Psychological Treatment for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Group treatment for adults with ADHD
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, Group Treatment, ADHD
Eligibility Criteria
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
Sites / Locations
- Internetpsykiatrienheten, Psykiatri Sydväst, SLSO
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group treatment (uncontrolled)
Arm Description
Psychological treatment in group for adults with ADHD (pilot) during 14 weeks with focus on decreasing disabilities due to the condition.
Outcomes
Primary Outcome Measures
Change (from baseline) in ASRS- v 1.1
ADHD Self Report Scale (self rating)
Secondary Outcome Measures
Change (from baseline) in ADHD Rating Scale
ADHD Rating Scale - assessed by a clinician
Change (from baseline) in EQ-5D
Euroqol - (self report) to measure general health and quality of life
Change (from baseline) in ISI
Insomnia Severity Index - (self report) to measure insomnia symptoms
Change (from baseline) in PSS-4
Perceived Stress Scale - (self report) to measure level of stress in everyday life
Change (from baseline) in Sheehan Disability Scale
Sheehan Disability Scale - (self report) to measure level of disability in everyday life
Change (from baseline) in MADRS-S
Montgomery-Åsberg Depression Rating Scale - (self report) to measure level of depression
Change (from baseline) in DERS
Difficulties of Emotion Regulation Scale - (self report)
Full Information
NCT ID
NCT01659164
First Posted
August 3, 2012
Last Updated
April 1, 2015
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT01659164
Brief Title
Psychological Treatment for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
Psychological Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) - Pilot Evaluation of a New Treatment Manual Based on CBT and DBT
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, Group Treatment, ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group treatment (uncontrolled)
Arm Type
Experimental
Arm Description
Psychological treatment in group for adults with ADHD (pilot) during 14 weeks with focus on decreasing disabilities due to the condition.
Intervention Type
Behavioral
Intervention Name(s)
Group treatment for adults with ADHD
Intervention Description
14 weeks of group treatment for adults with ADHD
Primary Outcome Measure Information:
Title
Change (from baseline) in ASRS- v 1.1
Description
ADHD Self Report Scale (self rating)
Time Frame
14 weeks (post)
Secondary Outcome Measure Information:
Title
Change (from baseline) in ADHD Rating Scale
Description
ADHD Rating Scale - assessed by a clinician
Time Frame
14 weeks (post)
Title
Change (from baseline) in EQ-5D
Description
Euroqol - (self report) to measure general health and quality of life
Time Frame
14 weeks (post)
Title
Change (from baseline) in ISI
Description
Insomnia Severity Index - (self report) to measure insomnia symptoms
Time Frame
14 weeks (post)
Title
Change (from baseline) in PSS-4
Description
Perceived Stress Scale - (self report) to measure level of stress in everyday life
Time Frame
14 weeks (post)
Title
Change (from baseline) in Sheehan Disability Scale
Description
Sheehan Disability Scale - (self report) to measure level of disability in everyday life
Time Frame
14 weeks (post)
Title
Change (from baseline) in MADRS-S
Description
Montgomery-Åsberg Depression Rating Scale - (self report) to measure level of depression
Time Frame
14 weeks (post)
Title
Change (from baseline) in DERS
Description
Difficulties of Emotion Regulation Scale - (self report)
Time Frame
14 weeks (post)
Other Pre-specified Outcome Measures:
Title
Treatment evaluation
Description
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.
Time Frame
14 weeks (post)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktor Kaldo, Ph.D.
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internetpsykiatrienheten, Psykiatri Sydväst, SLSO
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
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Psychological Treatment for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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