Clinical trial NCT02227589: Treatment for Teens With Alcohol Abuse and Depression
Official title: Treatment for Teens With Alcohol Abuse and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AOD Use, Abuse, and Dependence
Depression
Keywords: adolescent,
alcohol abuse
depression,
cognitive behavior therapy
cannabis abuse
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: UConn Health
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-08-28
Enrollment: 103
Sex: ALL
Minimum age (years): 13
Maximum age (years): 263
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will recruit adolescents with alcohol or cannabis abuse and clinically significant depression. All participants will receive 12 sessions of an evidence-based treatment for alcohol abuse, Motivation Enhancement Therapy/Cognitive Behavior Therapy-12, over 12 to 14 weeks. Those who are still depressed after 4 weeks will be randomized to receive treatment augmentation with either an integrated cognitive behavior therapy for depression, delivered by their study therapist, or depression treatment-as-usual in the community. The study hypothesis is that integrated depression treatment will surpass community treatment-as-usual in efficacy.

Detailed description: Alcohol and other substance use disorders (AOSUDs), primarily cannabis use disorders, continue to be a significant public health concern among American adolescents. AOSUDs are commonly accompanied by co-occurring psychiatric disorders including depression. This comorbidity has been associated with increased severity of AOSUD, earlier treatment termination, poorer outcomes, and increased suicidal risk. Presently there is neither a consensus nor a standard, evidence-based intervention to address the need for an effective and feasible treatment for both disorders. However, cognitive behavior therapy (CBT) has been found to be effective for each of these disorders, separately. In addition, in some, but not all, adolescents with both disorders, depression appears to respond rapidly to CBT that targets only alcohol or substance abuse. This suggests that early depression responders (EDRs) may not need additional treatment that targets depression directly, unlike their non-early responding (NEDR) counterparts. However, no studies have compared longer term outcomes of adolescent EDRs to NEDRs. Moreover, no randomized, controlled studies have tested the hypothesis that an integrated CBT intervention for co-occurring AOSUD and depression will be effective for both disorders, in NEDR adolescents.

In this two-site study, submitted in response to PA: PAS-10-251, we will recruit 170 eligible adolescents (102 at the University of Connecticut and 68 at Duke University), ages 13 years to 21 years-11 months, with alcohol or cannabis use disorders and clinically significant depression. All subjects will receive 12 sessions of Motivation Enhancement Therapy/Cognitive Behavior Therapy (MET/CBT-12), a standard, evidence-based intervention for alcohol or drug abuse over 12 to 14 weeks. After four weeks, NEDR adolescents will be randomized to depression treatment augmentation, either with seven sessions of CBT (CBT-D), integrated with MET/CBT-12, or with enhanced depression-treatment-as-usual in the community (D-ETAU). We estimate that 120 adolescents will be randomized; we will stratify randomization on gender, age, and presence/absence of a Major Depressive Episode. We will assess all 170 participants at baseline, weeks 4, 9, and 14 (after treatment), and at 3-, 6-, and 9-month follow-up.

The first aim of this study is to describe the percentage of depressed AOSUD adolescents who demonstrate EDR during alcohol or cannabis abuse treatment alone, examine EDR durability and EDR predictors. The second and third aims test the hypotheses that, for NEDR teens, an integrated treatment augmentation (CBT-D) will lead to better depression and alcohol or cannabis outcomes, respectively, than augmentation with D-ETAU. We will compare outcomes of all three groups (EDRs; and NEDRs in each augmentation), on alcohol use, depressive symptoms, alcohol- or cannabis-related functional impairment, maintenance of alcohol or cannabis treatment gains, and depression remission rates over time, and will analyze the temporal ordering of changes in alcohol or cannabis use and depression during and after treatment. This is the first study to test an adaptive treatment model with depressed alcohol or cannabis use disorder youths, and thus has significant potential to guide clinical practice.

