Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MAC-cbt Group Therapy for Adults With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03806569
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Peter Tonn, Neuropsychiatrischen Zentrums Hamburg-Altona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psychotherapy Behavioral: MAC-cbt group treatment for adult ADHD Behavioral: Jacobson Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
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
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
Primary Purpose: Treatment
Official Title: Mindfulness-Based Behavioural Group Therapy for Adult Attention Deficit Hyperactivity Disorder - Randomized Clinical Trial
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MAC-cbt group treatment for adult ADHD
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"
Behavioral: MAC-cbt group treatment for adult ADHD
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.

Sham Comparator: Relaxation-group for adult ADHD
The patients will be treated with a relaxation-treatment, long-time established as "Jacobson muscle relaxing technique".
Behavioral: Jacobson
Relaxation treatment in technique of Jacobson in 8 sessions




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. 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 ]
    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.

  6. 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 ]
    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.

  7. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult ADHD
  • written informed consent
  • stable medication for at least two weeks
  • sufficient knowledge of the German language

Exclusion Criteria:

  • personality disorder
  • schizophrenia / psychotic disorders
  • bipolar disorder
  • acute suicidality
  • disease of the central nervous system
  • no other psychotherapeutic treatment at the time of the study
  • pregnancy
  • IQ below 70 Points

Information from the National Library of Medicine

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): NCT03806569


Contacts
Layout table for location contacts
Contact: Peter Tonn, Dr. med. +494053307380 tonn@npz-hamburg.de
Contact: Steffen Moritz, Prof. +49 (40) 7410-56565 moritz@uke.de

Locations
Layout table for location information
Germany
Neuropsychiatric Center of Hamburg Recruiting
Hamburg, Germany, 22769
Contact: Nina Schulze, MoS    +494053307380    schulze@npz-hamburg.de   
Sub-Investigator: Isabelle Kuchler, M.Sc.         
Sub-Investigator: Hanna Siemoneit, M.Sc.         
Sponsors and Collaborators
Peter Tonn
Universitätsklinikum Hamburg-Eppendorf
Investigators
Layout table for investigator information
Principal Investigator: Steffen Moritz, Prof. UKE Hamburg
Principal Investigator: Peter Tonn, Dr. med. NPZ Hamburg

Layout table for additonal information
Responsible Party: Peter Tonn, Director of the Center, Neuropsychiatrischen Zentrums Hamburg-Altona
ClinicalTrials.gov Identifier: NCT03806569     History of Changes
Other Study ID Numbers: KUCHLER_2018
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Tonn, Neuropsychiatrischen Zentrums Hamburg-Altona:
cognitive behavioral therapy
mindfulness
acceptance
commitment
adult ADHD