Short Structured Psychological Intervention for Adults With ADHD - a Randomized Controlled Trial

October 11, 2020 updated by: Berkeh Nasri, Cereb AB
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Cereb AB
        • Contact:
          • Berkeh Nasri, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAINT
Behavioral: Short ADHD Intervention
Short, intensive psychological intervention based on CBT and DBT practices
Other Names:
  • SAINT
Active Comparator: Self-help material
Other: Self-help material with limited therapist support
Self-help material from an evidence-based treatment manual for adult ADHD with access to limited therapist support via Internet (control group)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change (from baseline) on ADHD Self-Report Scale (ASRS; Self-report)
Time Frame: Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
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)
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)
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)
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)
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)
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)
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)
Baseline, 5 weeks (post treatment)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Global Impression - Improvement Scale (CGI-I; Assessed by an expert rater)
Time Frame: 5 weeks (post treatment)
5 weeks (post treatment)
Client Satisfaction Questionnaire (CSQ-8; Self-report)
Time Frame: 5 weeks (post treatment)
5 weeks (post treatment)
Treatment Credibility Scale (TCS; Self-report)
Time Frame: 1 week, 3 weeks
1 week, 3 weeks
Treatment Evaluation (Self-report)
Time Frame: 5 weeks (post treatment)
A tailor-made formulary to evaluate the participants' experience of the interventions, including any possible difficulties.
5 weeks (post treatment)
Adherence to Treatment (Self-report)
Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)
Using a tailor-made formulary.
1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)
Session Attendance (Assessed by an expert rater)
Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment), 9 weeks (FU1)
SAINT arm only.
1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment), 9 weeks (FU1)
Adverse Events During Treatment (Self-report)
Time Frame: 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Using a tailor-made formulary.
5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Changes in Other Treatment(s) During the Study Period (Self-report)
Time Frame: 5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)
Using a tailor-made formulary.
5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cereb AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAINT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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