Treatment for Teens With Alcohol Abuse and Depression
Condition: AOD Use, Abuse, and Dependence; Depression
MeSH terms: Alcoholism; Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): MET/CBT-12; CBT-D; D-TAU
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Two sessions of motivation enhancement therapy followed by 10 sessions of cognitive behavior therapy targeting alcohol or cannabis abuse. These 12 sessions will be delivered over 12 to 14 weeks.; CBT-D consists of seven weekly sessions of cognitive behavior therapy targeting depression.; D-TAU is treatment as usual in the community, targeting depression. It may consist of medication and/or behavioral intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescent,; alcohol abuse; depression,; cognitive behavior therapy; cannabis abuse