Randomized Controlled Trial Clinical Trial
Official title:
Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy on Depressive Symptoms in Patients With Schizophrenia: A Randomized Controlled Trial
NCT number | NCT04442893 |
Other study ID # | YM108038F |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 22, 2019 |
Est. completion date | March 16, 2020 |
Verified date | November 2023 |
Source | National Yang Ming University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 85 |
Est. completion date | March 16, 2020 |
Est. primary completion date | August 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Yang-Ming University | Taipei City |
Lead Sponsor | Collaborator |
---|---|
National Yang Ming University | Bali Psychiatric Center |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Beck Depression Inventory (BDI-II) | The Beck Depression Inventory-II (BDI-II) is a 21-item self-report depression screening measure. Each item is rated on a four-point Likert-type scale ranging from 0 to 3, which with possible scores ranging from 0 to 63. The BDI-II has been translated into a Chinese version. Higher total scores indicate more severe depressive symptoms, and a score of >16 points is considered suggestive of the presence of clinically significant depressive symptom intensity.
In this study, the investigators will explore the change of BDI-II score among baseline, after intervention and three-month follow-up. |
For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2). | |
Primary | Chinese Response Style Questionnaire-short Form Revised (CRSQ-10) | The Chinese Response Style Questionnaire-short form revised (CRSQ-10) is a self-report measure of rumination, comprising ten items and describing the factors of brooding and reflection. Each item is rated on a four-point Likert-type scale ranging from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 10 to 40. The CRSQ-10 has been used to evaluate the intensity of ruminative responses to depressed mood.
In this study, the investigators will explore the change of CRSQ-10 score among baseline, after intervention and three-month follow-up. |
For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2). | |
Secondary | The Internalized Stigma of Mental Illness (ISMI) Scale | The Internalized Stigma of Mental Illness (ISMI) Scale is a 29-item self-report questionnaire measuring self-stigma among persons with psychiatric disorders. Each item is rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 29 to 116. The ISMI Scale has been translated into a Chinese version. Higher scores indicating greater self-stigma.
In this study, the investigators will explore the change of ISMI Scale score among baseline, after intervention and three-month follow-up. |
For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2). | |
Secondary | Herth Hope Index Chinese Version(HHI) | The Herth Hope Index (HHI) comprises 12-item self-report measure of hopefulness. Each item is rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 12 to 48. The HHI has been translated into a Chinese version. Higher scores indicating greater hopefulness.
In this study, the investigators will explore the change of HHI score among baseline, after intervention and three-month follow-up. |
For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2). |
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