Effects of group therapy in treatment of ADHD in adults
| ISRCTN | ISRCTN30469893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30469893 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/02/2016
- Registration date
- 19/02/2016
- Last edited
- 29/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
A growing number of adults are diagnosed with Attention-Deficit Hyperactivity Disorder, or ADHD. People with ADHD can have problems in paying attention, feeling restless or hyperactive and behaving impulsively. Pharmacological (drug) treatments are well established, but a significant number of patients does not respond well or experience adverse effects, which results in them stopping the treatment. Furthermore many patients request for psychological treatment to help them with symptoms that are not resolved by simply taking drugs. There has been interest in looking at the potential effects of structured group therapy ,which has been useful to patients with other conditions. Some studies have shown that structured skills training groups are beneficial for adult sufferers of ADHD in outpatient psychiatric units, reducing ADHD symptoms in people who remained stable regarding their medication status. This study investigates the potential effects of structured skills training groups in a clinically relevant but still controlled setting, and whether they help alleviate symptoms and improve quality of life for adult ADHD sufferers.
Who can participate?
Adults that have been diagnosed with ADHD.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 have weekly active structured skills training group therapy sessions for 14 weeks, followed by their usual treatment for the reminder of the study. Those in group 2 are given their usual treatment, after which they are given 14 weeks of active structured skills training group therapy.
What are the possible benefits and risks of participating?
All patients taking part in this study will be offered an intensive and comprehensive psychological intervention with educational and supportive coaching for training in new mastery in their daily life. This is considered to be associated with significant opportunities for improvements and low risk for adverse effects. Patients will be followed up carefully so that any problems during treatment period could be detected early and dealt with in a clinically appropriate manner. All participants are then assessed in terms of whether their symptoms have improved.
Where is the study run from?
1. Haukeland University Hospital, Psychiatric Department (Norway)
2. Division of Mental Health and Addiction, Vestfold Hospital Trust (Norway)
3. Sørlandet Hospital, Kristiansand (Norway)
4. Stavanger University Hospital (Norway)
5. Østfold Hospital Trust (Norway)
When is the study starting and how long is it expected to run for?
June 2015 to December 2017
Who is funding the study?
1. Oslo University Hospital (Norway)
2. Haukeland University Hospital (Norway)
Who is the main contact?
1. Dr Anne Halmøy (scientific)
2. Dr Mats Fredriksen (scientific)
3. Mrs Bente Ubostad (public)
4. Ms Ellen Kathrine Munkhaugen (public)
Contact information
Scientific
Haukeland University Hospital
Psychiatric Department
Bergen
5021
Norway
Scientific
Division of Mental Health and Addiction
Vestfold Hospital Trust
Tønsberg
3101
Norway
 ORCID ID |
0000-0002-8392-3366 |
|---|
Public
Regional Competence Center for Neurodevelopmental Disorders and Hypersomnias
West Norway Regional Health Authority
Haukeland University Hospital
Bergen
5021
Norway
Public
Regional Competence Center for Autism
AD/HD,Tourettes Syndrome and Narcolepsy
South-Eastern Norway Regional Health Authority
Oslo University Hospital
Oslo
0424
Norway
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Available in Norwegian language |
| Scientific title | Effects of structured skills training group in treatment of ADHD in adults: a controlled multicentre study |
| Study objectives | The structured skills training group treatment is superior to the control condition 'treatment as usual' in reducing attention deficit hyperactivity disorder (ADHD) symptoms and functional deficits, and increasing quality of life in adults with ADHD. |
| Ethics approval(s) | Regional Committees for Medical Research Ethics - South East Norway, 29/10/2015, ref: 2015/1523 A |
