Attention Deficit Hyperactivity DisorderNCT03326427
Group Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Disorder
A study testing Skill Training Group of the Dialectical Behavior Therapy and Treatment as Usual in people with Attention Deficit Hyperactivity Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Attention-Deficit/Hyperactive Disorder (ADHD) in adults is associated with global impairments and deficits in quality of life. The ADHD functional impairments during adulthood usually persist even after adequate medication treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Skill Training Group of the Dialectical Behavior Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Apr 2018to 27 Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with ADHD
- Medicated with following drugs and minimum daily dosages:
- Methylphenidate ≥ 0.5 mg/kg Lisdexamfetamine ≥ 30mg Bupropion ≥ 150 mg Modafinil ≥ 200mg Imipramine ≥ 1mg/kg
- At least one month of stabilized dosage for any psychiatric medication.
- ADHD-Self Report Scale ≥ 20.
- Knowledge of oral and written communication in Portuguese
- IQ>85 (intelligence quotient)
Who cannot join
- diagnoses of Borderline or Anti-social personality disorders.
- diagnoses of autism spectrum disorder
- current episode of major depression or suicide toughs
- current episodes of mania or hypomania
- recent episodes of drug abuse (last 6 months)
- diagnoses of drug dependence
- patients that change their medications or their psychiatric conditions in the exclusion criteria above after the beginning of the protocol will have their data censored, but included in the intention to treat analyses. These patients will keep the right to attend all the sessions in the protocol at their discretion.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa Clínica
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Randomized Clinical Trial With Adapted Skill Training Group From Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Using Medication
Attention-Deficit/Hyperactive Disorder (ADHD) in adults is associated with global impairments and deficits in quality of life. The ADHD functional impairments during adulthood usually persist even after adequate medication treatment. The Skill Training Group of the Dialectical Behavioral Therapy (DBT) is one of the group therapies that had been adapted for the specific treatment of ADHD patients. Our primary aim is to explore the feasibility of the approach in different culture and to evaluate the efficacy of the Skill Training Group as an add-on treatment for adults using ADHD medication. This is a Randomized Clinical Trial comparing the Skill Training Group added to stimulants to treatment as usual. 52 adults previously diagnosed with ADHD and treated with stimulants in our ADHD outpatient program will be enrolled. Only patients with residual symptoms will be included (ADHD-Self Report Scale - ASRS ≥ 20). The intervention comprises the standard 12 sessions therapy program. The groups will have between 8 and 12 patients each, and will be conducted by a trained DBT therapist with supervision from a senior DBT therapist. The primary outcome will be the ASRS scores. Secondary outcomes include scores in ADHD Quality of Life, Beck's Depression Inventory, Beck's Anxiety Inventory, and performance in a neuropsychological test (difference between pre and post-intervention) (Stop Signal Task). Adherence to the protocol will also be checked. The recruitment was initially scheduled for beginning in November.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Skill Training Group of the Dialectical Behavior Therapy, Treatment as Usual
- Keywords
- Attention Deficit Hyperactive Disorder, Skill Training Group, Dialectical Behavior Therapy
- 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.
Skill Training Group of the Dialectical Behavior TherapyBehavioural
A 12 session version of the Skill Training Group of the Dialectical Behavior Therapy, adapted for treatment of ADHD.
Treatment as UsualOther
Also called waiting list
Conventional protocol using only medication (including drug adherence).
| Study group | Role | What they receive |
|---|---|---|
| Skill Training Group | Experimental | A twelve sessions protocol of the Skill Training Group of the Dialectical Behavior Therapy. Receives: Behavioral: Skill Training Group of the Dialectical Behavior Therapy |
| Treatment as Usual | Active comparator | Patients will have one psychiatric session to control their medication adherence. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adult Attention-Deficit/Hyperactive Disorder Self Rating Scale
Sefl rated scale to measure Attention Deficit Hyperactive Disorder Symptoms Symptoms.
ASRS has 18 questions about ADHD symptoms. Each question is scored between 0 (never happen), and 4 (very frequently). The total score goes from 0 up to 72. Higher scores mean more symptoms and higher ADHD's impairments.
Measured: 12 Weeks
Secondary outcomes (11)
Change in Attention-Deficit/Hyperactive Disorder Self Rating Scale - Mid-treatment
Sefl rated scale to measure Attention Deficit Hyperactive Disorder Symptoms. ASRS has 18 questions about ADHD symptoms. Each question is scored between 0 (never happen), and 4 (very frequently). The total score goes from 0 up to 72. Higher scores mean more symptoms and higher ADHD's impairments.
Measured: 6 Weeks
Change in Attention-Deficit/Hyperactive Disorder Quality of Life
"Adult Attention-Deficit/Hyperactivity Disorder Quality-of-Life Scale (AAQoL)" is a Self-rated scale for quality of life in ADHD.
The scale has 29 questions ranging from 1 to 5. The AaQol focuses on four areas of patients quality of life: mental health, life goals, productivity, and relationships. The total scores go from 0 to 145. Higher scores mean the patient has a worse perception of his quality of life.
