Attention Deficit Hyperactivity Disorder (ADHD)NCT02685254
Effects of Structured Skills Training Group in Treatment of ADHD in Adults
A study testing Structural skills training group and Treatment as usual in people with Attention Deficit Hyperactivity Disorder (ADHD), run by University of Oslo at 1 site in Norway.
Trial summary
This study aims to examine if structured skills training group therapy for ADHD in adults has beneficial effects superior to 'treatment as usual' including medication in a controlled outpatient setting on clinically relevant outcomes including symptoms, functioning and quality of life measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Structural skills training group and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2016to 15 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) persisting in adulthood
Who cannot join
- Any psychotic disorder
- Recently suicidal behaviour
- Substance or alcohol abuse or dependence within three months prior to screening for inclusion
- Pervasive developmental disorder
- Intellectual disability
- Seizures or any neurological diseases causing mental handicap
Trial locations and contacts
1 site in 1 country.
Norway1 site
Division of Mental Health and Addiction, Vestfold Hospital Trust
Tønsberg, 3103
About this study
Official title: Effects of Structured Skills Training Group in Treatment of ADHD in Adults: a Controlled Multicentre Study
This study aims to examine if structured skills training group therapy for ADHD in adults has beneficial effects superior to 'treatment as usual' including medication in a controlled outpatient setting on clinically relevant outcomes including symptoms, functioning and quality of life measures.
The trial is designed as a multicenter randomized controlled, parallel group study. Patients are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial intervention by structured skills training groups by weekly sessions or one with control condition (treatment as usual). Then after 15 weeks patients in the control condition arm are switched to the active intervention by 14 weeks of structured group therapy. All patients are assessed for defined outcomes after six months.
Read the detailed description
Background: The focus in recent years on evidence for non-pharmacological treatment in adults with ADHD raises the question of potential effects of structured group therapy. Structured skills training groups have shown beneficial effects in some studies in an outpatient psychiatric context by reduction in ADHD symptoms in individuals who remained stable regarding medication status.
Aims: The main objective for the trial is to investigate the potential effects of structured skills training groups in a clinically relevant but still controlled setting on broader outcomes including both symptomatic, functional and health related quality of life measures.
Methods/Design: The trial is designed as a multicenter randomized controlled parallel group design. At each outpatient site the enrolled patients are randomized into two groups for either Group 1 (G1) with start of weekly treatment in active structured skills training group lasting for 14 weeks or allocated to Group 2 (G2) with treatment as usual/clinical management and with 15 weeks delayed start of their group treatment for comparison wth patients in the other arm. Those patients in the control condition arm receiving treatment as usual or clinical management of individual patients (G2), are thereafter switched to active structured skills training group therapy.All patients are followed up after six months with assessments of primary and secondary outcomes.
- Being tested
- Structural skills training group, Treatment as usual
- Keywords
- Group Therapy, Structured Skills Training, Dialectic Behavioural Therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural skills training groupBehavioural
Also called Dialectic behavioural group therapy
Weekly 2-hours sessions for 14 weeks follow the Norwegian translation of the Swedish version of the ADHD skills training manual/workbook (Hesslinger 2010; Hirvikoski 2011; Morgensterns 2015) which is based on an adaption of Marsha Linehan's dialectical behavior therapy (DBT) for borderline personality disorder into a group-based skills training program for adults with ADHD (Hesslinger 2002; Philipsen 2007). 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.
