Condition category
Mental and Behavioural Disorders
Date applied
29/06/2012
Date assigned
31/07/2012
Last edited
23/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a mental disorder with symptoms including inattentiveness, hyperactivity and impulsiveness. The symptoms usually improve with age, but many adults continue to experience problems. This study focuses on the effects of two types of psychotherapy for the treatment of adult ADHD. The goal is to assess the effectiveness of a mindfulness-based psychotherapy and compare it to the effectiveness of a psychoeducative psychotherapy.

Who can participate?
Patients aged 18 to 65 with ADHD

What does the study involve?
During the first week of the study, participants complete questionnaires assessing their ADHD symptoms and undergo MRI scans. Over the course of next 8 weeks, participants are randomly allocated to take part in either weekly mindfulness-based psychotherapy or weekly psychoeducative group therapy. After 8 weeks participants complete the questionnaires and undergo MRI scans again. Participants are followed up again after 8 months.

What are the possible benefits and risks of participating?
Potential benefits include the positive effects of psychotherapy specifically for ADHD. Possible risks include side effects of psychotherapy, such as added stress in confronting their symptoms.

Where is the study run from?
University Hospital of Freiburg (Germany)

When is study starting and how long is it expected to run for?
September 2012 to September 2013

Who is funding the study?
University Hospital of Freiburg (Germany)

Who is the main contact?
Dr Alexandra Philipsen

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexandra Philipsen

ORCID ID

Contact details

Universitätsklinikum Freiburg
Abteilung für Psychiatrie und Psychotherapie
Hauptstr. 5
Freiburg
79104
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparing the effects of mindfulness-based cognitive therapy and psychoeducational therapy on symptomatology and neurophysiological correlates of adult ADHD: a randomized controlled trial

Acronym

Study hypothesis

1. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show a decrease in the severity of their ADHD symptomatology after treatment in comparison with ADHD symptomatology before treatment.
2. Participants in psychoeducative group therapy for adult ADHD (D’Amelio, Retz, Philipsen, & Rösler, 2009) will show a decrease in the severity of their ADHD symptomatology after treatment in comparison with ADHD symptomatology before treatment.
3. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) and participants in psychoeducative group therapy (D’Amelio, Retz, Philipsen & Rösler, 2009) will not differ from one another before study treatment with regard to their ADHD symptatomology. After the therapy, participants in mindfulness-based group therapy (Zylowska et. al 2008) will show a greater decrease in the severity of their ADHD symptomatology in comparison with participants in psychoeducative group therapy (D’Amelio, Retz, Philipsen & Rösler, 2009).
4. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al, 2008) and participants in psychoeducative group psychotherapy will not differ from one another regarding the activation of the caudate nucleus during a Go/no-go task before treatment. After treatment, participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show higher activation in the caudate nucleus during a Go/no-go task in comparison with participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009).
5. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) and participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009) will not differ from one another before the study treatment in regards to the activation of the default-mode network. After the therapy, participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show lower activation of the default-mode network during the task in comparison with participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009).
6. Participants in mindfulness-based group psychotherapy for adult ADHD by Zylowska et al. (2008) will show higher mindfulness scores after the study treatment in comparison to mindfulness scores before the beginning of the study treatment.
7. Participants in psychoeducative group psychotherapy by D’Amelio, Retz, Philipsen & Rösler (2009) will not differ before and after the study treatment with regards to self-assessed mindfulness scores.
8. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) and participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009) will not differ from each other before the study treatment with regards to their self-assessed mindfulness. After the therapy, the participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show higher self-assessed mindfulness scores than participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009).
9. Participants in mindfulness-based group psychotherapy for adult ADHD by Zylowska et al. (2008) will show lower general psychopathology after the study treatment than before the study treatment.
10. Participants in psychoeducative group psychotherapy for adult ADHD by D’Amelio, Retz, Philipsen & Rösler (2009) will show lower general psychopathology after treatment than before the study treatment.
11. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) and participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009) will not differ from each other before the study treatment with regards to the characteristic of their general psychopathology. After the therapy the participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show lower general psychopathology than participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009).
12. Participants in mindfulness-based group psychotherapy for adult ADHD by Zylowska et al. (2008) will show higher quality of life after study treatment than before study treatment.
13. Participants in psychoeducative group psychotherapy for adult ADHD by D’Amelio, Retz, Philipsen &Rösler (2009) will show higher quality of life after study treatment than before study treatment.
14. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) and participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009) will not differ from each other before the study treatment with regards to self-assessed quality of life. After the therapy the participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show higher self-assessed quality of life than participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009).
15. Participants in mindfulness-based group psychotherapy for adult ADHD by Zylowska et al. (2008) will show lower severity of depression after study treatment than before study treatment.
16. Participants in psychoeducative group psychotherapy for adult ADHD by D’Amelio, Retz, Philipsen &Rösler (2009) will show lower severity of depression after study treatment than before study treatment.
17. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) and participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009) will not differ from each other before the study treatment with regards to severity of depression. After the therapy the participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show lower severity of depression than participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009).
18. Participants in mindfulness-based group psychotherapy for adult ADHD by Zylowska et al. (2008) will show lower nicotine dependence after study treatment than before study treatment.
19. Participants in psychoeducative group psychotherapy for adult ADHD by D’Amelio, Retz, Philipsen & Rösler (2009) will show lower nicotine dependence after study treatment than before study treatment.
20. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) and participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009) will not differ from each other before the study treatment with regards to nicotine dependence. After the therapy the participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show lower nicotine dependence than participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009).
21. Participants in mindfulness-based group psychotherapy for adult ADHD by Zylowska et al. (2008) will show lower caffeine consumption after study treatment than before study treatment.
22. Participants in psychoeducative group psychotherapy for adult ADHD by D’Amelio, Retz, Philipsen &Rösler (2009) will show lower caffeine consumption after study treatment than before study treatment.
23. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) and participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009) will not differ from each other before the study treatment with regards to caffeine consumption. After the therapy the participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show lower caffeine consumption than participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009).
24. Participants in mindfulness-based group psychotherapy for adult ADHD by Zylowska et al. (2008) will show a lesser degree of behavioral addiction after study treatment than before study treatment.
25. Participants in psychoeducative group psychotherapy for adult ADHD by D’Amelio, Retz, Philipsen &Rösler (2009) will show a lesser degree of behavioral addiction after study treatment than before study treatment.
26. Participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) and participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009) will not differ from each other before the study treatment with regards to behavioral addiction. After the therapy the participants in mindfulness-based group psychotherapy for adult ADHD (Zylowska et al., 2008) will show lesser degree of behavioral addiction than participants in psychoeducative group psychotherapy (D’Amelio, Retz, Philipsen & Rösler, 2009).

