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CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders

Primary Purpose

Attention Deficit Hyperactivity Disorder, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
cognitive behavioral therapy for treating ADHD symptoms
Sponsored by
Arkin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, SUD, cognitive behavioral therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • substance use disorder
  • ADHD
  • able to comply with study activities

Exclusion Criteria:

  • severe neurological or psychiatric diseases (for example Parkinson, dementia, psychosis, bipolar depression) which require medication
  • unable to read or write Dutch language

Sites / Locations

  • Arkin

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard addiction treatment

addiction treatment and ADHD treatment

Arm Description

10 sessions of standard addiction treatment. No ADHD treatment.

10 sessions cognitive behavioral therapy on addiction treatment combined with 5 sessions on ADHD treatment.

Outcomes

Primary Outcome Measures

self reported ADHD symptoms
Dutch self report list of ADHD symptoms by Kooij and Buitelaar

Secondary Outcome Measures

Time Line Follow Back method
self-reported alcohol and drug use
Beck depression inventory
self reported depression symptoms
Beck Anxiety Inventory
Self reported anxiety symptoms
EQ-5
Self reported quality of living
TIC-P
health care consumption and production loss in relation to mental health problems
Stroop task
neuropsychological measure
Tower of London task
neuropsychological task
BART task
neuropsychological task on risk taking behavior
urine checks
urine checks on drug use

Full Information

First Posted
September 8, 2011
Last Updated
January 13, 2017
Sponsor
Arkin
Collaborators
Fonds NutsOhra
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1. Study Identification

Unique Protocol Identification Number
NCT01431235
Brief Title
CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders
Official Title
Investigating the Efficacy of Cognitive Behavioral Therapy in Patients With Substance Use Disorder and Comorbid ADHD. A Randomized Controlled Trial With Cognitive Behavioral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkin
Collaborators
Fonds NutsOhra

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.
Detailed Description
Attention Deficit Hyperactivity Disorder(ADHD) is an important comorbid condition in patients with substance use disorders (SUD). The prevalence of ADHD in patients with SUD is estimated 23%, and ADHD is associated with an untoward prognosis of SUD. However, adequate treatment programs for patients with ADHD and SUD are not available. Results of medication trials for patients with ADHD and SUD are disappointing, and cognitive behavioral therapy (CBT) has not yet been investigated in this population. In patients with ADHD without comorbid SUD, the results of CBT in randomized trials are positive. The purpose of this study is to investigate if CBT is effective in treating ADHD symptoms in patients with ADHD and SUD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Substance Use Disorders
Keywords
ADHD, SUD, cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard addiction treatment
Arm Type
No Intervention
Arm Description
10 sessions of standard addiction treatment. No ADHD treatment.
Arm Title
addiction treatment and ADHD treatment
Arm Type
Experimental
Arm Description
10 sessions cognitive behavioral therapy on addiction treatment combined with 5 sessions on ADHD treatment.
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy for treating ADHD symptoms
Intervention Description
5 sessions of one hour CBT for treating ADHD symptoms by a trained health care worker
Primary Outcome Measure Information:
Title
self reported ADHD symptoms
Description
Dutch self report list of ADHD symptoms by Kooij and Buitelaar
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time Line Follow Back method
Description
self-reported alcohol and drug use
Time Frame
6 months
Title
Beck depression inventory
Description
self reported depression symptoms
Time Frame
6 months
Title
Beck Anxiety Inventory
Description
Self reported anxiety symptoms
Time Frame
6 months
Title
EQ-5
Description
Self reported quality of living
Time Frame
6 months
Title
TIC-P
Description
health care consumption and production loss in relation to mental health problems
Time Frame
6 months
Title
Stroop task
Description
neuropsychological measure
Time Frame
6 months
Title
Tower of London task
Description
neuropsychological task
Time Frame
6 months
Title
BART task
Description
neuropsychological task on risk taking behavior
Time Frame
6 months
Title
urine checks
Description
urine checks on drug use
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: substance use disorder ADHD able to comply with study activities Exclusion Criteria: severe neurological or psychiatric diseases (for example Parkinson, dementia, psychosis, bipolar depression) which require medication unable to read or write Dutch language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Schoevers, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkin
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
18558465
Citation
Arias AJ, Gelernter J, Chan G, Weiss RD, Brady KT, Farrer L, Kranzler HR. Correlates of co-occurring ADHD in drug-dependent subjects: prevalence and features of substance dependence and psychiatric disorders. Addict Behav. 2008 Sep;33(9):1199-207. doi: 10.1016/j.addbeh.2008.05.003. Epub 2008 May 13.
Results Reference
background
PubMed Identifier
21254791
Citation
Castells X, Ramos-Quiroga JA, Rigau D, Bosch R, Nogueira M, Vidal X, Casas M. Efficacy of methylphenidate for adults with attention-deficit hyperactivity disorder: a meta-regression analysis. CNS Drugs. 2011 Feb;25(2):157-69. doi: 10.2165/11539440-000000000-00000.
Results Reference
background
PubMed Identifier
20736471
Citation
Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.
Results Reference
background
PubMed Identifier
20231319
Citation
Solanto MV, Marks DJ, Wasserstein J, Mitchell K, Abikoff H, Alvir JM, Kofman MD. Efficacy of meta-cognitive therapy for adult ADHD. Am J Psychiatry. 2010 Aug;167(8):958-68. doi: 10.1176/appi.ajp.2009.09081123. Epub 2010 Mar 15.
Results Reference
background
PubMed Identifier
23663651
Citation
van Emmerik-van Oortmerssen K, Vedel E, Koeter MW, de Bruijn K, Dekker JJ, van den Brink W, Schoevers RA. Investigating the efficacy of integrated cognitive behavioral therapy for adult treatment seeking substance use disorder patients with comorbid ADHD: study protocol of a randomized controlled trial. BMC Psychiatry. 2013 May 10;13:132. doi: 10.1186/1471-244X-13-132.
Results Reference
derived

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CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders

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