NCT04442893

Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy in Patients With Schizophrenia

Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy on Depressive Symptoms in Patients With Schizophrenia: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: National Yang Ming Chiao Tung University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Randomized Controlled Trial

Interventions

Type	Name	Description
BEHAVIORAL	Rumination-Focused Cognitive Behaviour Therapy	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.
OTHER	Health Education programme	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).

Timeline

• Start date: 2019-07-22
• Primary completion: 2019-08-18
• Completion: 2020-03-16
• First posted: 2020-06-23
• Last updated: 2023-11-09
• Results posted: 2023-11-09

Locations

1 site across 1 country: Taiwan