Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Keywords
Group Therapy, Structured Skills Training, Dialectic Behavioural Therapy
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.
Interventions
BEHAVIORALStructural 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.
OTHERTreatment as usual
Treatment as usual includes clinical management and/or medication, and or supportive counselling by physician or nurse
Sponsors
Haukeland University Hospital
Oslo University Hospital
The Hospital of Vestfold
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behaviour Rating Inventory of Executive Functions (BRIEF) | two years | Change in executive function impairments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI) | two years | Change in depressive symptoms |
| Beck Anxiety Inventory (BAI) | two years | Change in anxiety symptoms |
| Weiss Functional Impairment Rating Scale, self-report (WIFRS) | two years | Change in functional impairments |
| Adult ADHD self-report scale (ASRSv1.1), 18 items version | two years | Change in ADHD symptoms |
| Adult ADHD Quality of Life Scale (AAQoL) | two years | Change in quality of life |
| Difficulties in Emotion Regulation Scale (DERS) | two years | Change in emotional regulation |
| Safety issue - Monitoring of adverse events | two years | Monitoring of adverse events |
| Global Assessment of functioning (GAF) | two years | Change in global symptoms and functioning |
Countries
Norway
Outcome results
None listed