Effects of Structured Skills Training Group in Treatment of ADHD in Adults

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Effects of Structured Skills Training Group in Treatment of ADHD in Adults: a Controlled Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685254
• Other study ID #: 2015/1523 A
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: May 15, 2018

Study information

• Verified date: May 2018
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 15, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

Behavioral:
• Structural skills training group
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.

Other:
• Treatment as usual
Treatment as usual includes clinical management and/or medication, and or supportive counselling by physician or nurse

Locations

Country	Name	City	State
Norway	Division of Mental Health and Addiction, Vestfold Hospital Trust	Tønsberg

Sponsors (4)

Lead Sponsor	Collaborator
University of Oslo	Haukeland University Hospital, Oslo University Hospital, The Hospital of Vestfold

Country where clinical trial is conducted

Norway, 

References & Publications (6)

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. — View Citation

Hirvikoski T, Waaler E, Alfredsson J, Pihlgren C, Holmström A, Johnson A, Rück J, Wiwe C, Bothén P, Nordström 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. — View 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. — View 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, Bürger 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. — View 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, Bürger 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. Erratum in: JAMA Psychiatry. 2016 Jan;73(1):90. — View Citation

Philipsen A, Richter H, Peters J, Alm B, Sobanski E, Colla M, Münzebrock 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behaviour Rating Inventory of Executive Functions (BRIEF)	Change in executive function impairments	two years
Secondary	Adult ADHD self-report scale (ASRSv1.1), 18 items version	Change in ADHD symptoms	two years
Secondary	Beck Depression Inventory (BDI)	Change in depressive symptoms	two years
Secondary	Beck Anxiety Inventory (BAI)	Change in anxiety symptoms	two years
Secondary	Weiss Functional Impairment Rating Scale, self-report (WIFRS)	Change in functional impairments	two years
Secondary	Global Assessment of functioning (GAF)	Change in global symptoms and functioning	two years
Secondary	Adult ADHD Quality of Life Scale (AAQoL)	Change in quality of life	two years
Secondary	Difficulties in Emotion Regulation Scale (DERS)	Change in emotional regulation	two years
Secondary	Safety issue - Monitoring of adverse events	Monitoring of adverse events	two years