| Health condition(s) or problem(s) studied | Attention deficit hyperactivity disorder |
| Intervention | Enrolled patients are randomised into two groups and allocated to either: 1. Group 1 (G1) with start of weekly treatment in active structured skills training group therapy lasting for 14 weeks, following the Norwegian translation of the Swedish version of the ADHD skills training manual/workbook (Hirvikoski 2011; Morgensterns 2015) based on an adaption of Marsha Linehan's dialectical behavior therapy (DBT) for borderline personality disorder. The groups embrace 7 - 10 participants, and two group leaders trained in group therapy, cognitive behavioral treatment or DBT. Each session contains an initial short repetition and feedback on the previous session, followed by review of the homework during the first hour. After a break, a new topic with exercises and homework for the following week is introduced. 2. Group 2 (G2) with treatment as usual/clinical management for the first 15 weeks, followed by delayed admission to the active intervention of structured skills training group therapy (partial cross-over) |
| Intervention type | Behavioural |
| Primary outcome measure | 1.Change in executive function impairments (total and separate dimensional scores) assessed by the self/informant-reports of adults aged Behavior Rating Inventory of Executive Function (BRIEF-A) at end of 14-weeks group treatment, and after 6 months post-treatment, compared to baseline and treatment as usual as control treatment strategy 2. Change in emotional regulation (total and separate dimensional scores) assessed by the self/informant-reports Difficulties in Emotion Regulation Scale (DERS) at end of 14-weeks group treatment, and after 6 months post-treatment, compared to baseline and treatment as usual as control treatment strategy |
| Secondary outcome measures | 1. Adult ADHD self-report scale (ASRS), the 18 items version 2. Beck Depression Inventory (BDI) 3. Beck Anxiety Inventory (BAI) 4. Alcohol Use Disorder Identification Test (AUDIT) 5. Drug Use Disorder Identification Test (DUDIT) 6. Weiss Functional Impairment Rating Scale, self-report (WIFRS) 7. Adult ADHD Quality of Life Scale (AAQoL) 8. Global Assessment of functioning (GAF) |
| Overall study start date | 22/06/2015 |
| Completion date | 15/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Between 100 - 120 |
| Total final enrolment | 121 |
| Key inclusion criteria | 1. Adults (age >= 18 years) 2. Both genders 3. Diagnosis of ADHD according to DSM-IV persisting in adulthood |
| Key exclusion criteria | 1. Any psychotic disorder 2. Recently suicidal behaviour 3. Substance or alcohol abuse or dependence within three months prior to screening for inclusion 4. Pervasive developmental disorder 5. Intellectual disability 6. Seizures or any neurological diseases causing mental handicap |
| Date of first enrolment | 14/02/2016 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Norway
Study participating centres
5021
Norway
3101
Norway
4604
Norway
4068
Norway
Norway
Sponsor information
Not defined
Regional Competence Center for Neurodevelopmental Disorders and Hypersomnias
Bergen
5021
Norway
| Phone | +47 55974594 |
|---|---|
| bente.ubostad@helse-bergen.no | |
| Website | http://www.helse-bergen.no/no/Sider/default.aspx |
"ROR" |
https://ror.org/03np4e098 |
Not defined
Regional Competence Center for Neurodevelopmental Disorders and Hypersomnias
South-Eastern Norway Regional Health Authority
Pb 4956 Nydalen
Oslo
0424
Norway
| Phone | +47 22 11 80 96 |
|---|---|
| ellmun@ous-hf.no | |
| Website | http://www.oslo-universitetssykehus.no/om-oss/english |
|
"ROR" |
https://ror.org/00j9c2840 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Intention to publish data and results from the study in peer-reviewed journals |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 29/10/2015 | 01/09/2022 | No | No | |
| Results article | 28/11/2022 | 29/11/2022 | Yes | No |
Additional files
Editorial Notes
29/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
01/09/2022: The protocol (not peer reviewed) has been uploaded as an additional file.
15/01/2019: The intention to publish date has been changed from 31/12/2017 to 31/12/2019.
19/12/2018: The overall trial end date has been changed from 31/12/2017 to 15/05/2018.
18/10/2017: Internal review.
