Clinical trial NCT03806569: MAC-cbt Group Therapy for Adults With ADHD
Official title: Mindfulness-Based Behavioural Group Therapy for Adult Attention Deficit Hyperactivity Disorder - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotherapy
Keywords: cognitive behavioral therapy
mindfulness
acceptance
commitment
adult ADHD
Lead sponsor: Neuropsychiatrischen Zentrums Hamburg-Altona
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2019-01-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: monocentric, parallel group randomized superiority study - one arm with new intervention, other arm with well established relaxation treatment
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change of Symptoms measured by the Connors ADHD Adult Rating Scale (CAARS)
timeFrame: 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:
measure: Measure of the quality of life of the participants measured by World Health Organization Quality of Life Questionnaire
timeFrame: 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
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)
timeFrame: 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
measure: Changes of mindfulness measured by Mindful Attention Awareness Scale
timeFrame: 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
measure: Changes of acceptance, measured by Acceptance and Action Questionnaire
timeFrame: 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
measure: Affective state measured with the Patient Health Questionnaire PHQ-9
timeFrame: 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
measure: Measuring of satisfaction and willingness to change with visual analogue scales
timeFrame: 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
measure: Measuring of five individual parameters during every of the single treatment session
timeFrame: Measurement before and after every treatment session, 2-6 weeks after inclusion date, every week for the 8 weeks treatment period
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Neuropsychiatric Center of Hamburg
Study officials:
affiliation: UKE Hamburg
name: Steffen Moritz, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: NPZ Hamburg
name: Peter Tonn, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: