Effects and mechanisms of psychotherapy in the treatment of attention deficit hyperactivity disorder in adults: the first randomised multicentre study
| ISRCTN | ISRCTN54096201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54096201 |
| EudraCT/CTIS number | 2006-000222-31 |
| Secondary identifying numbers | Code: 070170 |
- Submission date
- 19/10/2006
- Registration date
- 30/04/2007
- Last edited
- 23/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alexandra Philipsen
Scientific
Scientific
Hauptstrasse 5
Freiburg
D-79104
Germany
Study information
| Study design | Controlled randomised multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects and mechanisms of psychotherapy in the treatment of attention deficit hyperactivity disorder in adults: the first randomised multicentre study |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 448 |
| Total final enrolment | 433 |
| Key inclusion criteria | ADHD according to the Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) criteria |
| Key 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 |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 31/10/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Hauptstrasse 5
Freiburg
D-79104
Germany
D-79104
Germany
Sponsor information
University of Freiburg Medical School (Germany)
University/education
University/education
Hauptstrasse 5
Freiburg
D-79104
Germany
| Website | http://www.uniklinik-freiburg.de/ims/live/index_en.html |
|---|---|
"ROR" |
https://ror.org/0245cg223 |
Funders
Funder type
Government
Bundesministerium für Bildung und Forschung
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/12/2010 | Yes | No | |
| Other publications | enrollment and characteristics of the study sample | 01/03/2014 | Yes | No | |
| Results article | results | 01/12/2015 | Yes | No | |
| Results article | results | 03/05/2019 | 04/09/2019 | Yes | No |
| Results article | results | 01/07/2019 | 04/09/2019 | Yes | No |
| Results article | 01/04/2022 | 03/05/2022 | Yes | No | |
| Results article | 18/11/2023 | 23/11/2023 | Yes | No |
Editorial Notes
23/11/2023: Publication reference added.
03/05/2022: Publication reference added.
04/09/2019: The following changes were made to the trial record:
1. Publication references added.
2. The total final enrolment was added.
