Chatbot Intervention for Anxiety and Depressive Symptoms in Young Adults
Condition: Anxiety; Depression
MeSH terms: Depression; Anxiety Disorders
Study type: Interventional

Summary: 
      This clinical trial compares the effects of using an artificial intelligence based therapy
      chatbot and a self-help book to lower anxiety and depressive symptoms. The therapy chatbot
      (named Fido) is an application delivering support for mental health via a conversation-like
      interface in a highly inflected language (Polish).

      The team will recruit young people (aged 18-35) who currently struggle with anxiety and/or
      depression. The participants will use the chatbot or self-help materials for two weeks. Then,
      the researchers will check if using the chatbot or the book improved several aspects of
      mental health and the quality of life. Moreover, they will compare the groups for any
      differences in outcomes.
    

Detailed description: 
      The primary objective of this randomized controlled trial is to evaluate the effectiveness of
      a chatbot-delivered cognitive-behavioural intervention on anxiety and depressive symptoms
      (and their correlates, such as quality of life or feelings of loneliness) in a subclinical
      sample of about 80 participants.

      The intervention results are compared to an active control intervention with popular
      self-help materials. Secondary objectives include the assessment and analysis of the
      human-chatbot therapeutic bond and general user experience.

      The study uses a 2 x 3 mixed factorial design with two intervention arms (Fido chatbot vs
      self-help book) and three time points (T1: just prior to the intervention, T2: immediately
      after the intervention, T3: at a follow-up one month after the previous measurement). The
      primary intervention lasts two weeks.

      All primary and secondary outcomes are assessed using self-administered online questionnaires
      in Polish. Each primary outcome measure is analyzed using a 2 (arms) x 2 (time points) ANOVA
      models with T1-T2 comparisons to test for the intervention effect and T1-T3 comparisons to
      check the stability of the intervention effect. Additional analyzes utilize standard NHST
      calculations and procedures (such as t-tests and correlation coefficients) alongside the
      conventional ⍺=.05 level.

      Similarly to the previous research in this area, no blinding is used. Participants are
      informed about different conditions, but the research hypotheses are masked.
    

Intervention name(s): Chatbot; Control (book)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in this condition were asked to use Fido, a Polish therapy chatbot, for two weeks. No minimal requirements of usage time were enforced, but participants had to fill in five engagement check surveys during the intervention period. Each survey had to be completed in less than 24 hours.; Participants in this condition were told to read selected chapters from a self-help book during the two-week intervention period. No minimal requirements of usage time were enforced, but participants had to fill in five engagement check surveys during the intervention period. Each survey had to be completed in less than 24 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anxiety; depression; quality of life; loneliness