Trial Outcomes & Findings for Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy in Patients With Schizophrenia (NCT NCT04442893)
NCT ID: NCT04442893
Last Updated: 2023-11-09
Results Overview
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.
COMPLETED
NA
85 participants
For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
2023-11-09
Participant Flow
Participant milestones
| Measure |
Experimental Group
The experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks).
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.
|
Control Group
The control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks)
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).
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
41
|
|
Overall Study
COMPLETED
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=44 Participants
The experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks).
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.
|
Control Group
n=41 Participants
The control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks)
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).
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Religious preference
None
|
5 Participants
n=44 Participants
|
8 Participants
n=41 Participants
|
13 Participants
n=85 Participants
|
|
Work status
Employed
|
11 Participants
n=44 Participants
|
15 Participants
n=41 Participants
|
26 Participants
n=85 Participants
|
|
Religious preference
Buddha/Christian/other
|
39 Participants
n=44 Participants
|
33 Participants
n=41 Participants
|
72 Participants
n=85 Participants
|
|
Work status
Not employed
|
33 Participants
n=44 Participants
|
26 Participants
n=41 Participants
|
59 Participants
n=85 Participants
|
|
Age, Continuous
|
51.18 years
STANDARD_DEVIATION 7.88 • n=44 Participants
|
51.24 years
STANDARD_DEVIATION 8.09 • n=41 Participants
|
51.21 years
STANDARD_DEVIATION 7.93 • n=85 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=44 Participants
|
22 Participants
n=41 Participants
|
43 Participants
n=85 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=44 Participants
|
19 Participants
n=41 Participants
|
42 Participants
n=85 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Duration of disease
|
29.05 years
STANDARD_DEVIATION 8.43 • n=44 Participants
|
26.73 years
STANDARD_DEVIATION 8.68 • n=41 Participants
|
27.93 years
STANDARD_DEVIATION 8.58 • n=85 Participants
|
|
CPZ equivalent doses
|
503.77 mg
STANDARD_DEVIATION 260.58 • n=44 Participants
|
471.29 mg
STANDARD_DEVIATION 286.56 • n=41 Participants
|
488.11 mg
STANDARD_DEVIATION 272.26 • n=85 Participants
|
|
Year of Education
|
11.68 years
STANDARD_DEVIATION 2.88 • n=44 Participants
|
11.39 years
STANDARD_DEVIATION 2.91 • n=41 Participants
|
11.54 years
STANDARD_DEVIATION 2.89 • n=85 Participants
|
|
Marital status
Single
|
36 Participants
n=44 Participants
|
35 Participants
n=41 Participants
|
71 Participants
n=85 Participants
|
|
Marital status
Married
|
8 Participants
n=44 Participants
|
6 Participants
n=41 Participants
|
14 Participants
n=85 Participants
|
|
Antidepressant users
No
|
39 Participants
n=44 Participants
|
34 Participants
n=41 Participants
|
73 Participants
n=85 Participants
|
|
Antidepressant users
Yes
|
5 Participants
n=44 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=85 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental Group
n=44 Participants
The experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks).
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.
|
Control Group
n=41 Participants
The control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks)
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).
|
|---|---|---|
|
Beck Depression Inventory (BDI-II)
T0
|
16.89 score on a scale
Standard Deviation 12.32
|
16.88 score on a scale
Standard Deviation 14.63
|
|
Beck Depression Inventory (BDI-II)
T1
|
16.60 score on a scale
Standard Deviation 10.80
|
18.70 score on a scale
Standard Deviation 12.88
|
|
Beck Depression Inventory (BDI-II)
T2
|
15.56 score on a scale
Standard Deviation 11.26
|
23.03 score on a scale
Standard Deviation 14.81
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental Group
n=44 Participants
The experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks).
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.
|
Control Group
n=41 Participants
The control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks)
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).
|
|---|---|---|
|
Chinese Response Style Questionnaire-short Form Revised (CRSQ-10)
T2
|
27.38 score on a scale
Standard Deviation 5.64
|
25.33 score on a scale
Standard Deviation 5.01
|
|
Chinese Response Style Questionnaire-short Form Revised (CRSQ-10)
T0
|
26.25 score on a scale
Standard Deviation 6.75
|
26.51 score on a scale
Standard Deviation 6.62
|
|
Chinese Response Style Questionnaire-short Form Revised (CRSQ-10)
T1
|
26.46 score on a scale
Standard Deviation 5.77
|
26.68 score on a scale
Standard Deviation 5.44
|
SECONDARY outcome
Timeframe: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).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.
Outcome measures
| Measure |
Experimental Group
n=44 Participants
The experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks).
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.
|
Control Group
n=41 Participants
The control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks)
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).
|
|---|---|---|
|
The Internalized Stigma of Mental Illness (ISMI) Scale
T0
|
71.86 score on a scale
Standard Deviation 11.33
|
68.63 score on a scale
Standard Deviation 11.53
|
|
The Internalized Stigma of Mental Illness (ISMI) Scale
T1
|
71.52 score on a scale
Standard Deviation 12.43
|
70.35 score on a scale
Standard Deviation 10.29
|
|
The Internalized Stigma of Mental Illness (ISMI) Scale
T2
|
69.12 score on a scale
Standard Deviation 12.83
|
70.44 score on a scale
Standard Deviation 10.08
|
SECONDARY outcome
Timeframe: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).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.
Outcome measures
| Measure |
Experimental Group
n=44 Participants
The experimental group would be provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks).
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.
|
Control Group
n=41 Participants
The control group would receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks)
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).
|
|---|---|---|
|
Herth Hope Index Chinese Version(HHI)
T0
|
33.86 score on a scale
Standard Deviation 6.23
|
33.54 score on a scale
Standard Deviation 4.35
|
|
Herth Hope Index Chinese Version(HHI)
T1
|
35.00 score on a scale
Standard Deviation 6.35
|
32.62 score on a scale
Standard Deviation 6.09
|
|
Herth Hope Index Chinese Version(HHI)
T2
|
34.71 score on a scale
Standard Deviation 6.62
|
32.17 score on a scale
Standard Deviation 6.81
|
Adverse Events
Experimental Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chiu-Yueh Yang, Professor
National Yang Ming University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place