Alcohol Use DisorderICTNCT02598518
Integrating Combined Therapies for Persons With Co-occurring Disorders
A study testing Integrating Combined Therapies in people with Alcohol Use Disorder and Mental Health Disorder, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness and implementability of ICT for co-occurring alcohol use and mental health disorders within community addiction treatment, as delivered by routine community addiction clinicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Mental Health Disorder
- What is being tested?
- Integrating Combined Therapies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 31 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old;
- Evaluated and admitted to outpatient addiction treatment services at RMHS Evergreen program and meets criteria for any alcohol or substance use disorder;
- Screened positive for an alcohol problem on the Alcohol Use Disorders Identification Test (AUDIT) (score of 8 or higher) (screening instrument);
- Screened positive for a mental health problem on the Modified MINI Screen (MMS) (score of 6 or higher) (screening instrument);
- Diagnoses confirmed by SCID (diagnostic interview); AND
- Willing and able to provide informed consent.
Who cannot join
- They have acute psychotic symptoms and are not appropriately connected with mental health services;
- They have had a psychiatric hospitalization or suicide attempt within the past month (however, if the hospitalization or attempt was directly related to substance intoxication or detoxification and the person is currently stable, they are eligible); OR
- They have unstable medical or legal situations that would make participation for the full duration of the study highly unlikely.
Trial locations and contacts
1 site in 1 country.
United States1 site
Evergreen - Rutland Mental Health
Rutland, Vermont, 05701
About this study
The purpose of this study is to assess the effectiveness and implementability of ICT for co-occurring alcohol use and mental health disorders within community addiction treatment, as delivered by routine community addiction clinicians.
Read the detailed description
The proposed study will evaluate the effectiveness and implementability of a manual-guided integrated psychosocial treatment, Integrating Combined Therapies (ICT). ICT is an adaptation of the Combined Behavioral Intervention (CBI) from NIAAA Project COMBINE, and expands CBI's indication for alcohol problems to extend to drug use and the most common psychiatric problems in addiction treatment. ICT is designed to be transferable to routine care settings and for delivery by the existing workforce. Findings from a 2014 study provide a signal for ICT effectiveness and implementation.
We intend to randomly assign 76 eligible patients in outpatient addiction treatment to ICT adapted standard care (ICT+SC) versus standard care only (SC). There are 2 specific aims for this study:
Aim 1: Relative to standard care alone, to evaluate if patients receiving ICT have more significant reductions in alcohol use and severity as measured by the 90-day Timeline Follow Back (TLFB), Addiction Severity Index (ASI), and Short Inventory of Problems (SIP).
Aim 2: Relative to standard care alone, to evaluate if patients receiving ICT have more significant reductions in psychiatric symptom severity, as measured by the Brief Symptom Inventory (BSI) adn the ASI psychiatric severity composite.
This study involves a two-group repeated measure design. This study is a randomized controlled trial. The investigators plan to examine the outcomes associated with ICT versus standard care among patients receiving outpatient addiction treatment services. The investigators will employ assessments at baseline, four-month follow-up, and seven-month follow-up. Eligible participants will be randomly assigned to ICT therapy (plus standard care) or standard care, and all will be followed for the research assessments regardless of whether they drop out of treatment early (whenever possible).
Patients admitted to the participating addiction treatment program are routinely screened for an alcohol use disorder using the AUDIT and a mental health disorder using the MMS. These forms are collected by clinic staff and scored for alcohol use disorder (AUDIT: 8 or greater) and mental health disorder (MMS: 6 or greater). Patients meeting the threshold criteria on the AUDIT and MMS measures are approached by clinic staff about potential interest in the study. If they wish to learn more about the study, the research assistant is contacted, a suitable time is arranged, and the patient engaged in the process of informed consent.
If consent is granted, the participant completes the baseline assessment. The baseline assessment consists of measures gathered via interview by a member of the research team, self-administered surveys completed directly by the participant, and review of the participant's medical record to extract substance use, treatment history, and chart diagnoses.
The interview portion of the assessment consists of :
- Standardized interview designed to assess mental health diagnoses: Structured Clinical Interview for DSM5 (SCID).
- A urine screen and breathalyzer to test for alcohol and other drugs.
