- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00278473
Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults
Treatment of Meta-Cognitive Deficits in Adults With ADHD
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Meta-Cognitive Therapy
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.
|
Cognitive Behavioral Group Treatment
Other Names:
|
Active Comparator: Supportive Therapy
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.
|
Social Support Problem-Solving Group Treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inattention Subscale
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Time Management, Organization, and Planning Subscale
Time Frame: baseline and at 12 weeks
|
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. |
baseline and at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAARS-O:L
Time Frame: baseline and at 12 weeks
|
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.
|
baseline and at 12 weeks
|
Beck Depression Inventory
Time Frame: baseline and at 12 weeks
|
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). |
baseline and at 12 weeks
|
Hamilton Anxiety Rating Scale
Time Frame: baseline and at 12 weeks
|
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.
|
baseline and at 12 weeks
|
Rosenberg Self-Esteem Inventory
Time Frame: baseline and at 12 weeks
|
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.
|
baseline and at 12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mary V. Solanto, PhD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 03-1059
- DATR A2-AIR
- R34MH071721 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit Disorder With Hyperactivity
-
Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
-
Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Karolinska InstitutetCompletedAttention Deficit Disorder With Hyperactivity (ADHD)Sweden
-
Rabin Medical CenterNG Solutions LtdRecruitingADHD - Attention Deficit Disorder With HyperactivityIsrael
-
Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
-
Clinical and Translational Genome Research Institute...Children's Specialized HospitalTerminatedAttention Deficit Disorders With HyperactivityUnited States
-
University of PennsylvaniaCompletedAttention Deficit Disorder With Hyperactivity (ADHD)United States
-
Nemours Children's ClinicCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
-
Massachusetts General HospitalRecruitingAttention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
-
New River PharmaceuticalsShireCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersUnited States
Clinical Trials on Meta-Cognitive Therapy
-
Norwegian University of Science and TechnologyPenn State University; University of ManchesterCompletedComparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GADGeneralized Anxiety DisorderNorway
-
Norwegian University of Science and TechnologyWithdrawnSecondary Insomnia
-
Fundació Sant Joan de DéuParc Sanitari Sant Joan de Déu; Corporacion Parc Tauli; Fundació Institut de... and other collaboratorsCompleted
-
Tel Aviv UniversityCompletedHuman Risk Factors | Driving Behavior | Meta-cognition
-
University of Western SydneyNational University of MalaysiaCompletedAutism Spectrum DisorderMalaysia
-
Institut Pasteur de LilleCompleted
-
University of WashingtonUnited States Department of DefenseRecruiting
-
Henry M. Jackson Foundation for the Advancement...Johns Hopkins UniversityRecruitingInjuries to the Hand and WristUnited States
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruiting
-
Henry M. Jackson Foundation for the Advancement...National Alliance for Research on Schizophrenia and DepressionCompletedSuicide, AttemptedUnited States