Skip to main content
OpenTrials
Completed

NCT Number: NCT01659164

Psychological Treatment for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

The purpose of this uncontrolled pilot study is to develop and make an initial evaluation of a new treatment manual for treatment of ADHD in adults. The objectives in the treatment is to build relational skills, skills in organizing and structuring everyday life, handle difficult emotions and impulses etc. The treatment will be in a group format and it is hypothesized that the psychological intervention will result in reduced ADHD symptoms and to decreased experience of stress and depressive symptoms. The uncontrolled design does not allow for any causal inferences from the results, this pilot study is primarily to be seen as a preparation before a subsequent RCT.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internetpsykiatrienheten, Psykiatri Sydväst, SLSO

Stockholm, Sweden

About this study

Approximately one-third of children with ADHD continue to be fully symptomatic into adulthood and many of the remainders often retain some residual problems that require treatment. Thus ADHD is a prevalent and chronic disabling disorder. Drugs provide first line treatment for adults with ADHD but are not enough for everybody, while we still lack proper evidence for promising psychological treatment. In addition to core symptoms of ADHD including regulatory difficulties of attention, activity level and impulses, difficulties with emotional regulation are common.

Follow-up studies of adults with ADHD have shown that only a few patients were offered sufficient treatment and support after the neuropsychiatric assessment and testing. The majority of adults diagnosed with ADHD are offered pharmacological treatment (stimulant medication) as the sole treatment. However, stimulant medication is not effective for up to 20-50 percent of adults as they may not experience symptom reduction or they are unable to tolerate the medication.

Consequently, the possible benefits of identifying and treating individuals with ADHD are extensive. Treatment of ADHD is preferably multimodal, i.e. consisting of more than one intervention.

There has been limited research to date concerning psychosocial treatments for adult ADHD. Studies of cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT) show that structured short-term therapies are promising in reducing ADHD related symptoms and increasing life quality. Focus in the CBT treatment is to build skills, increasing and compensating for deficits in the executive functioning due to impairments of the frontal lobe. DBT combines change-oriented skills from CBT with acceptance-oriented skills and core mindfulness skills. DBT skills have been tried out and validated as a promising intervention package for adults with ADHD through the research of Steven Safren and Bernd Hesslinger.

The objective of the planned study is to evaluate a new manual for group treatment, with a combination of treatment methods from Safrens and Hesslingers evidence-based treatment manuals. The aim of the pilot project is to create a clinically effective combination of the different methods of treatment, with a high degree of understanding, acceptance, use and perceived usefulness of the patients undergoing treatment. Both qualitative and quantitative data about patients' perceptions and use of the different methods will be collected during and after treatment to increase knowledge of how treatments can be developed and combined in order to better match the needs of patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • * Clinical diagnosis of AD/HD
  • * Age 18-65
  • 17 or more on the Adult ADHD Self Report Scale (ASRS v1.1)
  • Not medically treated for adhd symptoms, or medically treated with central stimulants or comparable substance since at least one month with no significant changes in dosage and where no change in medical treatment is anticipated during the study time frame for the participant.
  • No change in any other medical treatment is anticipated during the study time frame for the participant.
  • Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
  • The participant hasn´t used drugs the last 3 months.

Exclusion criteria

  • Diagnosed substance abuse according to DSM-IV criteria within 3 months prior to screening. Earlier episodic substance abuse is not excluding
  • Co-existing psychiatric condition that investigators believe will unable the participant to follow through the training protocol and take part in measures taken during the study time frame.
  • IQ ≤70 according to a neuropsychological assessment
  • * Suicidality risk which is assessed during the first assessment interview.
  • Organic brain syndrome
  • Serious somatic condition which will unable the participant to participate (through the training protocol)or, is anticipated to have a negative impact on the treatment results
  • Autism spectrum disorder (severe)
  • Severe depression
  • Other current psychological treatment for AD/HD

Treatment and study plan

Group treatment for adults with ADHD

Behavioral

14 weeks of group treatment for adults with ADHD

Primary outcomes

  1. Change (from baseline) in ASRS- v 1.1

    Time frame: 14 weeks (post)

    ADHD Self Report Scale (self rating)

Secondary outcomes

  1. Change (from baseline) in ADHD Rating Scale

    Time frame: 14 weeks (post)

    ADHD Rating Scale - assessed by a clinician

  2. Change (from baseline) in EQ-5D

    Time frame: 14 weeks (post)

    Euroqol - (self report) to measure general health and quality of life

  3. Change (from baseline) in ISI

    Time frame: 14 weeks (post)

    Insomnia Severity Index - (self report) to measure insomnia symptoms

  4. Change (from baseline) in PSS-4

    Time frame: 14 weeks (post)

    Perceived Stress Scale - (self report) to measure level of stress in everyday life

  5. Change (from baseline) in Sheehan Disability Scale

    Time frame: 14 weeks (post)

    Sheehan Disability Scale - (self report) to measure level of disability in everyday life

  6. Change (from baseline) in MADRS-S

    Time frame: 14 weeks (post)

    Montgomery-Åsberg Depression Rating Scale - (self report) to measure level of depression

  7. Change (from baseline) in DERS

    Time frame: 14 weeks (post)

    Difficulties of Emotion Regulation Scale - (self report)

Other outcomes

  1. Treatment evaluation

    Time frame: 14 weeks (post)

    The investigators design own questions in order to evaluate how the participants have experienced the intervention regarding to knowledge, usage of the treatment methods and possible difficulties that they have experienced during treatment. Our aim is to use these evaluations to evolve and improve the quality of the treatment manual.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Psychological Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) - Pilot Evaluation of a New Treatment Manual Based on CBT and DBT

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2012
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.