_frame>Measurement 1 at inclusion , Measurement 2 is 2 months after inclusion, measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention</time_frame>
    <description>The change detection task, modeled paradigm by Luck and Vogel, examines the visual working memory and covers sustained and selective attention. Patients will see a first pattern of differently colored squares for 300ms followed by a 1000ms pause and then a second pattern of squares. The task is then to determine whether the colors of every square are identical, will be repeated 120 times and takes approximately 12 minutes in total. Reaction times and the amount of mistakes made will then give information on the level of functioning. In addition, a TMT-A and B (Reitan, 1992) will be conducted. Patients will be asked to first connect numbers ranging from 1 to 30 in increasing order and then numbers from one to 15 and letters from A through O alphabetically alternating. Reaction times, times between clicks and the amount of correct and incorrect clicks will provide insight to the level of attentional functioning. Measurement of single individual scores, no qualified range described.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of mindfulness measured by Mindful Attention Awareness Scale</measure>
    <time_frame>Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention</time_frame>
    <description>In order to assess mindfulness as well as the perception of the &quot;here and now&quot;, the German version of the MAAS (Mindful Attention Awareness Scale (Brown &amp; Ryan, 2003)) is used. In total, it consists of 15 items on a 6-point Likert scale. Since non-mindful behaviors are described, high scores mean a higher level of mindfulness. The internal consistency, represented by Cronbach's alpha, amounts α = .83 for the German version (Michalak, Heidenreich, Ströhle, &amp; Nachtigall, 2008).Range form 15 to 90 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of acceptance, measured by Acceptance and Action Questionnaire</measure>
    <time_frame>Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention</time_frame>
    <description>The FAH II Questionnaire (Acceptance and Action Questionnaire), the German version of AAQ (Acceptance and Action Questionnaire (Bond et al., 2011; Hoyer &amp; Gloster, 2013)), aims to measure acceptance and psychological flexibility. The questionnaire consists of seven items, based on a 7-point Likert scale. Hoyer and Gloster found Cronbach's alpha between.84 and .97 and a test-retest reliability of rtt = .74 - .85 for the German version (2011). Range from 7 to 49 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affective state measured with the Patient Health Questionnaire PHQ-9</measure>
    <time_frame>Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention</time_frame>
    <description>The PHQ (Patient Health Questionnaire, (Gräfe, Zipfel, Herzog, &amp; Löwe, 2004)) is used for psychodiagnostic screening and a possible change in patient depression. It is a self-assessment tool based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV (Saß &amp; Association, 1998)) and includes modules on somatoform disorders, depressive disorders, anxiety disorders, and eating disorders, alcohol abuse, psychosocial functioning, stressors, critical life events and for participants to menstruation, pregnancy and childbirth. In total, it contains 78 items, which are based on a 2- to 5-point Likert scale depending on the module. For the depression scale of PHQ-D the internal consistency according to Cronbach's alpha is α = .88, for the somatization scale α = .79. Different subscales, no combined score, individual ranges and scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring of satisfaction and willingness to change with visual analogue scales</measure>
    <time_frame>Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention</time_frame>
    <description>Visual analogue scales (VAS) with regard to satisfaction with mental health and the willingness to change are going to be evaluated.Range from 0 to 10 per scale, no combined scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring of five individual parameters during every of the single treatment session</measure>
    <time_frame>Measurement before and after every treatment session, 2-6 weeks after inclusion date, every week for the 8 weeks treatment period</time_frame>
    <description>Each time before and after the therapy sessions, five visual analogue scales are to be filled in, on which patients evaluate their current mood, stress, restlessness, trust in effectiveness of psychotherapy and their energy level. Range from 0 to 10 per scale, no combined scores.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Psychotherapy</condition>
  <arm_group>
    <arm_group_label>MAC-cbt group treatment for adult ADHD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will be treated with psychological group treatment for 8 sessions with focus on mindfulness, acceptance and commitment in a special adapted treatment process. This will be called &quot;Mindfulness, Acceptance and Commitment-Therapy for adult Patients with ADHD&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation-group for adult ADHD</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The patients will be treated with a relaxation-treatment, long-time established as &quot;Jacobson muscle relaxing technique&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MAC-cbt group treatment for adult ADHD</intervention_name>
    <description>Psychotherapeutic intervention to treat adult patients with ADHD to be mindful, accept the symptoms and disturbances and commit with the situation or the possibility to change.</description>
    <arm_group_label>MAC-cbt group treatment for adult ADHD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Jacobson</intervention_name>
    <description>Relaxation treatment in technique of Jacobson in 8 sessions</description>
    <arm_group_label>Relaxation-group for adult ADHD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult ADHD&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  stable medication for at least two weeks&#xD;
&#xD;
          -  sufficient knowledge of the German language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  personality disorder&#xD;
&#xD;
          -  schizophrenia / psychotic disorders&#xD;
&#xD;
