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Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program

Primary Purpose

ADHD

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive behavioral therapy (CBT)
Sponsored by
Hospital Vall d'Hebron
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient with ADHD
  • ADHD rating scale>=24
  • CGI> 3
  • stable pharmacological treatment

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CBT 6 sessions

    CBT 12 sessions

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    Change in the Clinical Global Impression - Severity (CGI-S)

    Secondary Outcome Measures

    To assess the severity of ADHD symptons
    Assessed by Connors' Adult ADHD Rating Scales Self-report form (CAARS-S:L)
    To assess the severity of ADHD symptons
    Assessed by Connors' Adult ADHD Rating Scales Observer form (CAARS-O-L)
    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.
    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
    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
    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.
    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
    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.

    Full Information

    First Posted
    September 23, 2020
    Last Updated
    October 8, 2020
    Sponsor
    Hospital Vall d'Hebron
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04588181
    Brief Title
    Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program
    Official Title
    Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 25, 2016 (Actual)
    Primary Completion Date
    March 28, 2019 (Actual)
    Study Completion Date
    May 16, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Vall d'Hebron

    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/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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ADHD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CBT 6 sessions
    Arm Type
    Experimental
    Arm Title
    CBT 12 sessions
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    cognitive behavioral therapy (CBT)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in the ADHD-Rating Scale (ADHD-RS)
    Description
    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.
    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.
    Title
    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.
    Secondary Outcome Measure Information:
    Title
    To assess the severity of ADHD symptons
    Description
    Assessed by Connors' Adult ADHD Rating Scales Self-report form (CAARS-S:L)
    Time Frame
    at Baseline
    Title
    To assess the severity of ADHD symptons
    Description
    Assessed by Connors' Adult ADHD Rating Scales Observer form (CAARS-O-L)
    Time Frame
    at Baseline
    Title
    To assess the ADHD symptons at childhood
    Description
    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.
    Time Frame
    at Baseline
    Title
    To assess the Health status
    Description
    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
    Time Frame
    at Baseline
    Title
    Change in the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
    Description
    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
    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.
    Title
    Change in the Functioning Assessment Short Test (FAST)
    Description
    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.
    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.
    Title
    Change in the Beck Depression Inventory (BDI-II)
    Description
    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
    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.
    Title
    Change in the State-Trait Anxiety Inventory (STAI)
    Description
    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.
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient with ADHD ADHD rating scale>=24 CGI> 3 stable pharmacological treatment Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program

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