ADHDNCT04588181
Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program
A study testing cognitive behavioral therapy (CBT) in people with ADHD, run by Hospital Vall d'Hebron.
Trial summary
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that begins in childhood and can persist throughout adolescence and adulthood. ADHD affects persistently about 5% of children and adolescents and about 2.5% of adults worldwide. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ADHD
- What is being tested?
- cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2016to 16 May 2019
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient with ADHD
- ADHD rating scale>=24
- CGI> 3
- stable pharmacological treatment
Who cannot join
- IQ<85
- Bipolar Dissorder, Schizophrenia, Psicotic Disorders, Substance Abuse Disorder, Personality Disorders
- Suicidity Ideation
- Serious Organic desease
- Participate in other Psychological Treatment during the study
About this study
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that begins in childhood and can persist throughout adolescence and adulthood. ADHD affects persistently about 5% of children and adolescents and about 2.5% of adults worldwide. The cognitive behavioral therapy (CBT) has proven to be effective in significantly reducing ADHD-symptoms, maintaining the effects during follow-up.
The aim of this study is to develop and validate a psychological treatment program for adult ADHD-patients consisting of six sessions based on Cognitive Behavioural Therapy (CBT) and to study the effectiveness of the developed program in short and long term.
Read more
A total of 90 patients will be randomized to two treatment groups (1:1). One group will receive 12 sessions of CBT and the other group six sessions of brief CBT.
It is expected that the short-term effectiveness of a CBT psychological treatment program of six group sessions will be the same as the response to the CBT psychological treatment program of twelve group sessions in adult ADHD-patients with stable drug treatment.
- Conditions
- ADHD
- Being tested
- cognitive behavioral therapy (CBT)
- 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.
cognitive behavioral therapy (CBT)Behavioural
Cognitive behavioral therapy (CBT) is a psycho-social intervention that aims to improve mental health. CBT focuses on challenging and changing unhelpful cognitive distortions (e.g. thoughts, beliefs, and attitudes) and behaviors, improving emotional regulation, and the development of personal coping strategies that target solving current problems.
| Study group | Role | What they receive |
|---|---|---|
| CBT 6 sessions | Experimental | Not described Receives: Behavioral: cognitive behavioral therapy (CBT) |
| CBT 12 sessions | Active comparator | Not described Receives: Behavioral: cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ADHD-Rating Scale (ADHD-RS)
The ADHD-RS is a 18-items scale self-report version for assessing symptoms for ADHD DSM-IV. It consists of a subscale of inattention (IN, 9-items), another of hyperactivity/impulsivity (H / I, 9-items) and the total (TOT, 18-items). The interviewees are asked about the frequency of the symptoms over the past 6 months. Each item is scored from 0 to 3 points, and the highest scores indicates more severe symptomatology of ADHD.
Measured: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
Change in the Clinical Global Impression - Severity (CGI-S)
Measured: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
Secondary outcomes (8)
To assess the severity of ADHD symptons
Assessed by Connors' Adult ADHD Rating Scales Self-report form (CAARS-S:L)
Measured: at Baseline
To assess the severity of ADHD symptons
Assessed by Connors' Adult ADHD Rating Scales Observer form (CAARS-O-L)
Measured: at Baseline
To assess the ADHD symptons at childhood
Assessed by Wender UTAH Rating Scale (WURS). This is a scale used in the diagnosis of attention deficit hyperactivity disorder based on behaviour and feelings experienced during childhood.
The self-report questionnaire consists of 61-items, 25 of which are highly relevant items for ADHD (thus used in the scale for ADHD) and can help link childhood symptoms with patterns of behaviour in adulthood.
The scale is however limited by the capacity of the patient to recall memories from childhood.
Each of the questions in the retrospective scale has 4 answer choices, awarded points from 0 to 4:
- Not at all or slightly (0 points);
- Mildly (1 point);
- Moderately (2 points);
- Quite a bit (3 points);
- Very much (4 points).
The results range between 0 and 100 when the 25-item scale is used and a cut-off at 46 points was provided. This means that patients who score 46 or above are likely to be diagnosed with attention deficit hyperactivity disorder.
Measured: at Baseline
To assess the Health status
Assessed by SF-36. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Measured: at Baseline
Change in the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) consist of 36 items. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed. The lower the score the more disability. The higher the score the less disability
Measured: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
Change in the Functioning Assessment Short Test (FAST)
It comprises 24 items that assess impairment or disability in six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. It is a likert scale. Each item is scored from 0 to 4. The total scored range is from 0 to 96 with a higher score indicating more disability problems.
Measured: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
Change in the Beck Depression Inventory (BDI-II)
the BDI-II also contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:
0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression
Measured: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
Change in the State-Trait Anxiety Inventory (STAI)
This inventory is made up of 40 questions and they are rated on a 4-point scale. Low scores indicate a mild form of anxiety whereas median scores indicate a moderate form of anxiety and high scores indicate a severe form of anxiety.
Measured: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start25 Jul 2016
- Primary completion28 Mar 2019
- Study completion16 May 2019
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.
- 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Antoni Ramos-Quiroga, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588181
- Sponsor's protocol ID
- PR(AE)249/2016
- Status last verified
- Oct 2020
- First submitted
- 23 Sep 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program
- ClinicalTrials.gov ID
- NCT04588181
- Acronym / sponsor ID
- PR(AE)249/2016
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 19 Oct 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.
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that begins in childhood and can persist throughout adolescence and adulthood. ADHD affects persistently about 5% of children and adolescents and about 2.5% of adults worldwide. The cognitive behavioral therapy (CBT) has proven to be effective in significantly reducing ADHD-symptoms, maintaining the effects during follow-up.
The aim of this study is to develop and validate a psychological treatment program for adult ADHD-patients consisting of six sessions based on Cognitive Behavioural Therapy (CBT) and to study the effectiveness of the developed program in short and long term.
A total of 90 patients will be randomized to two treatment groups (1:1). One group will receive 12 sessions of CBT and the other group six sessions of brief CBT.
It is expected that the short-term effectiveness of a CBT psychological treatment program of six group sessions will be the same as the response to the CBT psychological treatment program of twelve group sessions in adult ADHD-patients with stable drug treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT 6 sessions | Experimental | Behavioral: cognitive behavioral therapy (CBT) |
| CBT 12 sessions | Active comparator | Behavioral: cognitive behavioral therapy (CBT) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patient with ADHD
- ADHD rating scale>=24
- CGI> 3
- stable pharmacological treatment
Key exclusion criteria (5 listed)
- IQ<85
- Bipolar Dissorder, Schizophrenia, Psicotic Disorders, Substance Abuse Disorder, Personality Disorders
- Suicidity Ideation
- Serious Organic desease
- Participate in other Psychological Treatment during the study
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 |
|---|---|---|
| cognitive behavioral therapy (CBT)Cognitive behavioral therapy (CBT) is a psycho-social intervention that aims to improve mental health. CBT focuses on challenging and changing unhelpful cognitive distortions (e.g. thoughts, beliefs, and attitudes) and behaviors, improving emotional regulation, and the development of personal coping strategies that target solving current problems. | Behavioural | CBT 12 sessions, CBT 6 sessions |
Primary outcome
Change in the ADHD-Rating Scale (ADHD-RS)
Time frame: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
The ADHD-RS is a 18-items scale self-report version for assessing symptoms for ADHD DSM-IV. It consists of a subscale of inattention (IN, 9-items), another of hyperactivity/impulsivity (H / I, 9-items) and the total (TOT, 18-items). The interviewees are asked about the frequency of the symptoms over the past 6 months. Each item is scored from 0 to 3 points, and the highest scores indicates more severe symptomatology of ADHD.
Change in the Clinical Global Impression - Severity (CGI-S)
Time frame: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
8 secondary outcomes
To assess the severity of ADHD symptons
Time frame: at Baseline
To assess the severity of ADHD symptons
Time frame: at Baseline
To assess the ADHD symptons at childhood
Time frame: at Baseline
To assess the Health status
Time frame: at Baseline
Change in the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
Change in the Functioning Assessment Short Test (FAST)
Time frame: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
Change in the Beck Depression Inventory (BDI-II)
Time frame: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
Change in the State-Trait Anxiety Inventory (STAI)
Time frame: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.
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 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy (CBT) in people with ADHD, run by Hospital Vall d'Hebron.
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 4 inclusion and 5 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 in the ADHD-Rating Scale (ADHD-RS) (time frame: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.). The study lists 2 primary outcomes in all. 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 19 Oct 2020.