MAC-cbt Group Therapy for Adults With ADHD

Peter Tonn

Status: Unknown

Conditions: Psychotherapy

Treatments: Behavioral: MAC-cbt group treatment for adult ADHD; Behavioral: Jacobson

Study type: Interventional

Funder types: Other

Identifiers

NCT03806569

KUCHLER_2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups

MAC-cbt group treatment for adult ADHD

Active Comparator group

Description:

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"

Treatment:

Behavioral: MAC-cbt group treatment for adult ADHD

Relaxation-group for adult ADHD

Sham Comparator group

Description:

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

Treatment:

Behavioral: Jacobson