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
About this trial
This is an interventional treatment trial for ADHD
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
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
NCT ID
NCT04588181
First Posted
September 23, 2020
Last Updated
October 8, 2020
Sponsor
Hospital Vall d'Hebron
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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