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

NCT01659164 | Completed

• 1 other identifier: 2012/333-31
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Cognitive Behavioral Therapy; Dialectical Behavioral Therapy; Group Treatment; ADHD

Outcome Measures

Primary Outcomes (1)

• Change (from baseline) in ASRS- v 1.1

  ADHD Self Report Scale (self rating)

  14 weeks (post)

Secondary Outcomes (7)

• Change (from baseline) in ADHD Rating Scale

  14 weeks (post)

• Change (from baseline) in EQ-5D

  14 weeks (post)

• Change (from baseline) in ISI

  14 weeks (post)

• Change (from baseline) in PSS-4

  14 weeks (post)

• Change (from baseline) in Sheehan Disability Scale

  14 weeks (post)

Other Outcomes (1)

• Treatment evaluation

  14 weeks (post)

Study Arms (1)

Group treatment (uncontrolled)

EXPERIMENTAL

Psychological treatment in group for adults with ADHD (pilot) during 14 weeks with focus on decreasing disabilities due to the condition.

Behavioral: Group treatment for adults with ADHD

Interventions

Group treatment for adults with ADHD BEHAVIORAL

14 weeks of group treatment for adults with ADHD

Group treatment (uncontrolled)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* Clinical diagnosis of AD/HD
• \* Age 18-65
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Internetpsykiatrienheten, Psykiatri Sydväst, SLSO

Stockholm, Sweden

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Viktor Kaldo, Ph.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 7, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

SE (1)