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

Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Germany.
ADHD Attention Deficit and Hyperactivity Disorders 12/2010; 2(4):203-12. DOI: 10.1007/s12402-010-0046-7
Source: PubMed


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).

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Available from: Ludger Tebartz van Elst, Jun 16, 2014
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    • "There are now four manuals for psychological treatment of adults with ADHD, which enable replication and use of these interventions by clinicians [16-19]. The last year has seen the publication of three randomized controlled trials of CBT that are methodologically rigorous in diagnosis, use of objective outcomes, blinded raters and comparison with a non-specific form of treatment [17,20,21]. Solanto did not find that stratification by medication status changed her findings [21]. "
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    ABSTRACT: Previous studies of psychological treatment in adults with ADHD have not controlled for medication status and include either medicated participants or mixed samples of medicated and unmedicated participants. The objective of this study is to examine whether use of medication improves outcome of therapy. This was a secondary analysis comparing 23 participants randomized to CBT and Dextroamphetamine vs. 25 participants randomized to CBT and placebo. Both patients and investigators were blind to treatment assignment. Two co-primary outcomes were used: ADHD symptoms on the ADHD-RS-Inv completed by the investigator and improvement in functioning as reported by the patient on the Sheehan Disability Scale. Both groups showed robust improvement in both symptoms and functioning, but the use of medication did not significantly improve outcome over and above use of CBT and placebo. This study replicates previous work demonstrating that CBT is an effective treatment for ADHD in adults. Within the limits of this pilot, secondary analysis we were not able to demonstrate that medication significantly augments the outcome of CBT therapy for adults with ADHD. The study was funded by GlaxoSmithKline, Clinical Trials Registry #GSK707.
    Full-text · Article · Apr 2012 · BMC Psychiatry
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    ABSTRACT: The German version of the Conners Adult ADHD Rating Scales (CAARS) has proven to show very high model fit in confirmative factor analyses with the established factors inattention/memory problems, hyperactivity/restlessness, impulsivity/emotional lability, and problems with self-concept in both large healthy control and ADHD patient samples. This study now presents data on the psychometric properties of the German CAARS-self-report (CAARS-S) and observer-report (CAARS-O) questionnaires. CAARS-S/O and questions on sociodemographic variables were filled out by 466 patients with ADHD, 847 healthy control subjects that already participated in two prior studies, and a total of 896 observer data sets were available. Cronbach's-alpha was calculated to obtain internal reliability coefficients. Pearson correlations were performed to assess test-retest reliability, and concurrent, criterion, and discriminant validity. Receiver Operating Characteristics (ROC-analyses) were used to establish sensitivity and specificity for all subscales. Coefficient alphas ranged from .74 to .95, and test-retest reliability from .85 to .92 for the CAARS-S, and from .65 to .85 for the CAARS-O. All CAARS subscales, except problems with self-concept correlated significantly with the Barrett Impulsiveness Scale (BIS), but not with the Wender Utah Rating Scale (WURS). Criterion validity was established with ADHD subtype and diagnosis based on DSM-IV criteria. Sensitivity and specificity were high for all four subscales. The reported results confirm our previous study and show that the German CAARS-S/O do indeed represent a reliable and cross-culturally valid measure of current ADHD symptoms in adults.
    Full-text · Article · Mar 2011 · European Psychiatry

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