Clinical trial NCT02685254: Effects of Structured Skills Training Group in Treatment of ADHD in Adults
Official title: Effects of Structured Skills Training Group in Treatment of ADHD in Adults: a Controlled Multicentre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Group Therapy
Structured Skills Training
Dialectic Behavioural Therapy
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Oslo University Hospital
name: The Hospital of Vestfold
First posted: 2016-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) persisting in adulthood

Exclusion Criteria:

* 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

Primary outcomes:
measure: Behaviour Rating Inventory of Executive Functions (BRIEF)
timeFrame: two years
Secondary outcomes:
measure: Adult ADHD self-report scale (ASRSv1.1), 18 items version
timeFrame: two years
measure: Beck Depression Inventory (BDI)
timeFrame: two years
measure: Beck Anxiety Inventory (BAI)
timeFrame: two years
measure: Weiss Functional Impairment Rating Scale, self-report (WIFRS)
timeFrame: two years
measure: Global Assessment of functioning (GAF)
timeFrame: two years
measure: Adult ADHD Quality of Life Scale (AAQoL)
timeFrame: two years
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: two years
measure: Safety issue - Monitoring of adverse events
timeFrame: two years
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Division of Mental Health and Addiction, Vestfold Hospital Trust
Study officials:
affiliation: Hospital of Oslo
name: Ellen K Munkhaugen, MSED
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Philipsen 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.
citation: Philipsen 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.
citation: Hirvikoski 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.
citation: Morgensterns 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.
citation: Hesslinger 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.