Predictors for successful treatment outcome in patients with comorbid attention-deficit/hyperactivity disorder (ADHD) and substance use disorder (SUD): an international observational cohort study
| ISRCTN | ISRCTN15998989 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15998989 |
- Submission date
- 20/12/2019
- Registration date
- 06/02/2020
- Last edited
- 17/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Patients with substance use disorder (SUD) are three to four times more likely to have attention deficit/hyperactivity disorder (ADHD) compared to the general population. Standard treatments for ADHD has not proven to be as effective in comorbid patients as in patients with ADHD only. There is currently a lack of knowledge of how to best treat patients with comorbid ADHD-SUD.
The purpose of this study is to gain more knowledge regarding treatments provided, and treatment outcome for patients with ADHD and substance use disorder. The study is observational and the aim is to describe the natural course of the disorders, and to identify factors that might predict a successful treatment result, i.e. retention to treatment and reduction in ADHD and SUD symptoms.
Who can participate?
This study will invite 600 adult (≥18 years) treatment seeking patients with comorbid ADHD and SUD.
What does the study involve?
Participants will be asked for informed consent to provide self-reported data at the start of treatment, and after 3 and 9 months, respectively. Data from the patient files will be collected, e g to confirm whether a patient is still in treatment or not.
What are the possible benefits and risks of participating?
This a naturalistic study, observational study and participation does not affect the participants treatment in any way. Participants will not receive any compensation.
Where is the study run from?
The study is a multicentre international study from different countries in Europe, USA and Australia.
When is the study starting and how long is it expected to run for?
The study is is anticipated to go on between June 2017 and May 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Christoffer Brynte
Physician, Stockholm Centre for Dependency Disorders
PhD student, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm
Christoffer.brynte@ki.se
Contact information
Scientific
Friskvårdsvägen 4, plan 2
S:t Göran
Stockholm
11281
Sweden
| Phone | +46 (0)8 123 400 00 |
|---|---|
| johan.franck@ki.se |
Study information
| Study design | Naturalistic multicenter observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | INCAS: International Naturalistic Cohort Study of ADHD and Substance Use Disorders Study |
| Study acronym | INCAS |
| Study objectives | The primary aim of the study is descriptive rather than hypothesis driven: To investigate the treatment modalitites provided to individuals with comorbid ADHD/SUD who are currently in treatment at SUD treatment services, and to identify predictors for successful treatment outcomes, as measured by retention, substance use and ADHD symptoms. |
| Ethics approval(s) | Approved 16/06/2017, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2017/973-32 |
| Health condition(s) or problem(s) studied | Attention deficit hyperactivity/impulsivity disorder with comorbid substance use disorder |
| Intervention | This study is non-interventional and investigates the treatment modalities provided to the study population at the participating treatment services. This study will invite 600 treatment-seeking patients from different countries in Europe, USA and Australia to participate for 9 months. Participants will be asked for informed consent to provide self-reported data at the start of treatment, and after 3 and 9 months, respectively. Data from the patient files will be collected, e.g. to confirm whether a patient is still in treatment or not. This a naturalistic study, observational study and participation does not affect the participants' treatment in any way. |
| Intervention type | Other |
| Primary outcome measure | 1. Retention to treatment, defined as time to drop-out (last contact between patient and treatment center) 2. ADHD symptoms measured using the Adult ADHD Self-Report Scale (ASRS) at 3 months follow-up 3. Number of days with heavy alcohol use or days with illicit drug use during the last 30 days, measured using the Time-Line Follow-Back instrument at 3 months follow-up |
| Secondary outcome measures | 1. ADHD symptoms measured using the adult ASRS at 9 months follow-up 2. Substance use measured with TLFB, defined as the number of days with heavy alcohol use or days with illicit drug use the last 30 days at 9 months follow-up. 3. ADHD symptoms according to the Expanded Adult ADHD Self-Report Scale at 3 and 9 months follow-up, respectively 4. Employment measured using questionnaire and patient files at baseline, 3 months and 9 months 5. Number of accidents as reported by the participant using questionnaire and patient files at baseline, 3 months and 9 months 6. Days with any alcohol use during the last 30 days measured using Timeline Follow-Back interview at baseline, 3 months and 9 months follow-up |
| Overall study start date | 01/07/2016 |
| Completion date | 31/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 578 |
| Key inclusion criteria | 1. Men and women ≥18 years of age seeking treatment for SUD at any of the participating sites 2. ADHD diagnosis according to DSM-5 3. SUD diagnosis (DSM-5 moderate to severe, ICD-10 dependence) |
| Key exclusion criteria | There are no formal exclusion criteria except incapability to complete the assessments |
| Date of first enrolment | 01/07/2017 |
| Date of final enrolment | 30/06/2021 |
Locations
Countries of recruitment
- Australia
- Belgium
- France
- Germany
- Hungary
- Netherlands
- Spain
- Sweden
- Switzerland
- United States of America
Study participating centres
Stockholm
112 81
Sweden
Antwerpen
2530 Boechout
Belgium
Budapest
1135
Hungary
Dordrecht
3329
Netherlands
3000 Bern 60
3000 Bern 60
Switzerland
Vught
5261 LX
Netherlands
Apeldoorn
7325 DZ
Netherlands
Sponsor information
Hospital/treatment centre
Friskvårdsvägen 4, plan 2
S:t Göran
Stockholm
11281
Sweden
| Phone | +46 (0)8 123 400 00 |
|---|---|
| johan.franck@ki.se | |
| Website | http://www.beroendecentrum.se/ |
"ROR" |
https://ror.org/04g380834 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results from the study will be published as soon as possible after the study is completed. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to regional data protection regulations. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 11/05/2021 | No | No | ||
| Protocol article | 23/09/2022 | 29/09/2022 | Yes | No | |
| Results article | 23/12/2024 | 17/01/2025 | Yes | No |
Additional files
- ISRCTN15998989_PROTOCOL.pdf
- Uploaded 11/05/2021
Editorial Notes
17/01/2025: Publication reference and total final enrolment added.
29/09/2022: Publication reference added.
11/05/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/03/2022 to 31/05/2022.
2. Uploaded protocol (not peer reviewed).
3. IPD sharing statement added.
02/01/2020: Trial’s existence confirmed by Swedish Ethical Review Authority.
