Clinical trial NCT04442893: Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy in Patients With Schizophrenia
Official title: Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy on Depressive Symptoms in Patients With Schizophrenia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Randomized Controlled Trial
Keywords: Rumination-Focused Cognitive Behaviour Therapy(RFCBT)
depressive symptom
Schizophrenia
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Bali Psychiatric Center
First posted: 2020-06-23
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were divided into experimental and control groups through block randomization
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* The participants are diagnosed with schizophrenia by Diagnostic and Statistical Manual of Mental Disorders, Five Edition (DSM-V), an age of between 20 and 65 years, hospitalization in a rehabilitation unit, and a stable condition at the time of data collection.
* The participants are able to provide written informed consent and comprehend the instruments.
* The participants consent to receive a 6- session RFCBT program or a 6- session Health Education program and complete a package of questionnaires.
* The participants are satisfied the screening criteria including the Positive and Negative Syndrome Scale (PANSS) for positive syndromes \< 5, the Mini-Mental State Examination (MMSE) ≥ 24, and the Brief Symptom Rating Scale (BSRS-5) ≥ 6.

Exclusion Criteria:

* The participants who have intellectual disturbances (organic mental disorders) or substance abuse issues through a chart review.
* The participants who are not willing to sign the consent.

Primary outcomes:
measure: Beck Depression Inventory (BDI-II)
timeFrame: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
measure: Chinese Response Style Questionnaire-short Form Revised (CRSQ-10)
timeFrame: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
Secondary outcomes:
measure: The Internalized Stigma of Mental Illness (ISMI) Scale
timeFrame: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
measure: Herth Hope Index Chinese Version(HHI)
timeFrame: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Chiu-Yueh Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: