Clinical trial NCT03326427: Group Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Disorder
Official title: Randomized Clinical Trial With Adapted Skill Training Group From Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Using Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactive Disorder
Skill Training Group
Dialectical Behavior Therapy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Adult Attention-Deficit/Hyperactive Disorder Self Rating Scale
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in Attention-Deficit/Hyperactive Disorder Self Rating Scale - Mid-treatment
timeFrame: 6 Weeks
measure: Change in Attention-Deficit/Hyperactive Disorder Quality of Life
timeFrame: 12 Weeks
measure: Change in Attention-Deficit/Hyperactive Disorder Quality of Life - Mid-treatment
timeFrame: 6 weeks
measure: Change in Beck Depression Inventory
timeFrame: 12 Weeks
measure: Change in Beck Depression Inventory - Mid-treatment
timeFrame: 6 Weeks
measure: Change in Beck Anxiety Inventory
timeFrame: 12 Weeks
measure: Change in Beck Anxiety Inventory - Mid-treatment
timeFrame: 6 Weeks
measure: Change in the reflexive function questionnaire
timeFrame: 12 weeks
measure: Change in the reflexive function questionnaire - Mid-treatment
timeFrame: 6 weeks
measure: Change in the Go NoGo
timeFrame: 14 weeks
measure: Change in Stroop Task
timeFrame: 14 Weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa Clínica
state: Rio Grande Do Sul
Study officials:
affiliation: UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
name: Luis Augusto Rohde
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.