Treatment as usualOther
Treatment as usual includes clinical management and/or medication, and or supportive counselling by physician or nurse
| Study group | Role | What they receive |
|---|---|---|
| Initial group therapy | Experimental | 'Structural skills training group' - Start up with weekly structured skills training group for 14 weeks supplemented by homework training Receives: Behavioral: Structural skills training group |
| Initial control condition | Other | Treatment as usual/clinical management the first 15 weeks pending deferred start of group therapy (partially cross-over) Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviour Rating Inventory of Executive Functions (BRIEF)
Change in executive function impairments
Measured: two years
Secondary outcomes (8)
Adult ADHD self-report scale (ASRSv1.1), 18 items version
Change in ADHD symptoms
Measured: two years
Beck Depression Inventory (BDI)
Change in depressive symptoms
Measured: two years
Beck Anxiety Inventory (BAI)
Change in anxiety symptoms
Measured: two years
Weiss Functional Impairment Rating Scale, self-report (WIFRS)
Change in functional impairments
Measured: two years
Global Assessment of functioning (GAF)
Change in global symptoms and functioning
Measured: two years
Adult ADHD Quality of Life Scale (AAQoL)
Change in quality of life
Measured: two years
Difficulties in Emotion Regulation Scale (DERS)
Change in emotional regulation
Measured: two years
Safety issue - Monitoring of adverse events
Monitoring of adverse events
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion30 Apr 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Oslo University Hospital, The Hospital of Vestfold
- Responsible party
- Principal investigator, Mats Fredriksen, University of Oslo
- Investigators
- Ellen K Munkhaugen, MSED, Study director, Hospital of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685254
- Sponsor's protocol ID
- 2015/1523 A
- Status last verified
- May 2018
- First submitted
- 12 Feb 2016
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data from each site will be anonymised in the final analyses
Publications
Philipsen A, Richter H, Peters J, Alm B, Sobanski E, Colla M, Munzebrock M, Scheel C, Jacob C, Perlov E, Tebartz van Elst L, Hesslinger B. Structured group psychotherapy in adults with attention deficit hyperactivity disorder: results of an open multicentre study. J Nerv Ment Dis. 2007 Dec;195(12):1013-9. doi: 10.1097/NMD.0b013e31815c088b.
PubMed 18091195Philipsen A, Graf E, Jans T, Matthies S, Borel P, Colla M, Gentschow L, Langner D, Jacob C, Gross-Lesch S, Sobanski E, Alm B, Schumacher-Stien M, Roesler M, Retz W, Retz-Junginger P, Kis B, Abdel-Hamid M, Heinrich V, Huss M, Kornmann C, Burger A, van Elst LT, Berger M. A randomized controlled multicenter trial on the multimodal treatment of adult attention-deficit hyperactivity disorder: enrollment and characteristics of the study sample. Atten Defic Hyperact Disord. 2014 Mar;6(1):35-47. doi: 10.1007/s12402-013-0120-z. Epub 2013 Oct 17.
PubMed 24132867Philipsen A, Jans T, Graf E, Matthies S, Borel P, Colla M, Gentschow L, Langner D, Jacob C, Gross-Lesch S, Sobanski E, Alm B, Schumacher-Stien M, Roesler M, Retz W, Retz-Junginger P, Kis B, Abdel-Hamid M, Heinrich V, Huss M, Kornmann C, Burger A, Perlov E, Ihorst G, Schlander M, Berger M, Tebartz van Elst L; Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS) Consortium. Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1199-210. doi: 10.1001/jamapsychiatry.2015.2146.
PubMed 26536057Hirvikoski T, Waaler E, Alfredsson J, Pihlgren C, Holmstrom A, Johnson A, Ruck J, Wiwe C, Bothen P, Nordstrom AL. Reduced ADHD symptoms in adults with ADHD after structured skills training group: results from a randomized controlled trial. Behav Res Ther. 2011 Mar;49(3):175-85. doi: 10.1016/j.brat.2011.01.001. Epub 2011 Jan 14.
PubMed 21295767Morgensterns E, Alfredsson J, Hirvikoski T. Structured skills training for adults with ADHD in an outpatient psychiatric context: an open feasibility trial. Atten Defic Hyperact Disord. 2016 Jun;8(2):101-11. doi: 10.1007/s12402-015-0182-1. Epub 2015 Sep 26.
PubMed 26410823Hesslinger B, Tebartz van Elst L, Nyberg E, Dykierek P, Richter H, Berner M, Ebert D. Psychotherapy of attention deficit hyperactivity disorder in adults--a pilot study using a structured skills training program. Eur Arch Psychiatry Clin Neurosci. 2002 Aug;252(4):177-84. doi: 10.1007/s00406-002-0379-0.