- Standardized follow-back method for gathering data on recent alcohol and drug use: Timeline Follow-back calendar (TLFB)
The self-administered portion of the assessment consists of measures designed to assess:
- Alcohol and drug use, as well as associated problems in other life areas such as medical, employment, legal, social, and psychiatric: Addiction Severity Index
- Psychiatric symptoms: Brief Symptom Inventory (BSI)
- Mental health disorders: Modified MINI Screen (MMS)
- Negative consequences of alcohol and substance use: Short Inventory of Problems- Alcohol and Drugs (SIP-AD)
- Substance use symptoms and problems: Brief Addiction Monitor (BAM)
- Treatment utilization: Recent Treatment Survey (RTS)
If the participant continues to meet criteria for a mental health disorder (i.e. SCID interview confirms diagnosis of DSM5 mental health disorder, he or she is randomized to receive the study ICT therapy or standard care (SC)
Research assessments are then also conducted at four months and seven months post baseline assessment. The follow-up assessments will consist of the same measures administered at baseline, with the exception of the SCID interview.
The investigators plan to randomize approximately 76 participants in the study.
- Conditions
- Alcohol Use Disorder, Mental Health Disorder
- Being tested
- Integrating Combined Therapies, Standard Care
- Keywords
- Integrating Combined Therapies, Alcohol Use Disorder, Mental Health Disorder
- Medical subject headings
- Alcoholism, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrating Combined TherapiesBehavioural
Also called ICT
Individual Integrating Combined Therapies, approximately 10 sessions, one session per week
Standard CareBehavioural
Also called SC
Standard Care, individual or group therapy, approximately 9 hours per week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Integrating Combined Therapies | Experimental | Integrating Combined Therapies (ICT) is a 10-session, manual-guided individual therapy. ICT has three phases designed to address substance use, psychiatric problems and their interactions. MET is the first phase (2 sessions) and is focused on assessment, feedback and securing motivation to address problems and take steps. CBT is the second phase (5 sessions) and incorporates patient education and functional analysis, develops coping skills, teaches methods to challenge beliefs, and activates alternative behaviors. TSF (3 sessions) is focused on maintaining recovery and engaging in community-based recovery activities. Although ICT has core components, its application is flexible to accommodate the unique needs and problems of individual patients (and their comorbidities). Receives: Behavioral: Integrating Combined Therapies |
| Standard Care | Active comparator | Standard Care (SC) is the typical outpatient treatment that the patient would receive ordinarily at the identified addiction treatment program. SC service operates using the American Society of Addiction Medicine criteria (9 hours per week); group and individual sessions focused on motivation to address substance use, education about the consequences of substance use on major life areas, education about the disease concept and brain changes associated with addiction, exposure to information about social and family relationships and recovery, and relapse prevention skills. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease from baseline in alcohol use (90-day Timeline Follow Back (TLFB) at 4-months and at 7-months
Measured: Baseline, 4-month, 7-month follow-up
Decrease from baseline in alcohol use severity (ASI; alcohol severity composite) at 4-months and at 7-months
Measured: Baseline, 4-month, 7-month follow-up
Decrease from baseline in alcohol use severity (Short Inventory of Problems (SIP)) at 4-months and at 7-months
Measured: Baseline, 4-month, 7-month follow-up
Decrease from baseline in psychiatric symptom severity (ASI; Psychiatric Severity Composite) at 4-months and at 7-months
Measured: Baseline, 4-month, 7-month follow-up
Decrease in psychiatric symptom severity (Brief Symptom Inventory (BSI)) at 4-months and 7-months
Measured: Baseline, 4-month, 7-month follow-up
Secondary outcomes (3)
Decrease from baseline in drug use (90-day TLFB) at 4-months and at 7-months
Measured: Baseline, 4-month, 7-month follow-up
Decrease from baseline in positive toxicology screen (urine drug screen) at 4-months and at 7-months
Measured: Baseline, 4-month, 7-month follow-up
Decrease from baseline in drug use severity (ASI; Drug Severity Composite) at 4-months and 7-months
Measured: Baseline, 4-month, 7-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 Nov 2015 (estimated)
- Study startJul 2015
- Primary completion30 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Mark McGovern, Stanford University
- Investigators
- Mark P. McGovern, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598518
- Sponsor's protocol ID
- 1R21AA023001-01A1
- Other IDs
- 1R21AA023001-01A1
- Acronym
- ICT
- Status last verified
- Jun 2018
- First submitted
- 27 Oct 2015
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Combined Therapies for Persons With Co-occurring Disorders
- ClinicalTrials.gov ID
- NCT02598518
- Acronym / sponsor ID
- ICT / 1R21AA023001-01A1
- Conditions
- Alcohol Use Disorder, Mental Health Disorder
- Keywords
- Integrating Combined Therapies, Alcohol Use Disorder, Mental Health Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2015
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Nov 2015 (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.
