NCT01431235

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

5.3 years

First QC Date

September 8, 2011

Last Update Submit

January 13, 2017

Conditions

Attention Deficit Hyperactivity DisorderSubstance Use Disorders

Keywords

ADHDSUDcognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • self reported ADHD symptoms

    Dutch self report list of ADHD symptoms by Kooij and Buitelaar

    6 months

Secondary Outcomes (9)

  • Time Line Follow Back method

    6 months

  • Beck depression inventory

    6 months

  • Beck Anxiety Inventory

    6 months

  • EQ-5

    6 months

  • TIC-P

    6 months

  • +4 more secondary outcomes

Study Arms (2)

standard addiction treatment

NO INTERVENTION

10 sessions of standard addiction treatment. No ADHD treatment.

addiction treatment and ADHD treatment

EXPERIMENTAL

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

Behavioral: cognitive behavioral therapy for treating ADHD symptoms

Interventions

cognitive behavioral therapy for treating ADHD symptomsBEHAVIORAL

5 sessions of one hour CBT for treating ADHD symptoms by a trained health care worker

addiction treatment and ADHD treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkin

Amsterdam, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 18558465BACKGROUND

  • 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.

    PMID: 21254791BACKGROUND

  • 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.

    PMID: 20736471BACKGROUND

  • 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.

    PMID: 20231319BACKGROUND

  • 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.

    PMID: 23663651DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySubstance-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robert Schoevers, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 9, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 16, 2017

Record last verified: 2017-01

Locations

NL(1)