Clinical trial NCT04588181: Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program
Official title: Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Hospital Vall d'Hebron
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* patient with ADHD
* ADHD rating scale\>=24
* CGI\> 3
* stable pharmacological treatment

Exclusion Criteria:

* IQ\<85
* Bipolar Dissorder, Schizophrenia, Psicotic Disorders, Substance Abuse Disorder, Personality Disorders
* Suicidity Ideation
* Serious Organic desease
* Participate in other Psychological Treatment during the study

Primary outcomes:
measure: Change in the ADHD-Rating Scale (ADHD-RS)
timeFrame: 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.
measure: Change in the Clinical Global Impression - Severity (CGI-S)
timeFrame: 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.
Secondary outcomes:
measure: To assess the severity of ADHD symptons
timeFrame: at Baseline
measure: To assess the severity of ADHD symptons
timeFrame: at Baseline
measure: To assess the ADHD symptons at childhood
timeFrame: at Baseline
measure: To assess the Health status
timeFrame: at Baseline
measure: Change in the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: 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.
measure: Change in the Functioning Assessment Short Test (FAST)
timeFrame: 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.
measure: Change in the Beck Depression Inventory (BDI-II)
timeFrame: 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.
measure: Change in the State-Trait Anxiety Inventory (STAI)
timeFrame: 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.
Other outcomes:
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