A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults
Condition: LGBTQ; Sexual Behavior
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study is to test the efficacy of an online CBT intervention (EQuIP) that addresses the
      pathways through which minority stress compromises LGBTQ young adults' co-occurring mental
      (e.g., depression) and behavioral (e.g., substance use, condomless anal sex) health problems.
      This purpose of this study is to determine if the treatment is efficacious when delivered
      online and if its efficacy exceeds that of the self-monitoring control.
    

Detailed description: 
      To evaluate the preliminary efficacy of an LGBTQ-affirmative online CBT treatment and whether
      such an LGBTQ-affirmative focus adds benefit, a 2-arm RCT that would examine (1) whether
      online EQuIP demonstrates significant mental health improvements compared to self-monitoring
      of stress and mood, and (2) whether participant baseline LGBTQ-specific stress exposure
      moderates treatment efficacy, such that participants with the most LGBTQ-specific stress
      exposure benefit more from online EQuIP than self-monitoring of stress and mood.

      The primary outcomes are depressive symptoms, anxiety symptoms, substance abuse, sexual risk
      behavior, and suicidality, all of which disproportionally affect LGBTQ young adults.
      Secondary outcomes include hypothesized cognitive, affective, and behavioral minority stress
      mechanisms, such as internalized homophobia, rejection sensitivity, concealment, social
      isolation, and emotional dysregulation.

      Participants will be randomized to either self-monitoring control or Online EQuIP group.

      Self-monitoring control: In this control condition, participants will be asked to indicate
      their past 7-day mood; stress experiences; and mental and behavioral health on an online
      survey. This type of self-monitoring has been shown to yield improvement in behavioral health
      outcomes. Self-reporting LGBTQ stress experiences has also been shown to produce reductions
      in depression symptoms over time. Participants will record these experiences once per week
      for 10 weeks.

      Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will
      complete over the course of 10 weeks. Modules contain weekly psychoeducational text and
      vignettes about minority stress and mental health; brief videos illustrating the CBT skills;
      and homework exercises that therapists review and provide feedback on. Homework exercises
      include weekly tracking of stressful situations and mood, practicing new skills (e.g.,
      mindfulness, cognitive restructuring), and exercises related to considering the origins of
      stress and negative emotions that participants may be experiencing. Therapists provide
      feedback after each homework assignment, including reviewing each participant's treatment
      goals as part of the first session's homework. Therapists who support this condition will be
      instructed to incorporate LGBTQ-specific content and feedback into homework reviews.
      Therapists will either be postdoctoral fellows in the Pachankis lab or clinical/counseling
      psychology interns/externs in the Pachankis lab who possess an advanced degree in a mental
      health field with significant prior experience treating LGBTQ young adults with mental health
      concerns. Modules were adapted directly from the in-person materials (e.g., therapist manual,
      participant handouts) used in our previously successful trials of this treatment. A team of
      six therapists and supervisors of the original in-person treatment adapted the text for the
      online modules, including realistic vignettes and easy-to-follow skills training. A video
      production company created accompanying videos with our clinical team's close input.

      In preparation for this RCT, the online EQuIP treatment was delivered to 14 LGBTQ young
      adults who meet all eligibility criteria for the full trial. The purpose of this initial test
      was to ensure acceptability of the treatment content and usability of the technical platform.
    

Intervention name(s): Online EQuIP; Self-monitoring control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.; Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: on-line intervention