Evaluation of the efficacy and effectiveness of a structured disorder tailored psychotherapy in ADHD in adults: study protocol of a randomized controlled multicentre trial

Abstract

ADHD is a serious risk factor for co-occurring psychiatric disorders and negative psychosocial consequences in adulthood. Previous trials on psychotherapeutic concepts for adult ADHD are based on behavioural (cognitive behavioural and dialectical behavioural) psychotherapeutic approaches and showed significant effects. The aim of our study group (COMPAS) is to carry out a first randomized and controlled multicentre study to evaluate the effects of a disorder tailored psychotherapy in adult ADHD compared to clinical management in combination with psychopharmacological treatment or placebo. A total of 448 adults with ADHD according to DSM-IV will be treated at seven university sites in Germany. In a four-arm design, patients are randomized to a manualized dialectical behavioural therapy (DBT) based group programme plus methylphenidate or placebo or clinical management plus methylphenidate or placebo with weekly sessions in the first 12 weeks and monthly sessions thereafter. Therapists are graduated psychologists or physicians. Treatment integrity is established by independent supervision. Primary endpoint (ADHD symptoms measured by the Conners Adult Rating Scale) is rated by interviewers blind to the treatment allocation. Intention-to-treat analysis will be performed within a linear regression model (Current Controlled Trials ISRCTN54096201). The trial is funded by the German Federal Ministry of Research and Education (01GV0606) and is part of the German network for the treatment of ADHD in children and adults (ADHD-NET).

Dysregulation between emotion and theory of mind networks in borderline personality disorder

“…In an attempt to explore the potential of the abovementioned dysconnectivity as a biological marker for BPD, it is recommended that future studies should also carry out functional connectivity analyses in the most commonly documented comorbidities of BPD, which are MDD, attention deficit hyperactivity disorder (ADHD), and PTSD. PTSD is of particular interest given that both BPD and PTSD are highly related to experiences of trauma (Zetzsche et al, 2006;Pagura et al, 2010;Philipsen et al, 2010;Stein et al, 2010), and many common neurobiological abnormalities have been identified between the two (O'Neill et al, 2013). Although MDD was the only comorbidity that was allowed in our BPD sample, which increased the homogeneity of the sample, this in itself may limit the generalisability of the findings given the high occurrence of other/additional comorbidities found in the wider population of individuals with BPD.…”

The effect of methylphenidate intake on brain structure in adults with ADHD in a placebo-controlled randomized trial

“…The study protocol and diagnostic procedure were implemented within the clinical COMPAS trial. 29,30 Appendix 1, Table S1, available at jpn.ca, lists the eligibility criteria for study partici pation. Appendix 1, Table S2 lists the applied diagnostic instruments.…”

“…Group psychotherapy or CM plus a medication number (coding for MPH or placebo) were centrally assigned to each patient. 29,30 Treatments were allocated with a 1:1:1:1 ratio, stratified by centre. 31 Patients and therapists were blinded for medication, but were aware of the assignment to either GPT or CM.…”

“…[23][24][25][26]28 This government-funded imaging study is part of a larger project comparing the effects of group psychotherapy (GPT) and clinical management (CM) and the effects of MPH and placebo in a factorial 2 × 2, double-blind, multicentre study (COMPAS trial; EudraCT Number: 2006-000222-31; Current Controlled Trials ISRCTN54096201; BMBF 01GV0606). 29,30 Following a baseline assessment (week 0) patients were randomized either to GPT + MPH, GPT + placebo, CM + MPH or CM + placebo. Group psychotherapy took place in weekly closed groups of 6-9 patients until week 13, followed by monthly sessions until week 52.…”

“…Participants randomized to CM received weekly (monthly after week 13) supportive counselling in individual sessions that lasted 15-20 min. 29,30 The results of the clinical trial are published elsewhere. 31 Neuro imaging measurements were obtained at baseline (week 0), after 3 months (week 13) and after 1 year (week 52).…”