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

H

Hospital de Clinicas de Porto Alegre

Status

Completed

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Other: Treatment as Usual
Behavioral: Skill Training Group of the Dialectical Behavior Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03326427
65041316400005327 (Other Identifier)
17-0358

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • patients that change their medications or their psychiatric conditions in the exclusion criteria above after the beginning of the protocol will have their data censored, but included in the intention to treat analyses. These patients will keep the right to attend all the sessions in the protocol at their discretion.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

31 participants in 2 patient groups

Skill Training Group
Experimental group
Description:
A twelve sessions protocol of the Skill Training Group of the Dialectical Behavior Therapy.
Treatment:
Behavioral: Skill Training Group of the Dialectical Behavior Therapy
Treatment as Usual
Active Comparator group
Description:
Patients will have one psychiatric session to control their medication adherence.
Treatment:
Other: Treatment as Usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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