Group Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Disorder

NCT03326427 | Completed

• 2 other identifiers: 17-035865041316400005327
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Attention-Deficit/Hyperactive Disorder (ADHD) in adults is associated with global impairments and deficits in quality of life. The ADHD functional impairments during adulthood usually persist even after adequate medication treatment. The Skill Training Group of the Dialectical Behavioral Therapy (DBT) is one of the group therapies that had been adapted for the specific treatment of ADHD patients. Our primary aim is to explore the feasibility of the approach in different culture and to evaluate the efficacy of the Skill Training Group as an add-on treatment for adults using ADHD medication. This is a Randomized Clinical Trial comparing the Skill Training Group added to stimulants to treatment as usual. 52 adults previously diagnosed with ADHD and treated with stimulants in our ADHD outpatient program will be enrolled. Only patients with residual symptoms will be included (ADHD-Self Report Scale - ASRS ≥ 20). The intervention comprises the standard 12 sessions therapy program. The groups will have between 8 and 12 patients each, and will be conducted by a trained DBT therapist with supervision from a senior DBT therapist. The primary outcome will be the ASRS scores. Secondary outcomes include scores in ADHD Quality of Life, Beck's Depression Inventory, Beck's Anxiety Inventory, and performance in a neuropsychological test (difference between pre and post-intervention) (Stop Signal Task). Adherence to the protocol will also be checked. The recruitment was initially scheduled for beginning in November.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactive Disorder; Skill Training Group; Dialectical Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Adult Attention-Deficit/Hyperactive Disorder Self Rating Scale

  Sefl rated scale to measure Attention Deficit Hyperactive Disorder Symptoms Symptoms. ASRS has 18 questions about ADHD symptoms. Each question is scored between 0 (never happen), and 4 (very frequently). The total score goes from 0 up to 72. Higher scores mean more symptoms and higher ADHD's impairments.

  12 Weeks

Secondary Outcomes (11)

• Change in Attention-Deficit/Hyperactive Disorder Self Rating Scale - Mid-treatment

  6 Weeks

• Change in Attention-Deficit/Hyperactive Disorder Quality of Life

  12 Weeks

• Change in Attention-Deficit/Hyperactive Disorder Quality of Life - Mid-treatment

  6 weeks

• Change in Beck Depression Inventory

  12 Weeks

• Change in Beck Depression Inventory - Mid-treatment

  6 Weeks

Study Arms (2)

Skill Training Group

EXPERIMENTAL

A twelve sessions protocol of the Skill Training Group of the Dialectical Behavior Therapy.

Behavioral: Skill Training Group of the Dialectical Behavior Therapy

Treatment as Usual

ACTIVE COMPARATOR

Patients will have one psychiatric session to control their medication adherence.

Other: Treatment as Usual

Interventions

Skill Training Group of the Dialectical Behavior Therapy BEHAVIORAL

A 12 session version of the Skill Training Group of the Dialectical Behavior Therapy, adapted for treatment of ADHD.

Skill Training Group

Treatment as Usual OTHER

Conventional protocol using only medication (including drug adherence).

Also known as: waiting list

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with ADHD
• Medicated with following drugs and minimum daily dosages:
• Methylphenidate ≥ 0.5 mg/kg Lisdexamfetamine ≥ 30mg Bupropion ≥ 150 mg Modafinil ≥ 200mg Imipramine ≥ 1mg/kg
• At least one month of stabilized dosage for any psychiatric medication.
• ADHD-Self Report Scale ≥ 20.
• Knowledge of oral and written communication in Portuguese
• IQ\>85 (intelligence quotient)

You may not qualify if:

• diagnoses of Borderline or Anti-social personality disorders.
• diagnoses of autism spectrum disorder
• current episode of major depression or suicide toughs
• current episodes of mania or hypomania
• recent episodes of drug abuse (last 6 months)
• diagnoses of drug dependence

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Centro de Pesquisa Clínica

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

• Moritz GR, Pizutti LT, Cancian ACM, Dillenburg MS, de Souza LAS, Lewgoy LB, Basso P, Andreola MMP, Bau CHD, Victor MM, Teche SP, Grevet EH, Philipsen A, Rohde LAP. Feasibility trial of the dialectical behavior therapy skills training group as add-on treatment for adults with attention-deficit/hyperactivity disorder. J Clin Psychol. 2021 Mar;77(3):516-524. doi: 10.1002/jclp.23049. Epub 2020 Sep 2.

  PMID: 32880953 DERIVED

Related Links

• The therapy protocol that will be used at the research

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics; Waiting Lists

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Luis Augusto Rohde

  UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 31, 2017
• Study Start: April 7, 2018
• Primary Completion: November 24, 2018
• Study Completion: March 27, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)