Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults

NCT00278473 | Completed Results

• 3 other identifiers: GCO 03-1059R34MH071721DATR A2-AIR
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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).

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• 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.

  baseline and at 12 weeks

Secondary Outcomes (4)

• CAARS-O:L

  baseline and at 12 weeks

• Beck Depression Inventory

  baseline and at 12 weeks

• Hamilton Anxiety Rating Scale

  baseline and at 12 weeks

• Rosenberg Self-Esteem Inventory

  baseline and at 12 weeks

Study Arms (2)

Meta-Cognitive Therapy

EXPERIMENTAL

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.

Behavioral: Meta-Cognitive Therapy

Supportive Therapy

ACTIVE COMPARATOR

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.

Behavioral: Supportive Therapy

Interventions

Meta-Cognitive Therapy BEHAVIORAL

Cognitive Behavioral Group Treatment

Also known as: Cognitive Behavioral Group

Meta-Cognitive Therapy

Supportive Therapy BEHAVIORAL

Social Support Problem-Solving Group Treatment

Also known as: Social Support Problem-Solving Group

Supportive Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected of having or have been diagnosed with ADHD
• May potentially benefit from the ADHD group treatment

You may not qualify if:

• Any overt cognitive disability (e.g., Alzheimer's disease, mental retardation)
• Deemed not to potentially benefit from the proposed ADHD group treatment

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

participants were required to meet minimum levels of severity of symptoms and may select nonresponders or suboptimal responders to medication. Small sample may affects potential moderating and mediating variables

Results Point of Contact

• Title: Dr. Mary V. Solanto
• Organization: Icahn School of Medicine at Mount Sinai

Mary.Solanto@mssm.edu

212-241-5420

Study Officials

• Mary V. Solanto, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2006
• First Posted: January 18, 2006
• Study Start: May 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Locations

US (1)