Group Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326427
• Other study ID #: 17-0358
• Secondary ID: 6504131640000532
• Status: Completed
• Phase: N/A
• Start date: April 7, 2018
• Est. completion date: March 27, 2019

Study information

• Verified date: February 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 27, 2019
• Est. primary completion date: November 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• Skill Training Group of the Dialectical Behavior Therapy
A 12 session version of the Skill Training Group of the Dialectical Behavior Therapy, adapted for treatment of ADHD.

Other:
• Treatment as Usual
Conventional protocol using only medication (including drug adherence).

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Clínica	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Weeks
Secondary	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.	6 Weeks
Secondary	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.	12 Weeks
Secondary	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.	6 weeks
Secondary	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.	12 Weeks
Secondary	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.	6 Weeks
Secondary	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.	12 Weeks
Secondary	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.	6 Weeks
Secondary	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.	12 weeks
Secondary	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.	6 weeks
Secondary	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.	14 weeks
Secondary	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.	14 Weeks

External Links

•   The therapy protocol that will be used at the research