PubMed 12242579Halmoy A, Ring AE, Gjestad R, Moller M, Ubostad B, Lien T, Munkhaugen EK, Fredriksen M. Dialectical behavioral therapy-based group treatment versus treatment as usual for adults with attention-deficit hyperactivity disorder: a multicenter randomized controlled trial. BMC Psychiatry. 2022 Nov 28;22(1):738. doi: 10.1186/s12888-022-04356-6.
PubMed 36443712
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Structured Skills Training Group in Treatment of ADHD in Adults: a Controlled Multicentre Study
- ClinicalTrials.gov ID
- NCT02685254
- Acronym / sponsor ID
- 2015/1523 A
- Keywords
- Group Therapy, Structured Skills Training, Dialectic Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Oslo University Hospital, The Hospital of Vestfold
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine if structured skills training group therapy for ADHD in adults has beneficial effects superior to 'treatment as usual' including medication in a controlled outpatient setting on clinically relevant outcomes including symptoms, functioning and quality of life measures.
The trial is designed as a multicenter randomized controlled, parallel group study. Patients are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial intervention by structured skills training groups by weekly sessions or one with control condition (treatment as usual). Then after 15 weeks patients in the control condition arm are switched to the active intervention by 14 weeks of structured group therapy. All patients are assessed for defined outcomes after six months.
Detailed description
Background: The focus in recent years on evidence for non-pharmacological treatment in adults with ADHD raises the question of potential effects of structured group therapy. Structured skills training groups have shown beneficial effects in some studies in an outpatient psychiatric context by reduction in ADHD symptoms in individuals who remained stable regarding medication status.
Aims: The main objective for the trial is to investigate the potential effects of structured skills training groups in a clinically relevant but still controlled setting on broader outcomes including both symptomatic, functional and health related quality of life measures.
Methods/Design: The trial is designed as a multicenter randomized controlled parallel group design. At each outpatient site the enrolled patients are randomized into two groups for either Group 1 (G1) with start of weekly treatment in active structured skills training group lasting for 14 weeks or allocated to Group 2 (G2) with treatment as usual/clinical management and with 15 weeks delayed start of their group treatment for comparison wth patients in the other arm. Those patients in the control condition arm receiving treatment as usual or clinical management of individual patients (G2), are thereafter switched to active structured skills training group therapy.All patients are followed up after six months with assessments of primary and secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial group therapy | Experimental | Behavioral: Structural skills training group'Structural skills training group' - Start up with weekly structured skills training group for 14 weeks supplemented by homework training |
| Initial control condition | Other | Other: Treatment as usualTreatment as usual/clinical management the first 15 weeks pending deferred start of group therapy (partially cross-over) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) persisting in adulthood
Key exclusion criteria (6 listed)
- Any psychotic disorder
- Recently suicidal behaviour
- Substance or alcohol abuse or dependence within three months prior to screening for inclusion
- Pervasive developmental disorder
- Intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural skills training groupAlso: Dialectic behavioural group therapyWeekly 2-hours sessions for 14 weeks follow the Norwegian translation of the Swedish version of the ADHD skills training manual/workbook (Hesslinger 2010; Hirvikoski 2011; Morgensterns 2015) which is based on an adaption of Marsha Linehan's dialectical behavior therapy (DBT) for borderline personality disorder into a group-based skills training program for adults with ADHD (Hesslinger 2002; Philipsen 2007). 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. | Behavioural | Initial group therapy |
| Treatment as usualTreatment as usual includes clinical management and/or medication, and or supportive counselling by physician or nurse | Other | Initial control condition |
Primary outcome
Behaviour Rating Inventory of Executive Functions (BRIEF)
Time frame: two years
Change in executive function impairments
8 secondary outcomes
Adult ADHD self-report scale (ASRSv1.1), 18 items version
Time frame: two years
Beck Depression Inventory (BDI)
Time frame: two years
Beck Anxiety Inventory (BAI)
Time frame: two years
Weiss Functional Impairment Rating Scale, self-report (WIFRS)
Time frame: two years
Global Assessment of functioning (GAF)
Time frame: two years
Adult ADHD Quality of Life Scale (AAQoL)
Time frame: two years
Difficulties in Emotion Regulation Scale (DERS)
Time frame: two years
Safety issue - Monitoring of adverse events
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Background: PubMed 18091195Philipsen A, Richter H, Peters J, Alm B, Sobanski E, Colla M, Munzebrock M, Scheel C, Jacob C, Perlov E, Tebartz van Elst L, Hesslinger B. Structured group psychotherapy in adults with attention deficit hyperactivity disorder: results of an open multicentre study. J Nerv Ment Dis. 2007 Dec;195(12):1013-9. doi: 10.1097/NMD.0b013e31815c088b.
