Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults

Treatment of Meta-Cognitive Deficits in Adults With ADHD

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00278473

Enrollment

Registered

2006-01-18

Start date

2005-05-31

Completion date

2008-10-31

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Primarily Inattentive, Hyperactive Impulsive Type, Combined Type, ADHD, Adults, Psychological, Cognitive Behavioral Therapy, CBT

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.

Interventions

BEHAVIORALMeta-Cognitive Therapy

Cognitive Behavioral Group Treatment

BEHAVIORALSupportive Therapy

Social Support Problem-Solving Group Treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Inattention Subscale	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.
Time Management, Organization, and Planning Subscale	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.

Secondary

Measure	Time frame	Description
CAARS-O:L	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.
Beck Depression Inventory	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).
Hamilton Anxiety Rating Scale	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.
Rosenberg Self-Esteem Inventory	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.

Countries

United States

Participant flow

Recruitment details

Prospective participants were referred from New York area medical and psychiatric clinics, ADHD advocacy and self-help groups, community psychiatrists and primary care physicians, university health services, and postings on clinical trials web sites.

Participants by arm

Arm	Count
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.	45
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.	43
Total	88

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	drop out	4	3

Baseline characteristics

Characteristic	Meta-Cognitive Therapy	Supportive Therapy	Total
Age, Continuous	41.04 years STANDARD_DEVIATION 11.59	42.37 years STANDARD_DEVIATION 12.09	41.69 years STANDARD_DEVIATION 11.78
Sex: Female, Male Female	32 Participants	26 Participants	58 Participants
Sex: Female, Male Male	13 Participants	17 Participants	30 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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 frame: 12 weeks

Arm	Measure	Value (MEAN)	Dispersion
Meta-Cognitive Therapy	Inattention Subscale	-13.71 units on a scale	Standard Deviation 4.27
Supportive Therapy	Inattention Subscale	-16.18 units on a scale	Standard Deviation 4.71

Primary

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.