An interventional study of iCBT for Adults with ADHD and Internet stress-reduction in ADHD, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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
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.
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).
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's planned enrollment of 175 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
A skill training internet-based treatment program based on CBT and DBT interventions .
Behavioral: iCBT for Adults with ADHD
Internet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group)
Behavioral: Internet stress-reduction
Treatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24)
Other: Treatment as usual (TAU)/waiting list
A skill training internet-based treatment program based on CBT and DBT interventions .
Internet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group)
Treatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24)
Change (from baseline) in ASRS- v 1.1
ADHD Self Report Scale (ASRS) (self rating)
Time frame: Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in ADHD Rating Scale
ADHD Rating Scale - assessed by an expert rater blind to Group allocation
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in EQ-5D
Euroqol - (self report) to measure general health and quality of life
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in ISI
Insomnia Severity Index - (self report) to measure insomnia symptoms
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in PSS-4
Perceived Stress Scale - (self report) to measure level of stress in everyday life
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in SDS
Sheehan Disability Scale - (self report) to measure level of disability in everyday life
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in MADRS-S
Montgomery-Åsberg Depression Rating Scale - (self report) to measure level of depression
Time frame: Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in DERS
Difficulties of Emotion Regulation Scale - (self report)
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in AaQoL
Adult ADHD Quality of Life Measure - self report
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in SWLS
Satisfaction With Life Scale (self report) - measuring life quality. To evaluate the impact of the intervention on quality of Life, only the first three items in the scale will be used since the last two includes the whole Life-span and not just how Life quality is percived at the moment.
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in WAI-1
Work Ability Index (self report - one item) - a self estimation of working ability
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Changes (from baseline) in CGI-S
Clinical Global Impression - Severity scale - assessed by a blind expert rater - measuring symptom severity
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Treatment evaluation
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.
Time frame: during treatment and after 12 weeks of treatment (post)
CGI-I
Clinical Global Impression - Improvement scale (rated by a clinician in order to detect level of improvement or worsening due to treatment)
Time frame: 12 weeks (post) and after 3 and 12 months (post)
TCS
Treatment Credibility Scale (self report)
Time frame: Filled out by the patient at the 1st and 5th week of treatment
*CSQ-8
Client Satisfaction Questionnaire-8 (self report) - in order to evaluate the treatment satisfaction
Time frame: 12 weeks (post)
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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