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

NCT02685254 | Completed

• 1 other identifier: 2015/1523 A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Group Therapy; Structured Skills Training; Dialectic Behavioural Therapy

Outcome Measures

Primary Outcomes (1)

• Behaviour Rating Inventory of Executive Functions (BRIEF)

  Change in executive function impairments

  two years

Secondary Outcomes (8)

• Adult ADHD self-report scale (ASRSv1.1), 18 items version

  two years

• Beck Depression Inventory (BDI)

  two years

• Beck Anxiety Inventory (BAI)

  two years

• Weiss Functional Impairment Rating Scale, self-report (WIFRS)

  two years

• Global Assessment of functioning (GAF)

  two years

Study Arms (2)

Initial group therapy

EXPERIMENTAL

'Structural skills training group' - Start up with weekly structured skills training group for 14 weeks supplemented by homework training

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)

Other: Treatment as usual

Interventions

Structural skills training group BEHAVIORAL

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.

Also known as: Dialectic behavioural group therapy

Initial group therapy

Treatment as usual OTHER

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

Initial control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any psychotic disorder
• Recently suicidal behaviour
• Pervasive developmental disorder
• Intellectual disability
• Seizures or any neurological diseases causing mental handicap

Sponsors & Collaborators

• University of Oslo: lead
• Haukeland University Hospital: collaborator
• Oslo University Hospital: collaborator
• The Hospital of Vestfold: collaborator

Study Sites (1)

Division of Mental Health and Addiction, Vestfold Hospital Trust

Tønsberg, 3103, Norway

Location

Related Publications (7)

• 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.

  PMID: 18091195 BACKGROUND

• 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.

  PMID: 24132867 BACKGROUND

• 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.

  PMID: 26536057 BACKGROUND

• 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.

  PMID: 21295767 BACKGROUND

• 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.

  PMID: 26410823 BACKGROUND

• 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.

  PMID: 12242579 BACKGROUND

• Halmoy 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.

  PMID: 36443712 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ellen K Munkhaugen, MSED

  Hospital of Oslo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Attending Physician

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 18, 2016
• Study Start: February 1, 2016
• Primary Completion: April 30, 2018
• Study Completion: May 15, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)