ADHDAd5NCT02041884
CBT Through Internet and Smartphones for Adults With ADHD - a Randomized Controlled Trial
A study testing iCBT for Adults with ADHD, Internet stress-reduction and Treatment as usual (TAU)/waiting list in people with ADHD, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD
- What is being tested?
- iCBT for Adults with ADHD, Internet stress-reduction and Treatment as usual (TAU)/waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Swedish citizen
- Clinical diagnosis of AD/HD according to DSM-IV or DSM-5
- Age 18-65
- 17 or more on the Adult ADHD Self Report Scale (ASRS v1.1)
- Not medically treated for adhd symptoms, or medically treated with central stimulants or comparable substance since at least one month with no significant changes in dosage and where no change in medical treatment is anticipated during the study time frame for the participant. No change in any other medical treatment is anticipated during the study time frame for the participant.
- Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
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- The participant hasn´t used drugs the last 3 months
- Access to, and ability to use the Internet and mobile phone during the study time
- ability to understand Swedish in speech and writing
Who cannot join
- Diagnosed substance abuse according to DSM-IV or DSM-5 criteria within 3 months prior to screening. Earlier episodic substance abuse is not excluding
- Co-existing psychiatric condition that investigators believe will unable the participant to follow through the training protocol and take part in measures taken during the study time frame.
- IQ ≤85 according to a neuropsychological assessment
- Suicidality risk which is assessed during the first assessment interview.
- Organic brain syndrome
- Serious somatic condition which will unable the participant to participate (through the training protocol)or, is anticipated to have a negative impact on the treatment results
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- Autism spectrum disorder where the function level is deemed too low for the treatment to be carried out which is defined as moderate or severe problems scale (level 2 and 3) according to DSM-5
- Severe depression defined by >34 p on MADRS-S or by a clinician´s assessment
- Other current psychological treatment for AD/HD or previous participation in such a treatment that is deemed to interfere with the study design
- severe writing and reading disabilities
- dyslexia of such degree that it impedes participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Treatment Through Internet and Smartphones for Adults With Attention Deficit Hyperactive Disorder (ADHD) - a Randomized Controlled Trial
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.
Read more
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.
Read the detailed 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).
- Conditions
- ADHD
- Being tested
- iCBT for Adults with ADHD, Internet stress-reduction, Treatment as usual (TAU)/waiting list
- Keywords
- Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, Applied Relaxation, Stress-reduction, Smartphone application, ADHD, Randomized controlled trial, Psychological treatment, Efficacy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT for Adults with ADHDBehavioural
A skill training internet-based treatment program based on CBT and DBT interventions .
Internet stress-reductionBehavioural
Internet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group)
Treatment as usual (TAU)/waiting listOther
Treatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24)
| Study group | Role | What they receive |
|---|---|---|
| iCBT | Experimental | A skill training internet-based treatment program based on CBT and DBT interventions . Receives: Behavioral: iCBT for Adults with ADHD |
| Internet stress-reduction | Active comparator | Internet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group) Receives: Behavioral: Internet stress-reduction |
| Treatment as usual (TAU)/waiting list | Other | Treatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24) Receives: Other: Treatment as usual (TAU)/waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (from baseline) in ASRS- v 1.1
ADHD Self Report Scale (ASRS) (self rating)
Measured: 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)
Secondary outcomes (11)
Change (from baseline) in ADHD Rating Scale
ADHD Rating Scale - assessed by an expert rater blind to Group allocation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Viktor Kaldo, Karolinska Institutet
- Investigators
- Viktor Kaldo, PhD/Ass prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041884
- Sponsor's protocol ID
- 2014/333-31
- Acronym
- Ad5
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2014
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment Through Internet and Smartphones for Adults With Attention Deficit Hyperactive Disorder (ADHD) - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02041884
- Acronym / sponsor ID
- Ad5 / 2014/333-31
- Conditions
- ADHD
- Keywords
- Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, Applied Relaxation, Stress-reduction, Smartphone application, ADHD, Randomized controlled trial, Psychological treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iCBT | Experimental | Behavioral: iCBT for Adults with ADHDA skill training internet-based treatment program based on CBT and DBT interventions . |
| Internet stress-reduction | Active comparator | Behavioral: Internet stress-reductionInternet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group) |
| Treatment as usual (TAU)/waiting list | Other | Other: Treatment as usual (TAU)/waiting listTreatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Swedish citizen
- Clinical diagnosis of AD/HD according to DSM-IV or DSM-5
- Age 18-65
- 17 or more on the Adult ADHD Self Report Scale (ASRS v1.1)
- Not medically treated for adhd symptoms, or medically treated with central stimulants or comparable substance since at least one month with no significant changes in dosage and where no change in medical treatment is anticipated during the study time frame for the participant. No change in any other medical treatment is anticipated during the study time frame for the participant.
Key exclusion criteria (11 listed)
- Diagnosed substance abuse according to DSM-IV or DSM-5 criteria within 3 months prior to screening. Earlier episodic substance abuse is not excluding
- Co-existing psychiatric condition that investigators believe will unable the participant to follow through the training protocol and take part in measures taken during the study time frame.
- IQ ≤85 according to a neuropsychological assessment
- Suicidality risk which is assessed during the first assessment interview.
- Organic brain syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCBT for Adults with ADHDA skill training internet-based treatment program based on CBT and DBT interventions . | Behavioural | iCBT |
| Internet stress-reductionInternet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group) | Behavioural | Internet stress-reduction |
| Treatment as usual (TAU)/waiting listTreatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24) | Other | Treatment as usual (TAU)/waiting list |
Primary outcome
Change (from baseline) in ASRS- v 1.1
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)
ADHD Self Report Scale (ASRS) (self rating)
11 secondary outcomes
Change (from baseline) in ADHD Rating Scale
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in EQ-5D
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in ISI
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in PSS-4
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in SDS
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in MADRS-S
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
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in AaQoL
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in SWLS
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Change (from baseline) in WAI-1
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Changes (from baseline) in CGI-S
Time frame: Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Information about the studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Kaldo, PhD/Ass prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT for Adults with ADHD, Internet stress-reduction and Treatment as usual (TAU)/waiting list in people with ADHD, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (from baseline) in ASRS- v 1.1 (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.