Integrating Combined Therapies for Persons With Co-occurring Disorders

Alcohol Use Disorder Clinical Trial

— ICT  

Official title:

Integrating Combined Therapies for Persons With Co-occurring Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598518
• Other study ID #: 1R21AA023001-01A1
• Secondary ID: 1R21AA023001-01A
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 31, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years old;

2. Evaluated and admitted to outpatient addiction treatment services at RMHS Evergreen program and meets criteria for any alcohol or substance use disorder;

3. Screened positive for an alcohol problem on the Alcohol Use Disorders Identification Test (AUDIT) (score of 8 or higher) (screening instrument);

4. Screened positive for a mental health problem on the Modified MINI Screen (MMS) (score of 6 or higher) (screening instrument);

5. Diagnoses confirmed by SCID (diagnostic interview); AND

6. Willing and able to provide informed consent.

Exclusion Criteria:

1. They have acute psychotic symptoms and are not appropriately connected with mental health services;

2. 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

3. They have unstable medical or legal situations that would make participation for the full duration of the study highly unlikely.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Disease
• Mental Disorders
• Mental Health Disorder

Intervention

Behavioral:
• Integrating Combined Therapies
Individual Integrating Combined Therapies, approximately 10 sessions, one session per week
• Standard Care
Standard Care, individual or group therapy, approximately 9 hours per week for 3 months.

Locations

Country	Name	City	State
United States	Evergreen - Rutland Mental Health	Rutland	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease from baseline in alcohol use (90-day Timeline Follow Back (TLFB) at 4-months and at 7-months		Baseline, 4-month, 7-month follow-up
Primary	Decrease from baseline in alcohol use severity (ASI; alcohol severity composite) at 4-months and at 7-months		Baseline, 4-month, 7-month follow-up
Primary	Decrease from baseline in alcohol use severity (Short Inventory of Problems (SIP)) at 4-months and at 7-months		Baseline, 4-month, 7-month follow-up
Primary	Decrease from baseline in psychiatric symptom severity (ASI; Psychiatric Severity Composite) at 4-months and at 7-months		Baseline, 4-month, 7-month follow-up
Primary	Decrease in psychiatric symptom severity (Brief Symptom Inventory (BSI)) at 4-months and 7-months		Baseline, 4-month, 7-month follow-up
Secondary	Decrease from baseline in drug use (90-day TLFB) at 4-months and at 7-months		Baseline, 4-month, 7-month follow-up
Secondary	Decrease from baseline in positive toxicology screen (urine drug screen) at 4-months and at 7-months		Baseline, 4-month, 7-month follow-up
Secondary	Decrease from baseline in drug use severity (ASI; Drug Severity Composite) at 4-months and 7-months		Baseline, 4-month, 7-month follow-up