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

NCT04442893 | Completed Results DMC

• 1 other identifier: YM108038F
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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).

Conditions

Randomized Controlled Trial

Keywords

Rumination-Focused Cognitive Behaviour Therapy(RFCBT); depressive symptom; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (2)

• The Internalized Stigma of Mental Illness (ISMI) Scale

  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)

  For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).

Study Arms (2)

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).

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)

Other: Health Education programme

Interventions

Rumination-Focused Cognitive Behaviour Therapy BEHAVIORAL

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.

Experimental group

Health Education programme OTHER

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).

Control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Bali Psychiatric Center: collaborator

Study Sites (1)

National Yang-Ming University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Depression; Schizophrenia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Chiu-Yueh Yang, Professor
• Organization: National Yang Ming University

cyyang3@ym.edu.tw

886-2-28267388

Study Officials

• Chiu-Yueh Yang, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The data of PANSS were collected by a research assistant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Nursing Department

Model Details: The participants were divided into experimental and control groups through block randomization

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: June 23, 2020
• Study Start: July 22, 2019
• Primary Completion: August 18, 2019
• Study Completion: March 16, 2020
• Last Updated: November 9, 2023
• Results First Posted: November 9, 2023

Record last verified: 2023-11

Locations

TW (1)