Trial Outcomes & Findings for Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults (NCT NCT00278473)

NCT ID: NCT00278473

Last Updated: 2017-04-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 88 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-04-04

Participant Flow

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	45	43
Overall Study COMPLETED	41	40
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	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.	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.
Overall Study drop out	4	3

Baseline Characteristics

Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults

Baseline characteristics by cohort

Measure	Meta-Cognitive Therapy n=45 Participants 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.	Supportive Therapy n=43 Participants 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.	Total n=88 Participants Total of all reporting groups
Age, Continuous	41.04 years STANDARD_DEVIATION 11.59 • n=5 Participants	42.37 years STANDARD_DEVIATION 12.09 • n=7 Participants	41.69 years STANDARD_DEVIATION 11.78 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Meta-Cognitive Therapy n=41 Participants 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.	Supportive Therapy n=40 Participants 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.
Inattention Subscale	-13.71 units on a scale Standard Deviation 4.27	-16.18 units on a scale Standard Deviation 4.71

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Meta-Cognitive Therapy n=41 Participants 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.	Supportive Therapy n=40 Participants 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.
Time Management, Organization, and Planning Subscale	-7.66 units on a scale Standard Deviation 2.83	-9.70 units on a scale Standard Deviation 3.16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meta-Cognitive Therapy n=41 Participants 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.	Supportive Therapy n=40 Participants 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.
CAARS-O:L	-66.94 T-score Standard Deviation 11.64	-73.19 T-score Standard Deviation 10.33

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Meta-Cognitive Therapy n=41 Participants 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.	Supportive Therapy n=40 Participants 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.
Beck Depression Inventory	-9.66 units on a scale Standard Deviation 8.31	-9.08 units on a scale Standard Deviation 7.16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meta-Cognitive Therapy n=41 Participants 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.	Supportive Therapy n=40 Participants 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.
Hamilton Anxiety Rating Scale	-8.07 units on a scale Standard Deviation 5.38	-8.88 units on a scale Standard Deviation 5.63

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meta-Cognitive Therapy n=41 Participants 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.	Supportive Therapy n=40 Participants 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.
Rosenberg Self-Esteem Inventory	-18.39 units on a scale Standard Deviation 6.02	-19.5 units on a scale Standard Deviation 5.86

Adverse Events

Meta-Cognitive Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Supportive Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mary V. Solanto

Icahn School of Medicine at Mount Sinai

Phone: 212-241-5420

Email: Mary.Solanto@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place