Psychological Treatment for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
The purpose of this uncontrolled pilot study is to develop and make an initial evaluation of a new treatment manual for treatment of ADHD in adults. The objectives in the treatment is to build relational skills, skills in organizing and structuring everyday life, handle difficult emotions and impulses etc. The treatment will be in a group format and it is hypothesized that the psychological intervention will result in reduced ADHD symptoms and to decreased experience of stress and depressive symptoms. The uncontrolled design does not allow for any causal inferences from the results, this pilot study is primarily to be seen as a preparation before a subsequent RCT.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Psychological Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) - Pilot Evaluation of a New Treatment Manual Based on CBT and DBT|
- Change (from baseline) in ASRS- v 1.1 [ Time Frame: 14 weeks (post) ] [ Designated as safety issue: No ]ADHD Self Report Scale (self rating)
- Change (from baseline) in ADHD Rating Scale [ Time Frame: 14 weeks (post) ] [ Designated as safety issue: No ]ADHD Rating Scale - assessed by a clinician
- Change (from baseline) in EQ-5D [ Time Frame: 14 weeks (post) ] [ Designated as safety issue: No ]Euroqol - (self report) to measure general health and quality of life
- Change (from baseline) in ISI [ Time Frame: 14 weeks (post) ] [ Designated as safety issue: No ]Insomnia Severity Index - (self report) to measure insomnia symptoms
- Change (from baseline) in PSS-4 [ Time Frame: 14 weeks (post) ] [ Designated as safety issue: No ]Perceived Stress Scale - (self report) to measure level of stress in everyday life
- Change (from baseline) in Sheehan Disability Scale [ Time Frame: 14 weeks (post) ] [ Designated as safety issue: No ]Sheehan Disability Scale - (self report) to measure level of disability in everyday life
- Change (from baseline) in MADRS-S [ Time Frame: 14 weeks (post) ] [ Designated as safety issue: No ]Montgomery-Åsberg Depression Rating Scale - (self report) to measure level of depression
- Change (from baseline) in DERS [ Time Frame: 14 weeks (post) ] [ Designated as safety issue: No ]Difficulties of Emotion Regulation Scale - (self report)
- Treatment evaluation [ Time Frame: 14 weeks (post) ] [ Designated as safety issue: No ]The investigators design own questions in order to evaluate how the participants have experienced the intervention regarding to knowledge, usage of the treatment methods and possible difficulties that they have experienced during treatment. Our aim is to use these evaluations to evolve and improve the quality of the treatment manual.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Group treatment (uncontrolled)
Psychological treatment in group for adults with ADHD (pilot) during 14 weeks with focus on decreasing disabilities due to the condition.
Behavioral: Group treatment for adults with ADHD
14 weeks of group treatment for adults with ADHD
Approximately one-third of children with ADHD continue to be fully symptomatic into adulthood and many of the remainders often retain some residual problems that require treatment. Thus ADHD is a prevalent and chronic disabling disorder. Drugs provide first line treatment for adults with ADHD but are not enough for everybody, while we still lack proper evidence for promising psychological treatment. In addition to core symptoms of ADHD including regulatory difficulties of attention, activity level and impulses, difficulties with emotional regulation are common.
Follow-up studies of adults with ADHD have shown that only a few patients were offered sufficient treatment and support after the neuropsychiatric assessment and testing. The majority of adults diagnosed with ADHD are offered pharmacological treatment (stimulant medication) as the sole treatment. However, stimulant medication is not effective for up to 20-50 percent of adults as they may not experience symptom reduction or they are unable to tolerate the medication.
Consequently, the possible benefits of identifying and treating individuals with ADHD are extensive. Treatment of ADHD is preferably multimodal, i.e. consisting of more than one intervention.
There has been limited research to date concerning psychosocial treatments for adult ADHD. Studies of cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT) show that structured short-term therapies are promising in reducing ADHD related symptoms and increasing life quality. Focus in the CBT treatment is to build skills, increasing and compensating for deficits in the executive functioning due to impairments of the frontal lobe. DBT combines change-oriented skills from CBT with acceptance-oriented skills and core mindfulness skills. DBT skills have been tried out and validated as a promising intervention package for adults with ADHD through the research of Steven Safren and Bernd Hesslinger.
The objective of the planned study is to evaluate a new manual for group treatment, with a combination of treatment methods from Safrens and Hesslingers evidence-based treatment manuals. The aim of the pilot project is to create a clinically effective combination of the different methods of treatment, with a high degree of understanding, acceptance, use and perceived usefulness of the patients undergoing treatment. Both qualitative and quantitative data about patients' perceptions and use of the different methods will be collected during and after treatment to increase knowledge of how treatments can be developed and combined in order to better match the needs of patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659164
|Contact: Viktor Kaldo, Ph.D.||+firstname.lastname@example.org|
|Contact: Nils Lindefors, MD, Ph.Demail@example.com|
|Internetpsykiatrienheten, Psykiatri Sydväst, SLSO||Recruiting|
|Contact: Viktor Kaldo, Ph.D. +46707373859 firstname.lastname@example.org|
|Principal Investigator: Viktor Kaldo, Ph.D.|
|Principal Investigator:||Viktor Kaldo, Ph.D.||Karolinska Institutet|