MAC-cbt Group Therapy for Adults With ADHD

NCT03806569 | Unknown

• 1 other identifier: KUCHLER_2018
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotherapy

Keywords

cognitive behavioral therapy; mindfulness; acceptance; commitment; adult ADHD

Outcome Measures

Primary Outcomes (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.

  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

  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)

  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

  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

  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

  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

Study Arms (2)

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"

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".

Behavioral: Jacobson

Interventions

MAC-cbt group treatment for adult ADHD 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.

MAC-cbt group treatment for adult ADHD

Jacobson BEHAVIORAL

Relaxation treatment in technique of Jacobson in 8 sessions

Relaxation-group for adult ADHD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter Tonn: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

Neuropsychiatric Center of Hamburg

Hamburg, 22769, Germany

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Steffen Moritz, Prof.

  UKE Hamburg

  PRINCIPAL INVESTIGATOR

• Peter Tonn, Dr. med.

  NPZ Hamburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Tonn, Dr. med.

CONTACT

+494053307380; tonn@npz-hamburg.de

Steffen Moritz, Prof.

CONTACT

+49 (40) 7410-56565; moritz@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants will not know, in which of the arms they are; the outcomes assessor did not know the patients study-arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Center

Model Details: monocentric, parallel group randomized superiority study - one arm with new intervention, other arm with well established relaxation treatment

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: March 1, 2019
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)