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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCBT | Experimental | A skill training internet-based treatment program based on CBT and DBT interventions . |
|
| Internet stress-reduction | Active Comparator | Internet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group) |
|
| Treatment as usual (TAU)/waiting list | Other | Treatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCBT for Adults with ADHD | Behavioral | A skill training internet-based treatment program based on CBT and DBT interventions . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change (from baseline) in ASRS- v 1.1 | ADHD Self Report Scale (ASRS) (self rating) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change (from baseline) in ADHD Rating Scale | ADHD Rating Scale - assessed by an expert rater blind to Group allocation | Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12) |
| Change (from baseline) in EQ-5D |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during treatment and after 12 weeks of treatment (post) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viktor Kaldo, PhD/Ass prof | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internetpsykiatrienheten, Psykiatri Sydväst, SLSO | Stockholm | Sweden |
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| Label | URL |
|---|---|
| Information about the study | View source |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Internet stress-reduction | Behavioral | Internet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group) |
|
| Treatment as usual (TAU)/waiting list | Other | Treatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24) |
|
Euroqol - (self report) to measure general health and quality of life
| 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 | 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 | 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 | 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 | 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) | 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 | 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. | 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 | 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 | Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12) |
| CGI-I |
Clinical Global Impression - Improvement scale (rated by a clinician in order to detect level of improvement or worsening due to treatment) |
| 12 weeks (post) and after 3 and 12 months (post) |
| TCS | Treatment Credibility Scale (self report) | 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 | 12 weeks (post) |