N/A N=85 Randomized Single-blind Supportive Care

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

Randomized Controlled Trial

Bottom Line

View on ClinicalTrials.gov: NCT04442893 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Beck Depression Inventory (BDI-II) — 16.89; 16.88; 16.60; 18.70 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Rumination-Focused Cognitive Behaviour Therapy (Behavioral); Health Education programme (Other)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: National Yang Ming Chiao Tung University
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Beck Depression Inventory (BDI-II)	16.89; 16.88; 16.60; 18.70; 15.56; 23.03	—
PRIMARY Chinese Response Style Questionnaire-short Form Revised (CRSQ-10)	26.25; 26.51; 26.46; 26.68; 27.38; 25.33	—
SECONDARY The Internalized Stigma of Mental Illness (ISMI) Scale	71.86; 68.63; 71.52; 70.35; 69.12; 70.44	—
SECONDARY Herth Hope Index Chinese Version(HHI)	33.86; 33.54; 35.00; 32.62; 34.71; 32.17	—

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04442893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.