Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy in Patients With Schizophrenia
Condition: Randomized Controlled Trial
MeSH terms: Rumination Syndrome; Schizophrenia
Study type: Interventional

Summary: 
      This study will explore the effect of Rumination-Focused Cognitive Behaviour Therapy on
      depressive symptoms in patients with schizophrenia for three months. A randomized controlled
      trial is conducted in a psychiatric center in northern Taiwan. All participants are
      randomized to two groups using blocked randomization. The experimental groups are provided
      with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks), while the
      control groups receive a 6- session Health Education program for 12 weeks (60-90 mins, once
      every two weeks). All participants who suffered from depressive symptoms at both baseline and
      3-month follow-up will be evaluated using the Beck Depression Inventory(BDI-II), Chinese
      Response Style Questionnaire-short form revised(CRSQ-10), Internalized Stigma of Mental
      Illness (ISMI) Scale, and Herth Hope Index Chinese Version(HHI).
    

Detailed description: 
      Background:

      Depressive symptoms are one of the core symptoms in patients with schizophrenia, but the
      effect of depressive symptoms on patients is easily overlooked. Severe depressive symptoms in
      patients with schizophrenia are not only affecting the quality of life but also the risk
      factors of suicide.

      Aim:

      The investigators hypothesize that Rumination-Focused Cognitive Behaviour Therapy(RFCBT)
      could have significant effect of depressive symptoms. Therefore, in this study, the
      investigators will explore the effect of Rumination-Focused Cognitive Behaviour
      Therapy(RFCBT) on depressive symptoms in patients with schizophrenia.

      Methods:

      The study is conducted as a two-arm, single-blinded, randomized controlled trial in a
      psychiatric center in northern Taiwan. Participants are randomly allocated in a 1:1 ratio to
      two groups using blocked randomization. The experimental groups are provided with a 6-
      session RFCBT program for 12 weeks (60-90 mins, once every two weeks), while the control
      groups receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two
      weeks) .

      Participants and demographic data:

      Participants who have been diagnosed with schizophrenia according to DSM-IV criteria took
      part in the study after informed consent is obtained. All participants are 20 years of age or
      older and are receiving a stable dosage of antipsychotics, and have no history of cognitive
      impairment. The participants are able to express themselves and to individually complete the
      Beck Depression Inventory(BDI-II), Chinese Response Style Questionnaire-short form
      revised(CRSQ-10), Internalized Stigma of Mental Illness (ISMI) Scale, and Herth Hope Index
      Chinese Version(HHI).

      Measures:

      The demographic characteristics include five continuous variables (age, age at onset,
      duration of disease, years of education, chlorpromazine equivalent dose (Andreasen, Pressler,
      Nopoulos, Miller, & Ho, 2010) and four categorical variables (sex, marital status, work
      status, antidepressants).

      Procedure and Data collection:

      All procedures are approved by both national Ying Ming university(IRB YM108038F) and the
      psychiatric center (IRB 1080009-01). Following informed consent, each participant will fill
      out a demographic questionnaire and complete the BDI-II, CRHQ-10, ISMIS, and HHI once at
      baseline and twice an interval of three months. A well-trained and licensed psychiatric nurse
      will perform the data collection and assists the participants if there were difficulties
      reading or understanding the questionnaires.

      Statistical analysis:

      This study will employ Predictive Analytics Suite Workstation (IBM SPSS 24.0) to analyze the
      collected data. The data analyses will include demographic variables and the scores of
      BDI-II, CRHQ-10, ISMIS, and HHI at the interval of three months of all of the participants.
    

Intervention name(s): Rumination-Focused Cognitive Behaviour Therapy; Health Education programme
Intervention type(s): Behavioral; Other
Intervention description(s): Rumination-Focused Cognitive Behavioural Therapy(RFCBT) is based on a differentiation between functional and dysfunctional styles of perseverative thinking with the helpful style characterized as a concrete, process-focused and specific style of thinking and the idea that rumination is a habit maintained by negative reinforcement. In line with the theoretical assumptions, RFCBT combines strategies from behavioral activation with strategies to foster concrete, process-focused and specific thinking.; Health education programme would be any planned activity or set of activities aimed at increasing health literacy and developing life skills conducing to health (e.g. decision making, problem solving, critical thinking, interpersonal skills, stress management, coping with emotions).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were divided into experimental and control groups through block randomization
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Rumination-Focused Cognitive Behaviour Therapy(RFCBT); depressive symptom; Schizophrenia