Ethics approval

Ethics commission of the Albert-Ludwigs-University Freiburg (Ethik-Kommision of the Albert-Ludwigs-Universität Freiburg), 18/06/2012, ref: 240/12

Study design

Randomized 2x3 factorial design investigators blind to patient group membership

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Adult attention deficit hyperactivity disorder (ADHD)

Intervention

Intervention 1: Mindfulness-based group psychotherapy for adult ADHD
Duration: 8 weekly meetings, lasting 2.5 hours each

Intervention 2: Psychoeducative group psychotherapy for adult ADHD
Duration: 8 weekly meetings, lasting 2.5 hours each

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. ADHD symptomatology, measured using Conners Adult ADHD Rating Scale-Observer [Inattention Scale (A) and Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) ADHD- Overall Symptoms (G)] in week 0, week 8, and month 8
2. Neurobiological correlates: activity in caudate nucleus measured using functional magnetic resonance imaging (fMRI) in week 0, week 8, and month 8

Secondary outcome measures

1. Severity of depression, measured using Beck Depression Inventory II in week 0, week 8, and month 8
2. General psychpathology, measured using Symptom Check List- 90- revised in week 0, week 8, and month 8
3. Quality of life, measured using the German version of Short-Form 36 questionnaire in week 0, week 8, and month 8
4. Mindfulness, measured using the Five-Facet Mindfulness Questionnaire in week 0, week 8, and month 8
5. Nicotine dependence, measured using Fagerström Nicotine Dependence Test in week 0, week 8, and month 8
6. Caffeine consumption, recorded through single item in blind external assessment in week 0, week 8, and month 8
7. Extent of behavioral addiction, recorded through single item in blind external assessment in week 0, week 8, and month 8

Overall trial start date

15/09/2012

Overall trial end date

15/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women
2. First language German or comparable level
3. At least 18 years old, at most 65 years old
4. Diagnosed with ADHD (through a doctor or psychologist)
5. Wender Utah Rating Scale (WURS)-Score of at least 30
6. Subject’s consent in written form
7. Unlimited legal competency

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 total participants

Participant exclusion criteria

1. Following diagnoses: schizophrenia, bipolar disorder, antisocial personality disorder, borderline personality disorder, pervasive developmental disorder/autism, Tourette syndrome, alcohol or drug addiction (misuse, abuse)
2. Suicidality or self-harm
3. Body-Mass Index under 19
4. Pregnancy (first trimester)
5. Metallic implants in body
6. Tattoos
7. Claustrophobia (ICD 10 F40.2)
8. Past or current presence of neurological disease: stroke, epilepsy, dementia
9. Current taking methylphenidate and/or other stimulants
10. Participation in other psychotherapy during the 3 months prior to study treatment
11. Evidence of below-average intelligence measured using the Multiple choice vocabulary intelligence test (Mehrfachwahl-Wortschatz-Intelligenztest) (MWT-B)
12. Patient incapable of acting under law

Recruitment start date

15/09/2012

Recruitment end date

15/09/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsklinikum Freiburg
Freiburg
79104
Germany

Sponsor information

Organisation

University Hospital of Freiburg (Universitätsklinikum Freiburg) (Germany)

Sponsor details

c/o Dr Alexandra Philipsen
MD
Abteilung für Psychiatrie und Psychotherapie
Hauptstr. 5
Freiburg
79104
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Freiburg (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/05/2017: Plain English summary added.