Attention Deficit Disorder With HyperactivityNCT04439422
Short Structured Psychological Intervention for Adults With ADHD - a Randomized Controlled Trial
A study testing Short ADHD Intervention and Self-help material with limited therapist support in people with Attention Deficit Disorder With Hyperactivity, run by Cereb AB at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the effects of a novel psychological intervention for adult ADHD through a randomized controlled trial. Participants will be randomized to receive either a face-to-face manualized short psychological intervention, SAINT, or corresponding self-help material with limited access… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Short ADHD Intervention and Self-help material with limited therapist support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 25 Aug 2020to Aug 2022
- 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 ADHD according to DSM-IV or DSM-5.
- Score of 17 or higher on the Adult ADHD Self Report Scale (ASRS v1.1), on any one of the two subscales.
- Not medically treated for ADHD symptoms throughout the study period, or medically treated with central stimulants or comparable substances since at least one month, with no significant changes in dosage and no anticipated significant changes in dosage.
- No change in any other medical treatment for psychiatric symptoms.
- Ability to participate in treatment during the study period.
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- Abstinence from illegal substance use for at least three months.
- Access to and ability to use Internet and mobile phone during the study period.
- Ability to understand Swedish in speech and writing, and ability to fill-out forms online.
Who cannot join
- Clinical diagnosis of substance use disorder within three months prior to screening. Earlier episodic use of illegal substances is not excluding.
- Co-existing psychiatric condition or disorder expected to render the participant unable to follow-through the study processes.
- IQ ≤85 according to a prior neuropsychological assessment.
- Suicidality assessed at the first assessment interview.
- Organic brain syndrome.
- Autism spectrum disorder (ASD) where function is deemed too low for the treatment to be carried out, defined as ASD level 2 and level 3 according to DSM-5 and/or ASD with accompanying intellectual impairment and/or accompanying language impairment.
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- Severe depression, defined as >34 on the MADRS-S or at a clinical assessment.
- Other current psychological treatment for ADHD or prior participation in treatment deemed to interfere with the study design.
- Limited or very limited self-rated recognition of problems regarding impulse control and/or emotional instability, in combination with low self-rated impairment, on a tailor-made measure.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects of a novel psychological intervention for adult ADHD through a randomized controlled trial. Participants will be randomized to receive either a face-to-face manualized short psychological intervention, SAINT, or corresponding self-help material with limited access to therapist support. The main objective is to evaluate whether SAINT will show better outcomes on measures of ADHD-related symptoms, everyday function, and quality-of-life measures, when compared to the self-help material, and if any possible differences in outcomes are related to better treatment adherence in SAINT.
Read the detailed description
ADHD is associated with deficiencies in short-term memory and executive function, negatively affecting patients' abilities to organize, schedule, multitask, follow through on instructions and finish jobs. This leads to uneven performance and possibly chronic underperformance in relation to actual intellectual resources. Psychiatric comorbidity is common for patients with ADHD, with 70-80% of adult patients meeting the criteria for at least one more clinical diagnosis. ADHD is also associated with sensation seeking and reckless behavior, including substance use and criminal activity.
Despite an increase in demand for assessment and treatment of ADHD among adults, access to evidence-based treatment is limited. In Sweden, most adult patients with ADHD are only offered pharmacological treatment. Pharmacological treatment, while in many cases effective, does not meet the demands of all patients, with 20-50% of patients not experiencing enough initial effect and/or excessive side-effects. Pharmacological treatment of ADHD also shows problems with long-term adherence, with approximately half of patients terminating treatment within the first two years, regardless of initial effect. Research on psychological treatment for adult ADHD is limited, though studies on behavioral treatment, including short-term therapies based on cognitive behavior therapy (CBT) and dialectic behavior therapy (DBT), have shown promising results.
This project, dubbed Short ADHD Intervention (SAINT), is based on previous research and pilot-studies of psychological treatments for adult ADHD. An existing treatment manual, based on CBT and DBT practices, will be fitted into a five-session, intensive face-to-face behavioral intervention, with a booster session at a one-month follow-up. The intervention will be compared to an equally long, active comparative control, consisting of self-help material and limited therapist support via Internet. Approximately 80 participants will be recruited at outpatient clinics in Stockholm. The participants will be randomized to receive either SAINT or the self-help material and limited therapist support.
- Being tested
- Short ADHD Intervention, Self-help material with limited therapist support
- Keywords
- ADHD, Attention Deficit, Psychological Intervention, CBT, DBT, Self-Help, Adherence, Short Intervention
- 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.
