Integrating Combined Therapies for Persons With Co-occurring Disorders

NCT02598518 | Completed DMC

• 1 other identifier: 1R21AA023001-01A1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder; Mental Health Disorder

Keywords

Integrating Combined Therapies; Alcohol Use Disorder; Mental Health Disorder

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Decrease in psychiatric symptom severity (Brief Symptom Inventory (BSI)) at 4-months and 7-months

  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

  Baseline, 4-month, 7-month follow-up

• Decrease from baseline in positive toxicology screen (urine drug screen) at 4-months and at 7-months

  Baseline, 4-month, 7-month follow-up

• Decrease from baseline in drug use severity (ASI; Drug Severity Composite) at 4-months and 7-months

  Baseline, 4-month, 7-month follow-up

Study Arms (2)

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).

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.

Behavioral: Standard Care

Interventions

Integrating Combined Therapies BEHAVIORAL

Individual Integrating Combined Therapies, approximately 10 sessions, one session per week

Also known as: ICT

Integrating Combined Therapies

Standard Care BEHAVIORAL

Standard Care, individual or group therapy, approximately 9 hours per week for 3 months.

Also known as: SC

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Evergreen - Rutland Mental Health

Rutland, Vermont, 05701, United States

Location

MeSH Terms

Conditions

Alcoholism; Mental Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mark P. McGovern, Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: November 6, 2015
• Study Start: July 1, 2015
• Primary Completion: September 30, 2017
• Study Completion: December 31, 2017
• Last Updated: June 29, 2018

Record last verified: 2018-06

Locations

US (1)