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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Germany1 site, 1 recruiting
- Recruiting
Neuropsychiatric Center of Hamburg
Hamburg, 22769
Nina Schulze, MoS, +494053307380, schulze@npz-hamburg.de
Isabelle Kuchler, M.Sc.
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 group | Role | What they receive |
|---|---|---|
| MAC-cbt group treatment for adult ADHD | Active comparator | 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" Receives: Behavioral: MAC-cbt group treatment for adult ADHD |
| Relaxation-group for adult ADHD | Sham comparator | The 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.
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)
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
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
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
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
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
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
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.
- First posted16 Jan 2019
- Study start1 Mar 2019
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Peter Tonn
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor-investigator, Peter Tonn, Neuropsychiatrischen Zentrums Hamburg-Altona
- Investigators
- Steffen Moritz, Prof., Principal investigator, UKE HamburgPeter Tonn, Dr. med., Principal investigator, NPZ Hamburg
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Behavioural Group Therapy for Adult Attention Deficit Hyperactivity Disorder - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03806569
- Acronym / sponsor ID
- KUCHLER_2018
- Conditions
- Psychotherapy
- Keywords
- cognitive behavioral therapy, mindfulness, acceptance, commitment, adult ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peter TonnUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- monocentric, parallel group randomized superiority study - one arm with new intervention, other arm with well established relaxation treatment
| Arm | Type | Receives |
|---|---|---|
| MAC-cbt group treatment for adult ADHD | Active comparator | Behavioral: MAC-cbt group treatment for adult ADHDThe 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" |
| Relaxation-group for adult ADHD | Sham comparator | Behavioral: JacobsonThe patients will be treated with a relaxation-treatment, long-time established as "Jacobson muscle relaxing technique". |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult ADHD
- written informed consent
- stable medication for at least two weeks
- sufficient knowledge of the German language
Key exclusion criteria (8 listed)
- personality disorder
- schizophrenia / psychotic disorders
- bipolar disorder
- acute suicidality
- disease of the central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAC-cbt group treatment for adult ADHDPsychotherapeutic 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. | Behavioural | MAC-cbt group treatment for adult ADHD |
| JacobsonRelaxation treatment in technique of Jacobson in 8 sessions | Behavioural | Relaxation-group for adult ADHD |
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Moritz, Prof. principal investigator
UKE Hamburg
Peter Tonn, Dr. med. principal investigator
NPZ Hamburg
1 site in 1 country: see every site and its status.
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.