Eligibility criteria: Inclusion Criteria:

* Age 13 years to 21 years, 11 months at baseline
* Current alcohol or cannabis abuse or dependence diagnosis (DSM-IV) OR current level of potentially harmful drinking or cannabis use as evidenced by (1) consumption of 4 or more drinks per drinking day (males) or three or more (females), or use of cannabis at least three times in past 90 days (or before admission into a controlled environment)
* Current clinically significant depression, defined as a score of 40 or more on the Children's Depression Rating Scale-Revised at baseline
* If currently taking anti-depressant medication, on a stable dose for at least one month
* Willingness to accept treatment
* Able to speak and read English (5th-grade level)
* Residence within 45-minute drive from treatment site
* Adolescent and a parent agree to sign Institutional Review Board approved consent/assent form; for subjects ages 18-19, parent involvement is optional and is the decision of the youth
* Parent/guardian agrees to provide collateral information and to designate two third parties who could be contacted in case the subject is lost to follow-up; for subjects ages 18-19, the participating youth will provide this information
* Participant (and parent, if youth is under age 18) not planning to move outside the area in the next 9 months.

Exclusion Criteria:

* Suicidal ideation with a plan, or suicide attempt within 30 days. In addition to such suicide risk being indicated in baseline interview material, a score exceeding the 89th percentile on the Suicide Ideation Questionnaire (SIQ-Jr), will necessitate an immediate risk assessment by the Independent Evaluator which may lead to exclusion under this criterion.
* Homicidal ideation with a plan or any plan to hurt others
* Lifetime diagnosis of psychosis, schizophrenia, bipolar disorder, intellectual disability or autistic disorder
* Current dependence on a substance other than alcohol, marijuana or nicotine
* Current non-alcohol or cannabis use disorder or depression primary diagnosis, i.e., the diagnosis requires care more urgently than does alcohol or cannabis use disorder or depression

Primary outcomes:
measure: Alcohol use frequency assessed with the Alcohol Consumption Questionnaire
timeFrame: Change from baseline to week 14; change from baseline to 9 months after treatment ends
measure: Severity of depression, as measured on the Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Change from baseline to week 4; Change from baseline to week 14; Change from baseline to 9 months after treatment ends
measure: Alcohol use quantity assessed with the Alcohol Consumption Questionnaire
timeFrame: Change from baseline to week 14; Change from baseline to 9 months after treatment ends
measure: Cannabis use frequency assessed with the Drug Checklist
timeFrame: Change from baseline to week 14; Change from baseline to 9 months after treatment ends
Secondary outcomes:
measure: Diagnosis
timeFrame: Baseline to Week 14; baseline to 9 Months after treatment ends
measure: Teen-Addiction Severity Index (T-ASI)
timeFrame: Baseline to Week 14; baseline to 9 months after treatment ends
measure: Suicidal Ideation Questionnaire-Jr. High Version (SIQ-Jr)
timeFrame: Baseline to Week 14; baseline to 9 months after treatment ends
measure: Children's Global Assessment of Functioning (CGAS)
timeFrame: Baseline to Week 14; baseline to 9 months after treatment ends
measure: Clinical Global Impression-Improvement in Depression (CGI-I)
timeFrame: Baseline to Week 14; baseline to 9 months after treatment ends
Other outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline to Week 14; baseline to 9 months after treatment ends
measure: Situational Confidence Questionnaire (SCQ)
timeFrame: Baseline to Week 14
measure: Urine analysis
timeFrame: From baseline through month 9 of follow-up
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John F Curry, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UConn Health
name: Yifrah Kaminer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curry JF, Kaminer Y, Goldston DB, Chan G, Wells KC, Burke RH, Inscoe AB, Meyer AE, Cheek SM. Adaptive Treatment for Youth With Substance Use and Depression: Early Depression Response and Short-term Outcomes. J Am Acad Child Adolesc Psychiatry. 2022 Apr;61(4):508-519. doi: 10.1016/j.jaac.2021.07.807. Epub 2021 Aug 6.