Measured: 12 Weeks
Change in Attention-Deficit/Hyperactive Disorder Quality of Life - Mid-treatment
"Adult Attention-Deficit/Hyperactivity Disorder Quality-of-Life Scale (AAQoL)" is a Self-rated scale for quality of life in ADHD.
The scale has 29 questions ranging from 1 to 5. The AaQol focuses on four areas of patients quality of life: mental health, life goals, productivity, and relationships. The total scores go from 0 to 145. Higher scores mean the patient has a worse perception of his quality of life.
Measured: 6 weeks
Change in Beck Depression Inventory
Beck Depression Inventory (BDI) is a Self-rated scale for depression. BDI has 21 questions ranging from 0-4, with the maximum score being 63. Higher scores mean higher depression levels. Scores between 0-13 are considered minimal depression, between 14 and 19 are considered mild depression, from 20 to 28 moderate depression, over 29 are considered severe depression.
Measured: 12 Weeks
Change in Beck Depression Inventory - Mid-treatment
Beck Depression Inventory (BDI) is a Self-rated scale for depression BDI has 21 questions ranging from 0-4, with the maximum score being 63. Higher scores mean higher depression levels. Scores between 0-13 are considered minimal depression, between 14 and 19 are considered mild depression, from 20 to 28 moderate depression, over 29 are considered severe depression.
Measured: 6 Weeks
Change in Beck Anxiety Inventory
Beck Anxiety Inventory is a Self-rated scale for anxiety. BAI has 21 questions ranging from 0-4, with the maximum score being 63. Higher scores mean higher anxiety levels. Scores between 0-9 are considered normal, between 10 and 18 are considered mild to moderate anxiety, from 19 to 29 moderate to severe anxiety, over 30 are considered severe anxiety.
Measured: 12 Weeks
Change in Beck Anxiety Inventory - Mid-treatment
Beck Anxiety Inventory is a Self-rated scale for anxiety. BAI has 21 questions ranging from 0-4, with the maximum score being 63. Higher scores mean higher anxiety levels. Scores between 0-9 are considered normal, between 10 and 18 are considered mild to moderate anxiety, from 19 to 29 moderate to severe anxiety, over 30 are considered severe anxiety.
Measured: 6 Weeks
Change in the reflexive function questionnaire
A self-reported scale to measure reflexive psychological functions. The questionnaire has 8 questions variating from one to seven. Total scores have ranged between 8 and 56. Better reflexive functions mean lowers scores on the scale.
Measured: 12 weeks
Change in the reflexive function questionnaire - Mid-treatment
A self-reported scale to measure reflexive psychological functions. The questionnaire has 8 questions variating from one to seven. Total scores have ranged between 8 and 56. Better reflexive functions mean lowers scores on the scale.
Measured: 6 weeks
Change in the Go NoGo
Computer-based psychometric task. Consists of three stimuli, one green arrow to left, one pointing to the right, and one arrow pointing to both sides. Subjects have to press correctly to right or left in the presence of the correspondent arrow or do not press any in the presence of the arrow to both sides. The task takes around 5 minutes.
The aim is to measure impulsivity through response times, commissions and errors.
Measured: 14 weeks
Change in Stroop Task
neuropsychological test to measure response inhibition (impulse control). The task has four stimuli, two green arrows, pointing to the right or left, and two red arrows, pointing to the right or left. When the green stimuli appear the subject must press the button to the correspondent side, in the appearance of the red stimuli the subject must press a button of the opposing side.
Measured: 14 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start7 Apr 2018
- Primary completion24 Nov 2018
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Augusto Rohde, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326427
- Sponsor's protocol ID
- 17-0358
- Other IDs
- 65041316400005327
- Status last verified
- Feb 2020
- First submitted
- 9 Oct 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient's individual data will be available only for the researchers and additional members of the research team, and for the patients it self.
Publications
Moritz GR, Pizutti LT, Cancian ACM, Dillenburg MS, de Souza LAS, Lewgoy LB, Basso P, Andreola MMP, Bau CHD, Victor MM, Teche SP, Grevet EH, Philipsen A, Rohde LAP. Feasibility trial of the dialectical behavior therapy skills training group as add-on treatment for adults with attention-deficit/hyperactivity disorder. J Clin Psychol. 2021 Mar;77(3):516-524. doi: 10.1002/jclp.23049. Epub 2020 Sep 2.