          -  bipolar disorder&#xD;
&#xD;
          -  acute suicidality&#xD;
&#xD;
          -  disease of the central nervous system&#xD;
&#xD;
          -  no other psychotherapeutic treatment at the time of the study&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  IQ below 70 Points&#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_official>
    <last_name>Steffen Moritz, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UKE Hamburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Tonn, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NPZ Hamburg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Tonn, Dr. med.</last_name>
    <phone>+494053307380</phone>
    <email>tonn@npz-hamburg.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Steffen Moritz, Prof.</last_name>
    <phone>+49 (40) 7410-56565</phone>
    <email>moritz@uke.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Neuropsychiatric Center of Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>22769</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nina Schulze, MoS</last_name>
      <phone>+494053307380</phone>
      <email>schulze@npz-hamburg.de</email>
    </contact>
    <investigator>
      <last_name>Isabelle Kuchler, M.Sc.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hanna Siemoneit, M.Sc.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>August 19, 2021</last_update_submitted>
  <last_update_submitted_qc>August 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Neuropsychiatrischen Zentrums Hamburg-Altona</investigator_affiliation>
    <investigator_full_name>Peter Tonn</investigator_full_name>
    <investigator_title>Director of the Center</investigator_title>
  </responsible_party>
  <keyword>cognitive behavioral therapy</keyword>
  <keyword>mindfulness</keyword>
  <keyword>acceptance</keyword>
  <keyword>commitment</keyword>
  <keyword>adult ADHD</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03806569
org study id: KUCHLER_2018
nct id: NCT03806569
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is developed to validate a new short psychotherapeutic group treatment for adults
      with ADHD diagnosis. The participants will be treated in a monocentric, parallel group
      randomized superiority study - one group with the new treatment and one group with well
      established relaxing treatment.
Background: Attention deficit hyperactivity disorder (AD(H)D) symptoms are often assumed to
      decease in adolescence, however in up to 60% of children, AD(H)D persists into adulthood.
      Currently, pharmacological therapy is the number-one choice AD(H)D treatment. Despite its
      evidenced effects of pharmacological interventions there are side effects, contraindications
      and non-responders, which send some patients disliking the use of medication and asking for
      alternative treatments. In previous studies mindfulness-based interventions already have
      shown similar effects in neural regions as pharmacological treatment and positive changes in
      AD(H)D symptoms, quality of life, awareness and concentration. The following study wants to
      improve mindfulness-based treatment approaches in AD(H)D with a new therapy concept.

      Methods: Mindfulness, acceptance, commitment and cognitive behavioral group therapy (MAC-CBT)
      combines 3rd wave therapies with focus on mindfulness meditation, acceptance of
      unchangeability, commitment to new goals with elements of cognitive behavioral therapy. The
      design of this study is a single-center, parallel-group, randomized superiority trial. The
      aim is to compare MAC-CBT group with progressive muscle relaxation training (PMR by
      Jacobson). Both groups will be held over a period of eight weeks. Participants will be
      assessed two times before treatment to determine natural course of adult AD(H)D and two times
      after treatment to evaluate short and long term effects. A questionnaire battery and
      neuropsychological tests are to be used to obtain results regarding a possible change in the
      symptoms and attention, including selective attention.

      Discussion: This trial will offer new knowledge about the effects of third wave therapies on
      AD(H)D. Furthermore, the following study is one of few studies that will compare AD(H)D
      treatment to relaxation training instead of comparison to waiting list. The aim of the
      following study is to verify previous outcomes of mindfulness-based treatments on AD(H)D and
      to evaluate superiority of mindfulness towards relaxation programs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: monocentric, parallel group randomized superiority study - one arm with new intervention, other arm with well established relaxation treatment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: The participants will not know, in which of the arms they are; the outcomes assessor did not know the patients study-arm
measure: Change of Symptoms measured by the Connors ADHD Adult Rating Scale (CAARS)
time frame: Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention
description: The long version of the CAARS (Conner's Adult AD(H)D Rating Scales (Christiansen et al., 2012)) combines self-report and observer rating questionnaires to assess current AD(H)D symptoms in adulthood. This instrument consists of 66 items based on a 4-point Likert scale and four subscales: Inattention/ Memory Problems, Hyperactivity/ Restlessness, Impulsivity/ Emotional Lability and Problems with Self-Concept. With regard to the scientific quality criteria, Christiansen (2012) reports internal consistencies with a Cronbach's α of .74 to .95 and a test-retest reliability from .71 to .93, range min. 66 to max. 264 points.
measure: Measure of the quality of life of the participants measured by World Health Organization Quality of Life Questionnaire
time frame: Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention
description: Quality of life will be assessed by the short version of WHOQOL-BREF (World Health Organization Quality of Life Questionnaire (Group, 1998)). The questionnaire consists of 26 items that were extracted from the complete version consists of 100 items (WHOQOL-100) based on a 5-point Likert scale. For the German short version, Cronbach's alpha scores between .76 and .88 (Skevington, Lotfy, O'Connell, & Group, 2004). Range from 26 to 105 (min.-max).
