MAC-cbt Group Therapy for Adults With ADHD

NCT ID: NCT03806569

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Psychotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

monocentric, parallel group randomized superiority study - one arm with new intervention, other arm with well established relaxation treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The participants will not know, in which of the arms they are; the outcomes assessor did not know the patients study-arm

Study Groups

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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"

Group Type ACTIVE_COMPARATOR

MAC-cbt group treatment for adult ADHD

Intervention Type BEHAVIORAL

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.

Relaxation-group for adult ADHD

The patients will be treated with a relaxation-treatment, long-time established as "Jacobson muscle relaxing technique".

Group Type SHAM_COMPARATOR

Jacobson

Intervention Type BEHAVIORAL

Relaxation treatment in technique of Jacobson in 8 sessions

Interventions

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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.

Intervention Type BEHAVIORAL

Jacobson

Relaxation treatment in technique of Jacobson in 8 sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

Peter Tonn

OTHER

Sponsor Role lead

Responsible Party

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Peter Tonn

Director of the Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Steffen Moritz, Prof.

Role: PRINCIPAL_INVESTIGATOR

UKE Hamburg

Peter Tonn, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

NPZ Hamburg

Locations

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Neuropsychiatric Center of Hamburg

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Peter Tonn, Dr. med.

Role: CONTACT

+494053307380

Steffen Moritz, Prof.

Role: CONTACT

+49 (40) 7410-56565

Facility Contacts

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Nina Schulze, MoS

Role: primary

+494053307380

Other Identifiers

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KUCHLER_2018

Identifier Type: -

Identifier Source: org_study_id

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