The purpose of this study is to assess the effectiveness and implementability of ICT for co-occurring alcohol use and mental health disorders within community addiction treatment, as delivered by routine community addiction clinicians.
Detailed description
The proposed study will evaluate the effectiveness and implementability of a manual-guided integrated psychosocial treatment, Integrating Combined Therapies (ICT). ICT is an adaptation of the Combined Behavioral Intervention (CBI) from NIAAA Project COMBINE, and expands CBI's indication for alcohol problems to extend to drug use and the most common psychiatric problems in addiction treatment. ICT is designed to be transferable to routine care settings and for delivery by the existing workforce. Findings from a 2014 study provide a signal for ICT effectiveness and implementation.
We intend to randomly assign 76 eligible patients in outpatient addiction treatment to ICT adapted standard care (ICT+SC) versus standard care only (SC). There are 2 specific aims for this study:
Aim 1: Relative to standard care alone, to evaluate if patients receiving ICT have more significant reductions in alcohol use and severity as measured by the 90-day Timeline Follow Back (TLFB), Addiction Severity Index (ASI), and Short Inventory of Problems (SIP).
Aim 2: Relative to standard care alone, to evaluate if patients receiving ICT have more significant reductions in psychiatric symptom severity, as measured by the Brief Symptom Inventory (BSI) adn the ASI psychiatric severity composite.
This study involves a two-group repeated measure design. This study is a randomized controlled trial. The investigators plan to examine the outcomes associated with ICT versus standard care among patients receiving outpatient addiction treatment services. The investigators will employ assessments at baseline, four-month follow-up, and seven-month follow-up. Eligible participants will be randomly assigned to ICT therapy (plus standard care) or standard care, and all will be followed for the research assessments regardless of whether they drop out of treatment early (whenever possible).
Patients admitted to the participating addiction treatment program are routinely screened for an alcohol use disorder using the AUDIT and a mental health disorder using the MMS. These forms are collected by clinic staff and scored for alcohol use disorder (AUDIT: 8 or greater) and mental health disorder (MMS: 6 or greater). Patients meeting the threshold criteria on the AUDIT and MMS measures are approached by clinic staff about potential interest in the study. If they wish to learn more about the study, the research assistant is contacted, a suitable time is arranged, and the patient engaged in the process of informed consent.
If consent is granted, the participant completes the baseline assessment. The baseline assessment consists of measures gathered via interview by a member of the research team, self-administered surveys completed directly by the participant, and review of the participant's medical record to extract substance use, treatment history, and chart diagnoses.
The interview portion of the assessment consists of :
- Standardized interview designed to assess mental health diagnoses: Structured Clinical Interview for DSM5 (SCID).
- A urine screen and breathalyzer to test for alcohol and other drugs.
- Standardized follow-back method for gathering data on recent alcohol and drug use: Timeline Follow-back calendar (TLFB)
The self-administered portion of the assessment consists of measures designed to assess:
- Alcohol and drug use, as well as associated problems in other life areas such as medical, employment, legal, social, and psychiatric: Addiction Severity Index
- Psychiatric symptoms: Brief Symptom Inventory (BSI)
- Mental health disorders: Modified MINI Screen (MMS)
- Negative consequences of alcohol and substance use: Short Inventory of Problems- Alcohol and Drugs (SIP-AD)
- Substance use symptoms and problems: Brief Addiction Monitor (BAM)
- Treatment utilization: Recent Treatment Survey (RTS)
If the participant continues to meet criteria for a mental health disorder (i.e. SCID interview confirms diagnosis of DSM5 mental health disorder, he or she is randomized to receive the study ICT therapy or standard care (SC)
Research assessments are then also conducted at four months and seven months post baseline assessment. The follow-up assessments will consist of the same measures administered at baseline, with the exception of the SCID interview.