PubMed 32880953
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial With Adapted Skill Training Group From Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Using Medication
- ClinicalTrials.gov ID
- NCT03326427
- Acronym / sponsor ID
- 17-0358
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactive Disorder, Skill Training Group, Dialectical Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 7 Apr 2018 (actual)
- Primary completion
- 24 Nov 2018 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 31 Oct 2017 (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/Hyperactive Disorder (ADHD) in adults is associated with global impairments and deficits in quality of life. The ADHD functional impairments during adulthood usually persist even after adequate medication treatment. The Skill Training Group of the Dialectical Behavioral Therapy (DBT) is one of the group therapies that had been adapted for the specific treatment of ADHD patients. Our primary aim is to explore the feasibility of the approach in different culture and to evaluate the efficacy of the Skill Training Group as an add-on treatment for adults using ADHD medication. This is a Randomized Clinical Trial comparing the Skill Training Group added to stimulants to treatment as usual. 52 adults previously diagnosed with ADHD and treated with stimulants in our ADHD outpatient program will be enrolled. Only patients with residual symptoms will be included (ADHD-Self Report Scale - ASRS ≥ 20). The intervention comprises the standard 12 sessions therapy program. The groups will have between 8 and 12 patients each, and will be conducted by a trained DBT therapist with supervision from a senior DBT therapist. The primary outcome will be the ASRS scores. Secondary outcomes include scores in ADHD Quality of Life, Beck's Depression Inventory, Beck's Anxiety Inventory, and performance in a neuropsychological test (difference between pre and post-intervention) (Stop Signal Task). Adherence to the protocol will also be checked. The recruitment was initially scheduled for beginning in November.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skill Training Group | Experimental | Behavioral: Skill Training Group of the Dialectical Behavior TherapyA twelve sessions protocol of the Skill Training Group of the Dialectical Behavior Therapy. |
| Treatment as Usual | Active comparator | Other: Treatment as UsualPatients will have one psychiatric session to control their medication adherence. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with ADHD
- Medicated with following drugs and minimum daily dosages:
- Methylphenidate ≥ 0.5 mg/kg Lisdexamfetamine ≥ 30mg Bupropion ≥ 150 mg Modafinil ≥ 200mg Imipramine ≥ 1mg/kg
- At least one month of stabilized dosage for any psychiatric medication.
- ADHD-Self Report Scale ≥ 20.
Key exclusion criteria (7 listed)
- diagnoses of Borderline or Anti-social personality disorders.
- diagnoses of autism spectrum disorder
- current episode of major depression or suicide toughs
- current episodes of mania or hypomania
- recent episodes of drug abuse (last 6 months)
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 |
|---|---|---|
| Skill Training Group of the Dialectical Behavior TherapyA 12 session version of the Skill Training Group of the Dialectical Behavior Therapy, adapted for treatment of ADHD. | Behavioural | Skill Training Group |
| Treatment as UsualAlso: waiting listConventional protocol using only medication (including drug adherence). | Other | Treatment as Usual |
Primary outcome
Change in Adult Attention-Deficit/Hyperactive Disorder Self Rating Scale
Time frame: 12 Weeks
Sefl rated scale to measure Attention Deficit Hyperactive Disorder Symptoms Symptoms. ASRS has 18 questions about ADHD symptoms. Each question is scored between 0 (never happen), and 4 (very frequently). The total score goes from 0 up to 72. Higher scores mean more symptoms and higher ADHD's impairments.
11 secondary outcomes
Change in Attention-Deficit/Hyperactive Disorder Self Rating Scale - Mid-treatment
Time frame: 6 Weeks
Change in Attention-Deficit/Hyperactive Disorder Quality of Life
Time frame: 12 Weeks
Change in Attention-Deficit/Hyperactive Disorder Quality of Life - Mid-treatment
Time frame: 6 weeks
Change in Beck Depression Inventory
Time frame: 12 Weeks
Change in Beck Depression Inventory - Mid-treatment
Time frame: 6 Weeks
Change in Beck Anxiety Inventory
Time frame: 12 Weeks
Change in Beck Anxiety Inventory - Mid-treatment
Time frame: 6 Weeks
Change in the reflexive function questionnaire
Time frame: 12 weeks
Change in the reflexive function questionnaire - Mid-treatment
Time frame: 6 weeks
Change in the Go NoGo
Time frame: 14 weeks
Change in Stroop Task
Time frame: 14 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 17 Feb 2020.
- Derived from this study: PubMed 32880953Moritz GR, Pizutti LT, Cancian ACM, Dillenburg MS, de Souza LAS, Lewgoy LB, Basso P, Andreola MMP, Bau CHD, Victor MM, Teche SP, Grevet EH, Philipsen A, Rohde LAP. Feasibility trial of the dialectical behavior therapy skills training group as add-on treatment for adults with attention-deficit/hyperactivity disorder. J Clin Psychol. 2021 Mar;77(3):516-524. doi: 10.1002/jclp.23049. Epub 2020 Sep 2.
- The therapy protocol that will be used at the researchLink provided by the sponsor.
- Individual participant dataSharing planned: No. Patient's individual data will be available only for the researchers and additional members of the research team, and for the patients it self.
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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.
Luis Augusto Rohde principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skill Training Group of the Dialectical Behavior Therapy and Treatment as Usual in people with Attention Deficit Hyperactivity Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 7 inclusion and 7 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 17 Feb 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 Brazil. 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 in Adult Attention-Deficit/Hyperactive Disorder Self Rating Scale (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326427, which also lists 1 linked publication.
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 17 Feb 2020.