Group Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Disorder
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Skill Training Group of the Dialectical Behavior Therapy
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactive Disorder, Skill Training Group, Dialectical Behavior Therapy
Eligibility Criteria
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.
Sites / Locations
- Centro de Pesquisa Clínica
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Skill Training Group
Treatment as Usual
Arm Description
A twelve sessions protocol of the Skill Training Group of the Dialectical Behavior Therapy.
Patients will have one psychiatric session to control their medication adherence.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03326427
First Posted
October 9, 2017
Last Updated
February 14, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03326427
Brief Title
Group Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 7, 2018 (Actual)
Primary Completion Date
November 24, 2018 (Actual)
Study Completion Date
March 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactive Disorder, Skill Training Group, Dialectical Behavior Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skill Training Group
Arm Type
Experimental
Arm Description
A twelve sessions protocol of the Skill Training Group of the Dialectical Behavior Therapy.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Patients will have one psychiatric session to control their medication adherence.
Intervention Type
Behavioral
Intervention Name(s)
Skill Training Group of the Dialectical Behavior Therapy
Intervention Description
A 12 session version of the Skill Training Group of the Dialectical Behavior Therapy, adapted for treatment of ADHD.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
waiting list
Intervention Description
Conventional protocol using only medication (including drug adherence).
Primary Outcome Measure Information:
Title
Change in Adult Attention-Deficit/Hyperactive Disorder Self Rating Scale
Description
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.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change in Attention-Deficit/Hyperactive Disorder Self Rating Scale - Mid-treatment
Description
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.
Time Frame
6 Weeks
Title
Change in Attention-Deficit/Hyperactive Disorder Quality of Life
Description
"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.
Time Frame
12 Weeks
Title
Change in Attention-Deficit/Hyperactive Disorder Quality of Life - Mid-treatment
Description
"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.
Time Frame
6 weeks
Title
Change in Beck Depression Inventory
Description
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.
Time Frame
12 Weeks
Title
Change in Beck Depression Inventory - Mid-treatment
Description
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.
Time Frame
6 Weeks
Title
Change in Beck Anxiety Inventory
Description
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.
Time Frame
12 Weeks
Title
Change in Beck Anxiety Inventory - Mid-treatment
Description
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.
Time Frame
6 Weeks
Title
Change in the reflexive function questionnaire
Description
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.
Time Frame
12 weeks
Title
Change in the reflexive function questionnaire - Mid-treatment
Description
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.
Time Frame
6 weeks
Title
Change in the Go NoGo
Description
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.
Time Frame
14 weeks
Title
Change in Stroop Task
Description
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.
Time Frame
14 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Augusto Rohde
Organizational Affiliation
UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisa Clínica
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patient's individual data will be available only for the researchers and additional members of the research team, and for the patients it self.
Citations:
PubMed Identifier
32880953
Citation
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/26536057
Description
The therapy protocol that will be used at the research
Learn more about this trial
Group Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Disorder
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