NCT04588181

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2.7 years

First QC Date

September 23, 2020

Last Update Submit

October 8, 2020

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

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

    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.

    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 Clinical Global Impression - Severity (CGI-S)

    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 (8)

  • To assess the severity of ADHD symptons

    at Baseline

  • To assess the severity of ADHD symptons

    at Baseline

  • To assess the ADHD symptons at childhood

    at Baseline

  • To assess the Health status

    at Baseline

  • 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.

  • +3 more secondary outcomes

Study Arms (2)

CBT 6 sessions

EXPERIMENTAL
Behavioral: cognitive behavioral therapy (CBT)

CBT 12 sessions

ACTIVE COMPARATOR
Behavioral: cognitive behavioral therapy (CBT)

Interventions

cognitive behavioral therapy (CBT)BEHAVIORAL

Cognitive behavioral therapy (CBT) is a psycho-social intervention that aims to improve mental health. CBT focuses on challenging and changing unhelpful cognitive distortions (e.g. thoughts, beliefs, and attitudes) and behaviors, improving emotional regulation, and the development of personal coping strategies that target solving current problems.

CBT 12 sessionsCBT 6 sessions

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Psychiatry Department

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 19, 2020

Study Start

July 25, 2016

Primary Completion

March 28, 2019

Study Completion

May 16, 2019

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share