Randomized Controlled TrialNCT04442893
Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy in Patients With Schizophrenia
A study testing Rumination-Focused Cognitive Behaviour Therapy and Health Education programme in people with Randomized Controlled Trial, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Randomized Controlled Trial
- What is being tested?
- Rumination-Focused Cognitive Behaviour Therapy and Health Education programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jul 2019to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy on Depressive Symptoms in Patients With Schizophrenia: A Randomized Controlled Trial
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).
Read the 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
- Being tested
- Rumination-Focused Cognitive Behaviour Therapy, Health Education programme
- Keywords
- Rumination-Focused Cognitive Behaviour Therapy(RFCBT), depressive symptom, Schizophrenia
- Medical subject headings
- Depression, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rumination-Focused Cognitive Behaviour TherapyBehavioural
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 programmeOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks). Receives: Behavioral: Rumination-Focused Cognitive Behaviour Therapy |
| Control group | Other | The control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks) Receives: Other: Health Education programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
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.
Measured: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
Secondary outcomes (2)
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.
Measured: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
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.
Measured: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start22 Jul 2019
- Primary completion18 Aug 2019
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Randomized Controlled TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were divided into experimental and control groups through block randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Bali Psychiatric Center
- Responsible party
- Principal investigator, Chiu-Yueh Yang, National Yang Ming Chiao Tung University
- Investigators
- Chiu-Yueh Yang, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442893
- Sponsor's protocol ID
- YM108038F
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2019
- Last updated
- 9 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy on Depressive Symptoms in Patients With Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04442893
- Acronym / sponsor ID
- YM108038F
- Conditions
- Randomized Controlled Trial
- Keywords
- Rumination-Focused Cognitive Behaviour Therapy(RFCBT), depressive symptom, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Bali Psychiatric Center
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 18 Aug 2019 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Posted 9 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants were divided into experimental and control groups through block randomization
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Rumination-Focused Cognitive Behaviour TherapyThe experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks). |
| Control group | Other | Other: Health Education programmeThe control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rumination-Focused Cognitive Behaviour TherapyRumination-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. | Behavioural | Experimental group |
| Health Education programmeHealth 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). | Other | Control group |
Primary outcome
Beck Depression Inventory (BDI-II)
Time frame: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
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.
Chinese Response Style Questionnaire-short Form Revised (CRSQ-10)
Time frame: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
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.
2 secondary outcomes
The Internalized Stigma of Mental Illness (ISMI) Scale
Time frame: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
Herth Hope Index Chinese Version(HHI)
Time frame: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiu-Yueh Yang, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rumination-Focused Cognitive Behaviour Therapy and Health Education programme in people with Randomized Controlled Trial, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (BDI-II) (time frame: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.