Substance-Related DisordersNCT00334217
Cognitive Remediation in Early Substance Abuse Treatment
A study testing Cognitive Remediation in people with Substance-Related Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study is for the purpose of determining whether cognitive remediation may improve cognition and treatment response in patients entering substance abuse day treatment Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veterans participating in a substance abuse day treatment program at the Errara Community Center
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
Official title: Cognitive Remediation in the Initial Phase of Substance Abuse Treatment: Feasibility and Efficacy
This study is for the purpose of determining whether cognitive remediation may improve cognition and treatment response in patients entering substance abuse day treatment
Read the detailed description
Background: Patients entering substance abuse treatment display cognitive deficits that may reduce their ability to benefit from their treatment. While there is considerable variety in the severity and types of cognitive impairment found in newly recovering patients, problems with attention, memory and executive function are very common. Since treatment requires sustained attention, remembering what is learned, integrating that knowledge and applying it to recovery, impairment in underlying cognitive processes makes successful treatment less likely. Although cognitive functioning improves with sustained sobriety, it is during the early phase of recovery that most patients receive the most intensive treatment. Recent research has suggested that cognitive remediation exercises during this early phase may speed up the return of cognitive functioning and in so doing may have a direct effect on whether patients find the treatment useful and complete their treatment. By keeping patients in treatment longer, cognitive remediation may have an indirect effect on substance abuse outcomes.
Objectives: To pilot test the introduction of cognitive remediation at the Substance Abuse Day Treatment Program (SADP) at the Errara Community Care Center. Aims are 1) to assess the receptivity of patients to the intervention by determining rates of agreement to participate, 2) to determine the number of cognitive remediation sessions that patients are willing to engage in, 3) to assess a variety of cognitive remediation tasks for their acceptability, 4) to evaluate neuropsychological improvements using pre-post assessment, 5) to evaluate its effects on substance abuse treatment participation, and 6) to evaluate its effects on substance abuse outcomes at 6 months follow-up.
Design: Randomized clinical trial of cognitive remediation with an active control condition with observations at baseline, end of treatment and 6-months from intake
- Conditions
- Substance-Related Disorders
- Being tested
- Cognitive Remediation
- Keywords
- Psychology: cognitive aspects, Substance-Related Disorders, treatment efficacy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationBehavioural
PSS Cogrehab
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PSS CogRehab exercises Receives: Behavioral: Cognitive Remediation |
| 2 | No intervention | On-line computer games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive improvement and adherence to substance abuse treatment
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startAug 2005
- Primary completionAug 2007
- Study completionDec 2008
Why it stopped: The intervention could not be successfully carried out in the SADP setting because of issues independent of the cognitive training intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Morris D Bell, PhD, Principal investigator, VA Connecticut Health Care System (West Haven)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334217
- Sponsor's protocol ID
- O3108R
- Status last verified
- Jun 2009
- First submitted
- 2 Jun 2006
- Last updated
- 18 Jun 2009
- Results posted
- No
Publications
Horner MD, Harvey RT, Denier CA. Self-report and objective measures of cognitive deficit in patients entering substance abuse treatment. Psychiatry Res. 1999 May 31;86(2):155-61. doi: 10.1016/s0165-1781(99)00031-1.
PubMed 10397417Teichner G, Horner MD, Roitzsch JC, Herron J, Thevos A. Substance abuse treatment outcomes for cognitively impaired and intact outpatients. Addict Behav. 2002 Sep-Oct;27(5):751-63. doi: 10.1016/s0306-4603(01)00207-6.
PubMed 12201382Grohman K, Fals-Stewart W. The detection of cognitive impairment among substance-abusing patients: the accuracy of the neuropsychological assessment battery-screening module. Exp Clin Psychopharmacol. 2004 Aug;12(3):200-7. doi: 10.1037/1064-1297.12.3.200.
PubMed 15301637O'Malley S, Adamse M, Heaton RK, Gawin FH. Neuropsychological impairment in chronic cocaine abusers. Am J Drug Alcohol Abuse. 1992;18(2):131-44. doi: 10.3109/00952999208992826.