Short ADHD InterventionBehavioural
Also called SAINT
Short, intensive psychological intervention based on CBT and DBT practices
Self-help material with limited therapist supportOther
Self-help material from an evidence-based treatment manual for adult ADHD with access to limited therapist support via Internet (control group)
| Study group | Role | What they receive |
|---|---|---|
| SAINT | Experimental | Not described Receives: Behavioral: Short ADHD Intervention |
| Self-help material | Active comparator | Not described Receives: Other: Self-help material with limited therapist support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (from baseline) on The Adult ADHD Quality of Life Questionnaire (AAQoL)
Measured: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Secondary outcomes (8)
Change (from baseline) on ADHD Self-Report Scale (ASRS; Self-report)
Measured: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on the ADHD Rating Scale (ADHD RS; Assessed by an expert rater)
Measured: Baseline, 5 weeks (post treatment)
Change (from baseline) on Montgomery Åsberg Depression Rating Scale (MADRS-S; Self-report)
Measured: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Sheehan Disability Scale (SDS; Self-report)
Measured: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Difficulties in Emotion Regulation Scale (Brief Version; DERS-16; Self-report)
Measured: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Satisfaction With Life Scale (SWLS; Self-report)
Measured: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Perceived Stress Scale (PSS; Self-report)
Measured: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Clinical Global Impression - Severity Scale (CGI-S; Assessed by an expert rater)
Measured: Baseline, 5 weeks (post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start25 Aug 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cereb AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Berkeh Nasri, Cereb AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439422
- Sponsor's protocol ID
- SAINT
- Status last verified
- Oct 2020
- First submitted
- 17 Jun 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Structured Psychological Intervention for Adults With ADHD - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04439422
- Acronym / sponsor ID
- SAINT
- Keywords
- ADHD, Attention Deficit, Psychological Intervention, CBT, DBT, Self-Help, Adherence, Short Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cereb ABIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 19 Jun 2020 (actual)
- 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 evaluate the effects of a novel psychological intervention for adult ADHD through a randomized controlled trial. Participants will be randomized to receive either a face-to-face manualized short psychological intervention, SAINT, or corresponding self-help material with limited access to therapist support. The main objective is to evaluate whether SAINT will show better outcomes on measures of ADHD-related symptoms, everyday function, and quality-of-life measures, when compared to the self-help material, and if any possible differences in outcomes are related to better treatment adherence in SAINT.
Detailed description
ADHD is associated with deficiencies in short-term memory and executive function, negatively affecting patients' abilities to organize, schedule, multitask, follow through on instructions and finish jobs. This leads to uneven performance and possibly chronic underperformance in relation to actual intellectual resources. Psychiatric comorbidity is common for patients with ADHD, with 70-80% of adult patients meeting the criteria for at least one more clinical diagnosis. ADHD is also associated with sensation seeking and reckless behavior, including substance use and criminal activity.
Despite an increase in demand for assessment and treatment of ADHD among adults, access to evidence-based treatment is limited. In Sweden, most adult patients with ADHD are only offered pharmacological treatment. Pharmacological treatment, while in many cases effective, does not meet the demands of all patients, with 20-50% of patients not experiencing enough initial effect and/or excessive side-effects. Pharmacological treatment of ADHD also shows problems with long-term adherence, with approximately half of patients terminating treatment within the first two years, regardless of initial effect. Research on psychological treatment for adult ADHD is limited, though studies on behavioral treatment, including short-term therapies based on cognitive behavior therapy (CBT) and dialectic behavior therapy (DBT), have shown promising results.
This project, dubbed Short ADHD Intervention (SAINT), is based on previous research and pilot-studies of psychological treatments for adult ADHD. An existing treatment manual, based on CBT and DBT practices, will be fitted into a five-session, intensive face-to-face behavioral intervention, with a booster session at a one-month follow-up. The intervention will be compared to an equally long, active comparative control, consisting of self-help material and limited therapist support via Internet. Approximately 80 participants will be recruited at outpatient clinics in Stockholm. The participants will be randomized to receive either SAINT or the self-help material and limited therapist support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAINT | Experimental | Behavioral: Short ADHD Intervention |
| Self-help material | Active comparator | Other: Self-help material with limited therapist support |
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 ADHD according to DSM-IV or DSM-5.
- Score of 17 or higher on the Adult ADHD Self Report Scale (ASRS v1.1), on any one of the two subscales.
- Not medically treated for ADHD symptoms throughout the study period, or medically treated with central stimulants or comparable substances since at least one month, with no significant changes in dosage and no anticipated significant changes in dosage.
- No change in any other medical treatment for psychiatric symptoms.
Key exclusion criteria (9 listed)
- Clinical diagnosis of substance use disorder within three months prior to screening. Earlier episodic use of illegal substances is not excluding.
- Co-existing psychiatric condition or disorder expected to render the participant unable to follow-through the study processes.
- IQ ≤85 according to a prior neuropsychological assessment.
- Suicidality assessed at 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 |
|---|---|---|
| Short ADHD InterventionAlso: SAINTShort, intensive psychological intervention based on CBT and DBT practices | Behavioural | SAINT |
| Self-help material with limited therapist supportSelf-help material from an evidence-based treatment manual for adult ADHD with access to limited therapist support via Internet (control group) | Other | Self-help material |
Primary outcome
Change (from baseline) on The Adult ADHD Quality of Life Questionnaire (AAQoL)
Time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
8 secondary outcomes
Change (from baseline) on ADHD Self-Report Scale (ASRS; Self-report)
Time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on the ADHD Rating Scale (ADHD RS; Assessed by an expert rater)
Time frame: Baseline, 5 weeks (post treatment)
Change (from baseline) on Montgomery Åsberg Depression Rating Scale (MADRS-S; Self-report)
Time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Sheehan Disability Scale (SDS; Self-report)
Time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Difficulties in Emotion Regulation Scale (Brief Version; DERS-16; Self-report)
Time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Satisfaction With Life Scale (SWLS; Self-report)
Time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Perceived Stress Scale (PSS; Self-report)
Time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Clinical Global Impression - Severity Scale (CGI-S; Assessed by an expert rater)
Time frame: Baseline, 5 weeks (post treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short ADHD Intervention and Self-help material with limited therapist support in people with Attention Deficit Disorder With Hyperactivity, run by Cereb AB 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 9 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: status not confirmed, as of the sponsor's last update on 14 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berkeh Nasri, PhD (+46739328138, berkeh.nasri@cereb.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (from baseline) on The Adult ADHD Quality of Life Questionnaire (AAQoL) (time frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)). 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 14 Oct 2020.