- Background: PubMed 24132867Philipsen A, Graf E, Jans T, Matthies S, Borel P, Colla M, Gentschow L, Langner D, Jacob C, Gross-Lesch S, Sobanski E, Alm B, Schumacher-Stien M, Roesler M, Retz W, Retz-Junginger P, Kis B, Abdel-Hamid M, Heinrich V, Huss M, Kornmann C, Burger A, van Elst LT, Berger M. A randomized controlled multicenter trial on the multimodal treatment of adult attention-deficit hyperactivity disorder: enrollment and characteristics of the study sample. Atten Defic Hyperact Disord. 2014 Mar;6(1):35-47. doi: 10.1007/s12402-013-0120-z. Epub 2013 Oct 17.
- Background: PubMed 26536057Philipsen A, Jans T, Graf E, Matthies S, Borel P, Colla M, Gentschow L, Langner D, Jacob C, Gross-Lesch S, Sobanski E, Alm B, Schumacher-Stien M, Roesler M, Retz W, Retz-Junginger P, Kis B, Abdel-Hamid M, Heinrich V, Huss M, Kornmann C, Burger A, Perlov E, Ihorst G, Schlander M, Berger M, Tebartz van Elst L; Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS) Consortium. Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1199-210. doi: 10.1001/jamapsychiatry.2015.2146.
- Background: PubMed 21295767Hirvikoski T, Waaler E, Alfredsson J, Pihlgren C, Holmstrom A, Johnson A, Ruck J, Wiwe C, Bothen P, Nordstrom AL. Reduced ADHD symptoms in adults with ADHD after structured skills training group: results from a randomized controlled trial. Behav Res Ther. 2011 Mar;49(3):175-85. doi: 10.1016/j.brat.2011.01.001. Epub 2011 Jan 14.
- Background: PubMed 26410823Morgensterns E, Alfredsson J, Hirvikoski T. Structured skills training for adults with ADHD in an outpatient psychiatric context: an open feasibility trial. Atten Defic Hyperact Disord. 2016 Jun;8(2):101-11. doi: 10.1007/s12402-015-0182-1. Epub 2015 Sep 26.
- Background: PubMed 12242579Hesslinger B, Tebartz van Elst L, Nyberg E, Dykierek P, Richter H, Berner M, Ebert D. Psychotherapy of attention deficit hyperactivity disorder in adults--a pilot study using a structured skills training program. Eur Arch Psychiatry Clin Neurosci. 2002 Aug;252(4):177-84. doi: 10.1007/s00406-002-0379-0.
- Derived from this study: PubMed 36443712Halmoy A, Ring AE, Gjestad R, Moller M, Ubostad B, Lien T, Munkhaugen EK, Fredriksen M. Dialectical behavioral therapy-based group treatment versus treatment as usual for adults with attention-deficit hyperactivity disorder: a multicenter randomized controlled trial. BMC Psychiatry. 2022 Nov 28;22(1):738. doi: 10.1186/s12888-022-04356-6.
- Individual participant dataSharing planned: No. Data from each site will be anonymised in the final analyses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen K Munkhaugen, MSED study director
Hospital of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structural skills training group and Treatment as usual in people with Attention Deficit Hyperactivity Disorder (ADHD), run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behaviour Rating Inventory of Executive Functions (BRIEF) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02685254, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.