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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326427
Recruitment Status : Completed
First Posted : October 31, 2017
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Skill Training Group of the Dialectical Behavior Therapy Other: Treatment as Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 7, 2018
Actual Primary Completion Date : November 24, 2018
Actual Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Skill Training Group
A twelve sessions protocol of the Skill Training Group of the Dialectical Behavior Therapy.
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.

Active Comparator: Treatment as Usual
Patients will have one psychiatric session to control their medication adherence.
Other: Treatment as Usual
Conventional protocol using only medication (including drug adherence).
Other Name: waiting list




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Change in Attention-Deficit/Hyperactive Disorder Self Rating Scale - Mid-treatment [ Time Frame: 6 Weeks ]
    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.

  2. Change in Attention-Deficit/Hyperactive Disorder Quality of Life [ Time Frame: 12 Weeks ]

    "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.


  3. Change in Attention-Deficit/Hyperactive Disorder Quality of Life - Mid-treatment [ Time Frame: 6 weeks ]

    "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.


  4. Change in Beck Depression Inventory [ Time Frame: 12 Weeks ]
    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.

  5. Change in Beck Depression Inventory - Mid-treatment [ Time Frame: 6 Weeks ]
    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. Change in Beck Anxiety Inventory [ Time Frame: 12 Weeks ]
    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.

  7. Change in Beck Anxiety Inventory - Mid-treatment [ Time Frame: 6 Weeks ]
    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.

  8. Change in the reflexive function questionnaire [ Time Frame: 12 weeks ]
    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.

  9. Change in the reflexive function questionnaire - Mid-treatment [ Time Frame: 6 weeks ]
    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.

  10. Change in the Go NoGo [ Time Frame: 14 weeks ]

    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.


  11. Change in Stroop Task [ Time Frame: 14 Weeks ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326427


Locations
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Brazil
Centro de Pesquisa Clínica
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Luis Augusto Rohde UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
Additional Information:
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03326427    
Other Study ID Numbers: 17-0358
65041316400005327 ( Other Identifier: CAAE )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Attention Deficit Hyperactive Disorder
Skill Training Group
Dialectical Behavior Therapy
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms