MBCT and CBT for Youth at High Risk for Mood and Psychotic Disorders: a Randomized Controlled Trial
Condition: Mood Disorders; Prodromal Symptoms; Bipolar Disorder; Parents; Clinical High Risk
MeSH terms: Prodromal Symptoms; Bipolar Disorder; Mental Disorders; Psychotic Disorders; Mood Disorders
Study type: Interventional

Summary: 
      The present study is a randomized controlled trial comparing the efficacy and acceptability
      of CBT and MBCT group-based interventions adapted for young people at elevated risk for mood
      or psychotic disorder onset or relapse. Young people (ages 13-24) are provided with targeted
      psychoeducation and learn a variety of coping skills and wellness practices for mood
      regulation and stress and distress management. Parents meet separately to learn the same
      skills and receive guidance in supporting their youth with skill development. The therapy is
      also augmented by a mobile phone application that supports regular symptom monitoring and
      skills practice.
    

Detailed description: 
      Psychosocial interventions that improve emotional health and stability could have a
      dramatically favorable impact on individual suffering among adolescents and young adults at
      risk for severe mental illness, as well as their family members. Unfortunately, youth who are
      at risk for bipolar disorder or psychosis are treated with a wide variety of medications and
      therapies, with little evidence-based practice.

      The main objective of this study is to investigate the comparative efficacy and acceptability
      of weekly outpatient group-based Mindfulness based Cognitive Therapy (MBCT) and Cognitive
      Behavioral Therapy (CBT) adapted for youth at elevated risk for serious or persistent mood
      disorders or psychosis. Consistent with the National Institute of Mental Health's shift
      towards common underlying mechanisms across diagnoses ("Research Domain Criteria, or RDoc;
      Sanislow et al., 2010), recruitment for this study is transdiagnostic, targeting a range of
      youth with difficulties with mood dysregulation and stress.

      All randomized control trial (RCT) participants receive one of the two active treatments. The
      order of treatment groups has been randomized, with participants blinded to their treatment
      assignment. Five to 15 young participants of similar age (teen or young adult) comprise each
      group. Parents receive a parallel parent-only group that informs them of the content and
      skills presented to their offspring.

      The investigators will assess emotion dysregulation, psychiatric symptoms, overall
      functioning, and quality of life at baseline, immediately following the 9-week treatment, and
      at follow-up (3 months after therapy ends).

      Clinical symptoms, cognitions, mindfulness, emotion regulation, and well-being will be
      measured at baseline and each follow-up assessment. Both youth and young adults will
      participate in a follow-up assessment immediately after the intervention. Youth participants
      will participate in a second follow-up assessment 12 weeks post-treatment.

      The main investigative hypotheses are that both the MBCT and CBT programs will be acceptable
      to the young participants and parents and associated with high satisfaction ratings.
      Additionally, the investigators anticipate that both MBCT and CBT will be associated with
      comparable improvements in mood, anxiety, and psychotic symptoms and social functioning from
      pretreatment to final follow-up. Finally, the investigators anticipate that increases in
      mindfulness and reductions in negative cognitions from pretreatment to post-treatment and
      follow-up will be correlated with improvements in the young participants' self-reported
      emotional dysregulation and attention.

      The study aims to add to the body of knowledge on evidence-based interventions targeting mood
      and stress pathways for youth at risk for chronic or serious mental health challenges.
    

Intervention name(s): cognitive behavioral therapy; mindfulness-based cognitive therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 9 sessions of CBT weekly treatment in group setting; 9 sessions of MBCT weekly treatment in group setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: group therapy; psychotherapy; psychoeducation; skills training; mood disorders; prodromal psychosis; adolescents; parent group; youth