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Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meta-Cognitive Therapy
Supportive Therapy
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Primarily Inattentive, Hyperactive Impulsive Type, Combined Type, ADHD, Adults, Psychological, Cognitive Behavioral Therapy, CBT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Suspected of having or have been diagnosed with ADHD May potentially benefit from the ADHD group treatment Exclusion Criteria: Any overt cognitive disability (e.g., Alzheimer's disease, mental retardation) Deemed not to potentially benefit from the proposed ADHD group treatment

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Meta-Cognitive Therapy

Supportive Therapy

Arm Description

Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.

Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.

Outcomes

Primary Outcome Measures

Inattention Subscale
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Inattention subscale. Mean change score at 12 weeks as compared to baseline. Each item is scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe); the maximum total score with 27 points being the most severe.
Time Management, Organization, and Planning Subscale
Time management, organization, and planning subscale at posttreatment at 12 weeks as compared to baseline. The mean difference On Time Management Organization and Planning scale which is a 24-item self-report questionnaire that uses a 7-point Likert-type scale ranging from -3 (far below average) to +3 (far above average) and subsequently totaled to obtain a composite index of proficiency (possible scores range from -102 to +102), which was developed and previously used at the ADHD program at the Icahn School of Medicine at Mount Sinai.

Secondary Outcome Measures

CAARS-O:L
Change in the Conners Adult ADHD Rating Scales-Observer: Long Version (CAARS-O:L), inattention/memory subscale at 12 weeks as compared to baseline. 12 items subscale. T-score of at least 63 gives risk or possible diagnosis of ADHD. This number, lower or higher, does not indicate severity.
Beck Depression Inventory
Mean change in the Beck Depression Inventory Scale at 12 weeks as compared to baseline. The Beck Depression Inventory, 2nd edition to assess Depression symptoms. BDI-II scores range between 0 and 63, with categorical depression ratings of "minimal" (0-13), "mild" (14-19), "moderate" (20-28), and "severe" (29-63).
Hamilton Anxiety Rating Scale
Mean Change in Hamilton Anxiety Rating Scale at 12 weeks as compared to baseline. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Rosenberg Self-Esteem Inventory
Mean change in Rosenberg Self-Esteem Inventory score at 12 weeks as compared to baseline. The scale is a ten item Likert scale, ranging from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.

Full Information

First Posted
January 13, 2006
Last Updated
February 16, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00278473
Brief Title
Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults
Official Title
Treatment of Meta-Cognitive Deficits in Adults With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will determine the effectiveness of group cognitive-behavioral therapy as compared to a problem-solving social support group in treating problems of time management, organization, and planning in adults with attention deficit hyperactivity disorder (ADHD).
Detailed Description
ADHD is a chronic neurobiological condition that affects people of all ages, genders, and races. Symptoms of ADHD may include, but are not limited to, the following: poor attention span; physical restlessness or hyperactivity; excessive impulsivity; chronic procrastination; frequently losing things; poor organization, planning, and time management skills; and excessive forgetfulness. Not every person with ADHD exhibits all of these symptoms, and the severity of the disorder can range from mild to severe. While there is no cure for ADHD, the condition can be managed with an accurate diagnosis and proper treatment. Left untreated, individuals with ADHD may experience significant impairment in social, emotional, occupational, and academic functioning. Stimulant and non-stimulant medications are usually effective in alleviating symptoms of ADHD in adults. However, some research suggests that medications may not effectively treat self-management functioning problems and that as many as one-third of adults with ADHD have inadequate responses to medication treatment. Additional research on the benefits of psychosocial treatments for ADHD in adults is needed. This study will determine the effectiveness of group cognitive-behavioral therapy as compared to a problem-solving social support group in treating problems of time management, organization, and planning in adults with ADHD. Individuals interested in participating in this study will first undergo an assessment of their eligibility for inclusion in the study. The assessment will last approximately 6 hours, but can be broken up into as many as 4 separate visits. Eligible participants will be randomly assigned to either receive group cognitive-behavioral therapy or join a problem-solving social support group. Both groups will meet once a week for 12 weeks. Each session will last roughly 2 hours and will focus on building time management, organizational, and planning skills. Time management, planning, and organizational skill levels will be assessed at the treatment mid-point, immediately following the intervention, and at 3 and 6 months following the treatment. Self-esteem and symptoms of depression and anxiety will also be measured at these visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Primarily Inattentive, Hyperactive Impulsive Type, Combined Type, ADHD, Adults, Psychological, Cognitive Behavioral Therapy, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meta-Cognitive Therapy
Arm Type
Experimental
Arm Description
Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
Arm Title
Supportive Therapy
Arm Type
Active Comparator
Arm Description
Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
Intervention Type
Behavioral
Intervention Name(s)
Meta-Cognitive Therapy
Other Intervention Name(s)
Cognitive Behavioral Group
Intervention Description
Cognitive Behavioral Group Treatment
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy
Other Intervention Name(s)
Social Support Problem-Solving Group
Intervention Description
Social Support Problem-Solving Group Treatment
Primary Outcome Measure Information:
Title
Inattention Subscale
Description
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Inattention subscale. Mean change score at 12 weeks as compared to baseline. Each item is scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe); the maximum total score with 27 points being the most severe.
Time Frame
12 weeks
Title
Time Management, Organization, and Planning Subscale
Description
Time management, organization, and planning subscale at posttreatment at 12 weeks as compared to baseline. The mean difference On Time Management Organization and Planning scale which is a 24-item self-report questionnaire that uses a 7-point Likert-type scale ranging from -3 (far below average) to +3 (far above average) and subsequently totaled to obtain a composite index of proficiency (possible scores range from -102 to +102), which was developed and previously used at the ADHD program at the Icahn School of Medicine at Mount Sinai.
Time Frame
baseline and at 12 weeks
Secondary Outcome Measure Information:
Title
CAARS-O:L
Description
Change in the Conners Adult ADHD Rating Scales-Observer: Long Version (CAARS-O:L), inattention/memory subscale at 12 weeks as compared to baseline. 12 items subscale. T-score of at least 63 gives risk or possible diagnosis of ADHD. This number, lower or higher, does not indicate severity.
Time Frame
baseline and at 12 weeks
Title
Beck Depression Inventory
Description
Mean change in the Beck Depression Inventory Scale at 12 weeks as compared to baseline. The Beck Depression Inventory, 2nd edition to assess Depression symptoms. BDI-II scores range between 0 and 63, with categorical depression ratings of "minimal" (0-13), "mild" (14-19), "moderate" (20-28), and "severe" (29-63).
Time Frame
baseline and at 12 weeks
Title
Hamilton Anxiety Rating Scale
Description
Mean Change in Hamilton Anxiety Rating Scale at 12 weeks as compared to baseline. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time Frame
baseline and at 12 weeks
Title
Rosenberg Self-Esteem Inventory
Description
Mean change in Rosenberg Self-Esteem Inventory score at 12 weeks as compared to baseline. The scale is a ten item Likert scale, ranging from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Time Frame
baseline and at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected of having or have been diagnosed with ADHD May potentially benefit from the ADHD group treatment Exclusion Criteria: Any overt cognitive disability (e.g., Alzheimer's disease, mental retardation) Deemed not to potentially benefit from the proposed ADHD group treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary V. Solanto, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults

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