CBT Through Internet and Smartphones for Adults With ADHD - a Randomized Controlled Trial — Ad5  

ADHD Clinical Trial

Official title: Psychological Treatment Through Internet and Smartphones for Adults With Attention Deficit Hyperactive Disorder (ADHD) - a Randomized Controlled Trial

Status Completed

Clinical Trial Summary

The purpose of this study is to further evaluate the treatment for adults with ADHD used in our previous study (clinicaltrials.gov ID NCT01659164). It will now be converted to therapist supported, internet-delivered cognitive behavioral therapy (iCBT) with an additional smartphone application and evaluated through a randomized controlled trial during 12 weeks. The patients will be randomized to one of three conditions

• an active treatment group where the intervention is based on cognitive - and dialectical behavioral therapy (CBT and DBT) and the mobile app.

• an active ICBT-treatment based on psychoeducation, a CBT stress-reduction program and Applied Relaxation, and

• treatment as usual (TAU) / waiting list.

The main objective of the study is to evaluate if both of the treatment conditions will show better outcomes than TAU regarding decreased ADHD symptoms and increased functioning and life quality.

Another objective is to evaluate if the group receiving the active iCBT treatment (based on CBT and DBT) will show better outcomes in comparison to the control group regarding ADHD symptoms, overall functioning and life quality.

Clinical Trial Description

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.

Although literature regarding psychological treatment is relatively limited, 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. The main treatment focus is to enhance executive and organizational skills, improvement of consequence thinking and impulse control as well as emotion regulation skills. However, the range of trained psychologist in this field is rather limited. Using internet for delivering evidence-based psychological treatment can therefore be a innovative treatment alternative in order to make inaccessible treatment available to a large group of patients with ADHD.

The actual treatment project aims to evaluate if adults with ADHD can benefit from psychological treatment delivered through Internet. About 150-200 patients will be recruited through several outpatient clinics in Stockholm. They will be randomized to one of three conditions - active psychological treatment (based on CBT and DBT), an active alternative treatment where they undergo a psychoeducational support program (based on CBT) or to treatment as usual (TAU) / waiting list. The patients in the treatment conditions will have a personal contact via the internet with a psychologist within the 12 week treatment period. Assessments will be done before, during and after treatment, and after 3 and 12 months. The patients in the TAU condition will be offered iCBT treatment after they have filled out the post assessments (after 12 weeks and at 3rd month after treatment). ;

Related Conditions & MeSH terms

• ADHD

• NCT number: NCT02041884
• Study type: Interventional
• Source: Karolinska Institutet
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Completion date: February 2017