Intervention to Improve Coping With Negative Emotions in Patients With Psychosis (Feel-Good-Study)
Condition: Early Psychosis; Delusions; Emotional Distress; Self Esteem
MeSH terms: Psychotic Disorders; Mental Disorders; Delusions
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the present single-centered pre-post study is to assess the feasibility and to
      investigate the putative efficacy of an emotion-oriented group intervention for patients with
      psychosis. Patients with early psychosis in an inpatient unit receive a manualized group
      intervention focussing on emotional stability and emotion regulation (8 weekly sessions).
      Assessment will be performed at pre-therapy, post-therapy (after eight sessions and four
      weeks) and after a follow-up period of 12 weeks (8 weeks post therapy) and includes personal
      therapy goals and their realization, psychopathology, social functioning and emotion
      regulation skills as a putative mediator of change.
    

Detailed description: 
      The aim of the present single-centered pre-post study is to assess the feasibility and to
      investigate the putative efficacy of an emotion-oriented cognitive-behavioral group
      intervention for patients with psychosis.

      Patients with psychosis in an inpatient unit are informed on the study and written consent is
      obtained. At start of therapy, psychopathological interviews and self-report questionnaires
      are performed. Participants are reassessed after the intervention of 8 sessions
      (approximately 8 weeks) and after a follow-up period of 8 additional weeks).

      Patients are enrolled in a manualized group therapy over 8 sessions including 7 modules. In
      the first session, group rules are obtained and individual therapy goals are elaborated and
      developed for each patient. In the next seven sessions, in each session a new module is
      presented to the patient and the skills are trained in training sessions and role plays.

      Module 1 informs on emotions and their role in mental health, module 2 informs on
      techniques/skills in order to cope with negative emotions more generally. In module 3,
      mindfulness is presented as a technique to reduce the impact of negative emotions on the
      patients' life and practised. In module 4, patients learn skills on how to reduce their
      vulnerability for negative emotions in general. In Module 5, patients learn skills on how to
      cope with anger, Module 6 teaches skills on how to cope with guilt and shame, Module 7 is
      presented in the last session and includes skills on how to improve general emotional
      stability and to prevent relapse.

      Training: Therapists are psychologists or psychiatrists that are currently in postgraduate
      training of Cognitive Behavior Therapy and received 8 sessions of additional training by the
      study PI.

      Primary outcome variables are attainment of the individual therapy goals of the patient (Goal
      Attainment Scale) and reduced general psychopathology (PANSS total score) after 8 sessions
      therapy. Secondary outcomes are depressive symptoms (Calgary Depression Scale for
      Schizophrenia), social functioning (Role functioning scale), self-reported delusions (Peters
      et al. delusions inventory), self-reported persecutory delusions (Paranoia checklist),
      emotion regulation skills (Emotion Regulation Skills Questionnaire, Emotion regulation
      questionnaire, Emotion Regulation Inventory), self-esteem (Rosenberg Self-esteem
      Questionnaire) and the Beliefs About Stress Scale (BASS). Furthermore, patients are asked to
      assess feasibility and acceptance of the group intervention. Emotion regulation skills and
      self-esteem are also tested as putative mediators of change.
    

Intervention name(s): Feel-Good- Group
Intervention type(s): Behavioral
Intervention description(s): Eight sessions of group intervention focussing on information on emotion regulation, training of emotion regulation techniques and mindfulness.
Other intervention name(s): Emotion-oriented version of Cognitive Behavior Therapy for psychosis in group format for inpatients with psychosis
Intervention model: Single Group Assignment
Intervention model description: A single group of patients will be enrolled in the study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychosis; Cognitive behavioral therapy; Group therapy; targeted therapy; emotion regulation; emotional stability