Chronic SchizophreniaNCT06206798
Resourcefulness Group Intervention on Recovery and Quality of Life
A study testing Resourcefulness Group in people with Chronic Schizophrenia and Quality of Life, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The purpose of this study was to test the effects of resourcefulness group intervention on facilitating recovery and improving the quality of life in patients with chronic schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Chronic Schizophrenia, Quality of Life, Recovery
- What is being tested?
- Resourcefulness Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jun 2022to 14 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who have been diagnosed with schizophrenia by a psychiatrist for more than two years and are currently receiving rehabilitation treatment in a chronic ward.
- Age between 20-64 years old.
- Those with stable conditions can communicate in Mandarin or Taiwanese.
Who cannot join
- Exclude clients with Intellectual Disabilities, Organic Encephalopathy, Substance-related and addictive disorders, Personality disorders, Dementia, Cancers, etc.
- Those who are unable to understand the contents of the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Resourcefulness Group Intervention on Recovery and Quality of Life in Patients With Chronic Schizophrenia.
The purpose of this study was to test the effects of resourcefulness group intervention on facilitating recovery and improving the quality of life in patients with chronic schizophrenia.
Read the detailed description
Purpose: This study aimed to explore the effects of resourcefulness group intervention on facilitating recovery and improving the quality of life in patients with chronic schizophrenia.
Methods: A longitudinal and interventional study with a quasi-experimental research design and convenience sampling were used in this study. Patients with chronic schizophrenia from a psychiatric hospital in northern Taiwan were recruited as subjects and were divided under random assignment into the experimental group and the control group with twenty participants in each. The twenty participants in the experiment group were further randomly distributed into two groups. Both received resourcefulness group intervention weekly for six weeks, while the control group followed regular care routines and underwent conventional treatment. All participants took a pretest before the intervention, the first posttest after six rounds of intervention, and the second posttest four weeks after the group intervention was completed. Data were collected using structured questionnaires, including the Chinese version of the Resourcefulness Scale (C-RS), the Chinese Questionnaire about the Process of Recovery (QPR), the WHOQOL-BREF Taiwan Version, and other personal information.
- Conditions
- Chronic Schizophrenia, Quality of Life, Recovery
- Being tested
- Resourcefulness Group
- Keywords
- Resourcefulness, Chronic Schizophrenia, Resourcefulness Group, Recovery, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resourcefulness GroupBehavioural
The content of the Resourcefulness intervention group includes 6 sessions such as session 1 to introduce resourcefulness skills; sessions 2-4 to discuss personal resourcefulness skills including planning daily activities, and positive self-talk; sessions 4-5 to discuss social resourcefulness skills including relying on family or friends, and seeking professional assistance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 1. Subjects were randomly assigned to the experimental or the control group.
2. There were 20 members in the experimental group who received 6-week intervention activities.
3. Each subject was asked to fill out the questionnaires three times in total. The first time was before the intervention; the second time was right after the intervention; and the last time was four weeks later of the intervention. Receives: Behavioral: Resourcefulness Group |
| control group | No intervention | 1. There were 20 members in the control group who accepted chronic nursing care as usual without any nursing intervention. 2. Each subject was asked to fill out the questionnaires three times in total. The first time was the same time as the experimental group; the second time was 6 weeks after the first test; and the last time was four weeks after the second test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of Resourcefulness Scale
Resourcefulness
Measured: Up to 10 weeks. The pre-test questionnaire will be completed before the group starts, the first post-test will be administered after the group, and the second post-test will be administered 4 weeks after the group ends
Chinese questionnaire about the process of recovery
recovery
Measured: Up to 10 weeks. The pre-test questionnaire will be completed before the group starts, the first post-test will be administered after the group, and the second post-test will be administered 4 weeks after the group ends
WHOQOL-BREF Taiwan version
Quality of Life
Measured: Up to 10 weeks. The pre-test questionnaire will be completed before the group starts, the first post-test will be administered after the group, and the second post-test will be administered 4 weeks after the group ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start6 Jun 2022
- Primary completion14 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SchizophreniaStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huaining Kao, National Taipei University of Nursing and Health Sciences
- Investigators
- Chien Yu Lai, PhD., Study director, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206798
- Sponsor's protocol ID
- C110142
- Status last verified
- Jan 2024
- First submitted
- 9 Aug 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resourcefulness Group Intervention on Recovery and Quality of Life in Patients With Chronic Schizophrenia.
