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PsychotherapyNCT03806569

MAC-cbt Group Therapy for Adults With ADHD

A study testing MAC-cbt group treatment for adult ADHD and Jacobson in people with Psychotherapy, run by Peter Tonn at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psychotherapy
What is being tested?
MAC-cbt group treatment for adult ADHD and Jacobson
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteGermany
Study dates
1 Mar 2019to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Peter Tonn, Dr. med. contact

+494053307380

tonn@npz-hamburg.de

Steffen Moritz, Prof. contact

+49 (40) 7410-56565

moritz@uke.de

Germany1 site, 1 recruiting
  • Neuropsychiatric Center of Hamburg

    Hamburg, 22769

    Nina Schulze, MoS, +494053307380, schulze@npz-hamburg.de

    Isabelle Kuchler, M.Sc.

    Recruiting

Other trials in Germany

About this study

Official title: Mindfulness-Based Behavioural Group Therapy for Adult Attention Deficit Hyperactivity Disorder - Randomized Clinical Trial

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.

Read the 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.

Conditions
Psychotherapy
Being tested
MAC-cbt group treatment for adult ADHD, Jacobson
Keywords
cognitive behavioral therapy, mindfulness, acceptance, commitment, adult ADHD
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAC-cbt group treatment for adult ADHDBehavioural

    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.

  • JacobsonBehavioural

    Relaxation treatment in technique of Jacobson in 8 sessions

Study groups in NCT03806569
Study groupRoleWhat they receive
MAC-cbt group treatment for adult ADHDActive comparatorThe 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"
Receives: Behavioral: MAC-cbt group treatment for adult ADHD
Relaxation-group for adult ADHDSham comparatorThe patients will be treated with a relaxation-treatment, long-time established as "Jacobson muscle relaxing technique".
Receives: Behavioral: Jacobson

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Symptoms measured by the Connors ADHD Adult Rating Scale (CAARS)

    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.

    Measured: 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

Secondary outcomes (7)
  1. Measure of the quality of life of the participants measured by World Health Organization Quality of Life Questionnaire

    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).

    Measured: 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

  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)

    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.

    Measured: 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

  3. Changes of mindfulness measured by Mindful Attention Awareness Scale

    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.

    Measured: 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

  4. Changes of acceptance, measured by Acceptance and Action Questionnaire

    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.

    Measured: 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

  5. Affective state measured with the Patient Health Questionnaire PHQ-9

    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.

    Measured: 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

  6. Measuring of satisfaction and willingness to change with visual analogue scales

    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.

    Measured: 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

  7. Measuring of five individual parameters during every of the single treatment session

    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.

    Measured: Measurement before and after every treatment session, 2-6 weeks after inclusion date, every week for the 8 weeks treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2019
  2. Study start1 Mar 2019
  3. Primary completionApr 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
monocentric, parallel group randomized superiority study - one arm with new intervention, other arm with well established relaxation treatment
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03806569
Sponsor's protocol ID
KUCHLER_2018
Status last verified
Aug 2021
First submitted
14 Jan 2019
Last updated
20 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MAC-cbt group treatment for adult ADHD and Jacobson in people with Psychotherapy, run by Peter Tonn at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peter Tonn, Dr. med. (+494053307380, tonn@npz-hamburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.

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