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Clinical Trials/NCT04588181
NCT04588181
Completed
N/A

Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program

Hospital Vall d'Hebron0 sites90 target enrollmentJuly 25, 2016
ConditionsADHD

Overview

Phase
N/A
Intervention
Not specified
Conditions
ADHD
Sponsor
Hospital Vall d'Hebron
Enrollment
90
Primary Endpoint
Change in the Clinical Global Impression - Severity (CGI-S)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that begins in childhood and can persist throughout adolescence and adulthood. ADHD affects persistently about 5% of children and adolescents and about 2.5% of adults worldwide. The cognitive behavioral therapy (CBT) has proven to be effective in significantly reducing ADHD-symptoms, maintaining the effects during follow-up.

The aim of this study is to develop and validate a psychological treatment program for adult ADHD-patients consisting of six sessions based on Cognitive Behavioural Therapy (CBT) and to study the effectiveness of the developed program in short and long term.

A total of 90 patients will be randomized to two treatment groups (1:1). One group will receive 12 sessions of CBT and the other group six sessions of brief CBT.

It is expected that the short-term effectiveness of a CBT psychological treatment program of six group sessions will be the same as the response to the CBT psychological treatment program of twelve group sessions in adult ADHD-patients with stable drug treatment.

Registry
clinicaltrials.gov
Start Date
July 25, 2016
End Date
May 16, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Vall d'Hebron
Responsible Party
Principal Investigator
Principal Investigator

Josep Antoni Ramos-Quiroga

Head of Psychiatry Department

Hospital Vall d'Hebron

Eligibility Criteria

Inclusion Criteria

  • patient with ADHD
  • ADHD rating scale\>=24
  • stable pharmacological treatment

Exclusion Criteria

  • Bipolar Dissorder, Schizophrenia, Psicotic Disorders, Substance Abuse Disorder, Personality Disorders
  • Suicidity Ideation
  • Serious Organic desease
  • Participate in other Psychological Treatment during the study

Outcomes

Primary Outcomes

Change in the Clinical Global Impression - Severity (CGI-S)

Time Frame: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.

Change in the ADHD-Rating Scale (ADHD-RS)

Time Frame: In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.

The ADHD-RS is a 18-items scale self-report version for assessing symptoms for ADHD DSM-IV. It consists of a subscale of inattention (IN, 9-items), another of hyperactivity/impulsivity (H / I, 9-items) and the total (TOT, 18-items). The interviewees are asked about the frequency of the symptoms over the past 6 months. Each item is scored from 0 to 3 points, and the highest scores indicates more severe symptomatology of ADHD.

Secondary Outcomes

  • To assess the Health status(at Baseline)
  • Change in the Beck Depression Inventory (BDI-II)(In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.)
  • Change in the Functioning Assessment Short Test (FAST)(In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.)
  • Change in the State-Trait Anxiety Inventory (STAI)(In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.)
  • Change in the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)(In the 6 sessions group: at 6 weeks, at 12 weeks and at 24 weeks.In 12 session group: at 12 weeks, at 24 weeks and at 36 weeks.)
  • To assess the severity of ADHD symptons(at Baseline)
  • To assess the ADHD symptons at childhood(at Baseline)

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