The investigators plan to randomize approximately 76 participants in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrating Combined Therapies | Experimental | Behavioral: Integrating Combined TherapiesIntegrating Combined Therapies (ICT) is a 10-session, manual-guided individual therapy. ICT has three phases designed to address substance use, psychiatric problems and their interactions. MET is the first phase (2 sessions) and is focused on assessment, feedback and securing motivation to address problems and take steps. CBT is the second phase (5 sessions) and incorporates patient education and functional analysis, develops coping skills, teaches methods to challenge beliefs, and activates alternative behaviors. TSF (3 sessions) is focused on maintaining recovery and engaging in community-based recovery activities. Although ICT has core components, its application is flexible to accommodate the unique needs and problems of individual patients (and their comorbidities). |
| Standard Care | Active comparator | Behavioral: Standard CareStandard Care (SC) is the typical outpatient treatment that the patient would receive ordinarily at the identified addiction treatment program. SC service operates using the American Society of Addiction Medicine criteria (9 hours per week); group and individual sessions focused on motivation to address substance use, education about the consequences of substance use on major life areas, education about the disease concept and brain changes associated with addiction, exposure to information about social and family relationships and recovery, and relapse prevention skills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years old;
- Evaluated and admitted to outpatient addiction treatment services at RMHS Evergreen program and meets criteria for any alcohol or substance use disorder;
- Screened positive for an alcohol problem on the Alcohol Use Disorders Identification Test (AUDIT) (score of 8 or higher) (screening instrument);
- Screened positive for a mental health problem on the Modified MINI Screen (MMS) (score of 6 or higher) (screening instrument);
- Diagnoses confirmed by SCID (diagnostic interview); AND
Key exclusion criteria (3 listed)
- They have acute psychotic symptoms and are not appropriately connected with mental health services;
- They have had a psychiatric hospitalization or suicide attempt within the past month (however, if the hospitalization or attempt was directly related to substance intoxication or detoxification and the person is currently stable, they are eligible); OR
- They have unstable medical or legal situations that would make participation for the full duration of the study highly unlikely.
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 |
|---|---|---|
| Integrating Combined TherapiesAlso: ICTIndividual Integrating Combined Therapies, approximately 10 sessions, one session per week | Behavioural | Integrating Combined Therapies |
| Standard CareAlso: SCStandard Care, individual or group therapy, approximately 9 hours per week for 3 months. | Behavioural | Standard Care |
Primary outcome
Decrease from baseline in alcohol use (90-day Timeline Follow Back (TLFB) at 4-months and at 7-months
Time frame: Baseline, 4-month, 7-month follow-up
Decrease from baseline in alcohol use severity (ASI; alcohol severity composite) at 4-months and at 7-months
Time frame: Baseline, 4-month, 7-month follow-up
Decrease from baseline in alcohol use severity (Short Inventory of Problems (SIP)) at 4-months and at 7-months
Time frame: Baseline, 4-month, 7-month follow-up
Decrease from baseline in psychiatric symptom severity (ASI; Psychiatric Severity Composite) at 4-months and at 7-months
Time frame: Baseline, 4-month, 7-month follow-up
Decrease in psychiatric symptom severity (Brief Symptom Inventory (BSI)) at 4-months and 7-months
Time frame: Baseline, 4-month, 7-month follow-up
3 secondary outcomes
Decrease from baseline in drug use (90-day TLFB) at 4-months and at 7-months
Time frame: Baseline, 4-month, 7-month follow-up
Decrease from baseline in positive toxicology screen (urine drug screen) at 4-months and at 7-months
Time frame: Baseline, 4-month, 7-month follow-up
Decrease from baseline in drug use severity (ASI; Drug Severity Composite) at 4-months and 7-months
Time frame: Baseline, 4-month, 7-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
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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.
Mark P. McGovern, Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrating Combined Therapies in people with Alcohol Use Disorder and Mental Health Disorder, run by Stanford University 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jun 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decrease from baseline in alcohol use (90-day Timeline Follow Back (TLFB) at 4-months and at 7-months (time frame: Baseline, 4-month, 7-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2018.