PubMed 1562011
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation in the Initial Phase of Substance Abuse Treatment: Feasibility and Efficacy
- ClinicalTrials.gov ID
- NCT00334217
- Acronym / sponsor ID
- O3108R
- Conditions
- Substance-Related Disorders
- Keywords
- Psychology: cognitive aspects, Substance-Related Disorders, treatment efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The intervention could not be successfully carried out in the SADP setting because of issues independent of the cognitive training intervention.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for the purpose of determining whether cognitive remediation may improve cognition and treatment response in patients entering substance abuse day treatment
Detailed description
Background: Patients entering substance abuse treatment display cognitive deficits that may reduce their ability to benefit from their treatment. While there is considerable variety in the severity and types of cognitive impairment found in newly recovering patients, problems with attention, memory and executive function are very common. Since treatment requires sustained attention, remembering what is learned, integrating that knowledge and applying it to recovery, impairment in underlying cognitive processes makes successful treatment less likely. Although cognitive functioning improves with sustained sobriety, it is during the early phase of recovery that most patients receive the most intensive treatment. Recent research has suggested that cognitive remediation exercises during this early phase may speed up the return of cognitive functioning and in so doing may have a direct effect on whether patients find the treatment useful and complete their treatment. By keeping patients in treatment longer, cognitive remediation may have an indirect effect on substance abuse outcomes.
Objectives: To pilot test the introduction of cognitive remediation at the Substance Abuse Day Treatment Program (SADP) at the Errara Community Care Center. Aims are 1) to assess the receptivity of patients to the intervention by determining rates of agreement to participate, 2) to determine the number of cognitive remediation sessions that patients are willing to engage in, 3) to assess a variety of cognitive remediation tasks for their acceptability, 4) to evaluate neuropsychological improvements using pre-post assessment, 5) to evaluate its effects on substance abuse treatment participation, and 6) to evaluate its effects on substance abuse outcomes at 6 months follow-up.
Design: Randomized clinical trial of cognitive remediation with an active control condition with observations at baseline, end of treatment and 6-months from intake
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive RemediationPSS CogRehab exercises |
| 2 | No intervention | –On-line computer games |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans participating in a substance abuse day treatment program at the Errara Community Center
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RemediationPSS Cogrehab | Behavioural | 1 |
Primary outcome
Cognitive improvement and adherence to substance abuse treatment
Time frame: 6 month follow-up
Results and safety
The study was stopped early (reason given: The intervention could not be successfully carried out in the SADP setting because of issues independent of the cognitive training intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2009.
- Results publication: PubMed 10397417Horner MD, Harvey RT, Denier CA. Self-report and objective measures of cognitive deficit in patients entering substance abuse treatment. Psychiatry Res. 1999 May 31;86(2):155-61. doi: 10.1016/s0165-1781(99)00031-1.
- Results publication: PubMed 12201382Teichner G, Horner MD, Roitzsch JC, Herron J, Thevos A. Substance abuse treatment outcomes for cognitively impaired and intact outpatients. Addict Behav. 2002 Sep-Oct;27(5):751-63. doi: 10.1016/s0306-4603(01)00207-6.
- Results publication: PubMed 15301637Grohman K, Fals-Stewart W. The detection of cognitive impairment among substance-abusing patients: the accuracy of the neuropsychological assessment battery-screening module. Exp Clin Psychopharmacol. 2004 Aug;12(3):200-7. doi: 10.1037/1064-1297.12.3.200.
- Results publication: PubMed 1562011O'Malley S, Adamse M, Heaton RK, Gawin FH. Neuropsychological impairment in chronic cocaine abusers. Am J Drug Alcohol Abuse. 1992;18(2):131-44. doi: 10.3109/00952999208992826.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morris D Bell, PhD principal investigator
VA Connecticut Health Care System (West Haven)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation in people with Substance-Related Disorders, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The intervention could not be successfully carried out in the SADP setting because of issues independent of the cognitive training intervention.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive improvement and adherence to substance abuse treatment (time frame: 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00334217, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2009.