- ClinicalTrials.gov ID
- NCT06206798
- Acronym / sponsor ID
- C110142
- Conditions
- Chronic Schizophrenia, Quality of Life, Recovery
- Keywords
- Resourcefulness, Chronic Schizophrenia, Resourcefulness Group, Recovery, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to test the effects of resourcefulness group intervention on facilitating recovery and improving the quality of life in patients with chronic schizophrenia.
Detailed description
Purpose: This study aimed to explore the effects of resourcefulness group intervention on facilitating recovery and improving the quality of life in patients with chronic schizophrenia.
Methods: A longitudinal and interventional study with a quasi-experimental research design and convenience sampling were used in this study. Patients with chronic schizophrenia from a psychiatric hospital in northern Taiwan were recruited as subjects and were divided under random assignment into the experimental group and the control group with twenty participants in each. The twenty participants in the experiment group were further randomly distributed into two groups. Both received resourcefulness group intervention weekly for six weeks, while the control group followed regular care routines and underwent conventional treatment. All participants took a pretest before the intervention, the first posttest after six rounds of intervention, and the second posttest four weeks after the group intervention was completed. Data were collected using structured questionnaires, including the Chinese version of the Resourcefulness Scale (C-RS), the Chinese Questionnaire about the Process of Recovery (QPR), the WHOQOL-BREF Taiwan Version, and other personal information.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Resourcefulness Group1. Subjects were randomly assigned to the experimental or the control group. 2. There were 20 members in the experimental group who received 6-week intervention activities. 3. Each subject was asked to fill out the questionnaires three times in total. The first time was before the intervention; the second time was right after the intervention; and the last time was four weeks later of the intervention. |
| control group | No intervention | –1. There were 20 members in the control group who accepted chronic nursing care as usual without any nursing intervention. 2. Each subject was asked to fill out the questionnaires three times in total. The first time was the same time as the experimental group; the second time was 6 weeks after the first test; and the last time was four weeks after the second test. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects who have been diagnosed with schizophrenia by a psychiatrist for more than two years and are currently receiving rehabilitation treatment in a chronic ward.
- Age between 20-64 years old.
- Those with stable conditions can communicate in Mandarin or Taiwanese.
Key exclusion criteria (2 listed)
- Exclude clients with Intellectual Disabilities, Organic Encephalopathy, Substance-related and addictive disorders, Personality disorders, Dementia, Cancers, etc.
- Those who are unable to understand the contents of the consent form.
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 |
|---|---|---|
| Resourcefulness GroupThe content of the Resourcefulness intervention group includes 6 sessions such as session 1 to introduce resourcefulness skills; sessions 2-4 to discuss personal resourcefulness skills including planning daily activities, and positive self-talk; sessions 4-5 to discuss social resourcefulness skills including relying on family or friends, and seeking professional assistance. | Behavioural | experimental group |
Primary outcome
Chinese version of Resourcefulness Scale
Time frame: Up to 10 weeks. The pre-test questionnaire will be completed before the group starts, the first post-test will be administered after the group, and the second post-test will be administered 4 weeks after the group ends
Resourcefulness
Chinese questionnaire about the process of recovery
Time frame: Up to 10 weeks. The pre-test questionnaire will be completed before the group starts, the first post-test will be administered after the group, and the second post-test will be administered 4 weeks after the group ends
recovery
WHOQOL-BREF Taiwan version
Time frame: Up to 10 weeks. The pre-test questionnaire will be completed before the group starts, the first post-test will be administered after the group, and the second post-test will be administered 4 weeks after the group ends
Quality of Life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Chien Yu Lai, PhD. study director
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resourcefulness Group in people with Chronic Schizophrenia and Quality of Life, run by National Taipei University of Nursing and Health Sciences 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 3 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 16 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chinese version of Resourcefulness Scale (time frame: Up to 10 weeks. The pre-test questionnaire will be completed before the group starts, the first post-test will be administered after the group, and the second post-test will be administered 4 weeks after the group ends). The study lists 3 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 16 Jan 2024.