Effects and mechanisms of psychotherapy in the treatment of attention deficit hyperactivity disorder in adults: the first randomised multicentre study

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Dr Alexandra Philipsen

ORCID ID

Contact details

Hauptstrasse 5
Freiburg
D-79104
Germany

EudraCT/CTIS number

2006-000222-31

IRAS number

ClinicalTrials.gov number

Protocol/serial number

Code: 070170

Scientific title

Effects and mechanisms of psychotherapy in the treatment of attention deficit hyperactivity disorder in adults: the first randomised multicentre study

Acronym

Study hypothesis

1. A disorder specific psychotherapy is more effective in reducing symptoms of adult Attention Deficit Hyperactivity Disorder (ADHD) than a control condition in terms of clinical management
2. The combination of a disorder specific psychotherapy and medication is superior to medication or psychotherapy alone

Ethics approval(s)

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg, 19/10/2006, ref: 217/06

Study design

Controlled randomised multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

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

Condition

Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

Experimental intervention:
1. Psychotherapy following a weekly structured group-program for 12 weeks (according to Hesslinger et. al.) and placebo and after that monthly group sessions and placebo
2. Psychotherapy (see point one) and medication (methylphenidate, according to the German guidelines for adult ADHD)

Control intervention:
3. Medication alone with clinical management weekly for the first 12 weeks and monthly thereafter
4. Placebo alone with clinical management weekly for the first 12 weeks and monthly thereafter

Intervention type

Drug

Pharmaceutical study type(s)

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

Methylphenidate

Primary outcome measure

Conners Adult ADHD Rating Scale (CAARS-O, blind-observer rated).

Secondary outcome measures

1. Conners Adult ADHD Rating Scale (CAARS-S, patient rated)
2. Symptoms CheckList (SCL-90-R)
3. Depression
4. Clinical Global Impression (CGI)
5. Quality of Life

Overall study start date

01/11/2006

Overall study end date

31/10/2011

Reason abandoned (if study stopped)

Participant inclusion criteria

ADHD according to the Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) criteria

Participant type(s)

Patient

Age group

Adult

Sex

Both

Target number of participants

448

Total final enrolment

433

Participant exclusion criteria

1. Mental handicap
2. Schizophrenia
3. Bipolar disorder
4. Suicidal behaviour
5. Substance abuse/dependence within six months prior to screening
6. Neurological diseases
7. Seizures

Recruitment start date

01/11/2006

Recruitment end date

31/10/2011

Countries of recruitment

Germany

Study participating centre

Hauptstrasse 5
Freiburg
D-79104
Germany

Organisation

University of Freiburg Medical School (Germany)

Sponsor details

Hauptstrasse 5
Freiburg
D-79104
Germany

Sponsor type

University/education

Website

http://www.uniklinik-freiburg.de/ims/live/index_en.html

ROR

https://ror.org/0245cg223

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Germany

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

Not provided at time of registration

IPD sharing plan summary

Not provided at time of registration

Study outputs