measure: Changes of attention functioning measured by change detection task and trail making test A and B of the computer based test setting Psychology Experiment Building Language (PEBL)
time frame: Measurement 1 at inclusion , Measurement 2 is 2 months after inclusion, measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention
description: The change detection task, modeled paradigm by Luck and Vogel, examines the visual working memory and covers sustained and selective attention. Patients will see a first pattern of differently colored squares for 300ms followed by a 1000ms pause and then a second pattern of squares. The task is then to determine whether the colors of every square are identical, will be repeated 120 times and takes approximately 12 minutes in total. Reaction times and the amount of mistakes made will then give information on the level of functioning. In addition, a TMT-A and B (Reitan, 1992) will be conducted. Patients will be asked to first connect numbers ranging from 1 to 30 in increasing order and then numbers from one to 15 and letters from A through O alphabetically alternating. Reaction times, times between clicks and the amount of correct and incorrect clicks will provide insight to the level of attentional functioning. Measurement of single individual scores, no qualified range described.
measure: Changes of mindfulness measured by Mindful Attention Awareness Scale
time frame: Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention
description: In order to assess mindfulness as well as the perception of the "here and now", the German version of the MAAS (Mindful Attention Awareness Scale (Brown & Ryan, 2003)) is used. In total, it consists of 15 items on a 6-point Likert scale. Since non-mindful behaviors are described, high scores mean a higher level of mindfulness. The internal consistency, represented by Cronbach's alpha, amounts α = .83 for the German version (Michalak, Heidenreich, Ströhle, & Nachtigall, 2008).Range form 15 to 90 points.
measure: Changes of acceptance, measured by Acceptance and Action Questionnaire
time frame: Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention
description: The FAH II Questionnaire (Acceptance and Action Questionnaire), the German version of AAQ (Acceptance and Action Questionnaire (Bond et al., 2011; Hoyer & Gloster, 2013)), aims to measure acceptance and psychological flexibility. The questionnaire consists of seven items, based on a 7-point Likert scale. Hoyer and Gloster found Cronbach's alpha between.84 and .97 and a test-retest reliability of rtt = .74 - .85 for the German version (2011). Range from 7 to 49 points.
measure: Affective state measured with the Patient Health Questionnaire PHQ-9
time frame: Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention
description: The PHQ (Patient Health Questionnaire, (Gräfe, Zipfel, Herzog, & Löwe, 2004)) is used for psychodiagnostic screening and a possible change in patient depression. It is a self-assessment tool based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV (Saß & Association, 1998)) and includes modules on somatoform disorders, depressive disorders, anxiety disorders, and eating disorders, alcohol abuse, psychosocial functioning, stressors, critical life events and for participants to menstruation, pregnancy and childbirth. In total, it contains 78 items, which are based on a 2- to 5-point Likert scale depending on the module. For the depression scale of PHQ-D the internal consistency according to Cronbach's alpha is α = .88, for the somatization scale α = .79. Different subscales, no combined score, individual ranges and scores.
measure: Measuring of satisfaction and willingness to change with visual analogue scales
time frame: Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention
description: Visual analogue scales (VAS) with regard to satisfaction with mental health and the willingness to change are going to be evaluated.Range from 0 to 10 per scale, no combined scores.
measure: Measuring of five individual parameters during every of the single treatment session
time frame: Measurement before and after every treatment session, 2-6 weeks after inclusion date, every week for the 8 weeks treatment period
description: Each time before and after the therapy sessions, five visual analogue scales are to be filled in, on which patients evaluate their current mood, stress, restlessness, trust in effectiveness of psychotherapy and their energy level. Range from 0 to 10 per scale, no combined scores.
arm group label: MAC-cbt group treatment for adult ADHD
arm group type: Active Comparator
description: The patients will be treated with psychological group treatment for 8 sessions with focus on mindfulness, acceptance and commitment in a special adapted treatment process. This will be called "Mindfulness, Acceptance and Commitment-Therapy for adult Patients with ADHD"
arm group label: Relaxation-group for adult ADHD
arm group type: Sham Comparator
description: The patients will be treated with a relaxation-treatment, long-time established as "Jacobson muscle relaxing technique".
intervention type: Behavioral
intervention name: MAC-cbt group treatment for adult ADHD
description: Psychotherapeutic intervention to treat adult patients with ADHD to be mindful, accept the symptoms and disturbances and commit with the situation or the possibility to change.
arm group label: MAC-cbt group treatment for adult ADHD
intervention type: Behavioral
intervention name: Jacobson
description: Relaxation treatment in technique of Jacobson in 8 sessions
arm group label: Relaxation-group for adult ADHD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Steffen Moritz, Prof.
role: Principal Investigator
affiliation: UKE Hamburg
last name: Peter Tonn, Dr. med.
role: Principal Investigator
affiliation: NPZ Hamburg
last name: Peter Tonn, Dr. med.
phone: +494053307380
email: tonn@npz-hamburg.de
last name: Steffen Moritz, Prof.
phone: +49 (40) 7410-56565
email: moritz@uke.de
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Neuropsychiatrischen Zentrums Hamburg-Altona
investigator full name: Peter Tonn
investigator title: Director of the Center
sharing ipd: No