Mental IllnessNCT04075838
The Development and Efficacy of a Recovery Group for People With Mental Illness
A study testing Recovery group in people with Mental Illness, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Recovery-oriented approach has been promoted in psychiatric rehabilitation in recent years. This approach emphasizes that people with mental illness can live a hopeful life even though the symptoms still exist. However, few recovery-oriented programs are available in Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mental Illness
- What is being tested?
- Recovery group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Dec 2017to 12 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of mental illness
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Recovery-oriented approach has been promoted in psychiatric rehabilitation in recent years. This approach emphasizes that people with mental illness can live a hopeful life even though the symptoms still exist. However, few recovery-oriented programs are available in Taiwan. This study aimed to develop of a recovery-oriented program for people with mental illness and investigate its feasibility.
Read the detailed description
The study participants with mental illness were from a community mental health center in the south of Taiwan. The recovery-oriented program was conducted by a group leader, a senior occupational therapist, with one supervisor and one observer. The program was designed based on Pathways to Recovery, a self-help book published by University of Kansas. Participants attended a 1-hour class per week. The teaching methods included didactic presentation, peer exchange, group discussion, and practice. The group leader, supervisor, and observer reviewed the content and participants' performance after each class and made content adjustments if needed.
- Conditions
- Mental Illness
- Being tested
- Recovery group
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery groupOther
The researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the PTR (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001)
| Study group | Role | What they receive |
|---|---|---|
| Recovery group | Other | The researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the PTR (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001). The group gathered for a one-hour session once a week for 18 weeks. Receives: Other: Recovery group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of Recovery Scale：Change from Baseline at 10 weeks and 18 weeks
The scale consists of 45 items, with six subscales: the sense of hope, disability management/taking responsibility, regaining autonomy, social functioning/role performance, overall well-being, and willingness to help. It has good internal consistency and proper construct validity. The SRS utilizes a 4-point rating scale: never (0), seldom (1), sometimes (2), and often (3). Higher scores indicate better recovery. The developers also provide the cutoff scores for four recovery stages: Stage 1 (overwhelmed by the disability), 0-57; Stage 2 (struggling with disability), 58-90; Stage 3 (living with disability), 91-119; and Stage 4 (living beyond disability), 120-135.
Measured: baseline, 10 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start14 Dec 2017
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang Yen-Ching, Study chair, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075838
- Sponsor's protocol ID
- A-ER-106-245
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- 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 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Efficacy of a Recovery Group for People With Mental Illness
- ClinicalTrials.gov ID
- NCT04075838
- Acronym / sponsor ID
- A-ER-106-245
- Conditions
- Mental Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 3 Sep 2019 (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.
Recovery-oriented approach has been promoted in psychiatric rehabilitation in recent years. This approach emphasizes that people with mental illness can live a hopeful life even though the symptoms still exist. However, few recovery-oriented programs are available in Taiwan. This study aimed to develop of a recovery-oriented program for people with mental illness and investigate its feasibility.
Detailed description
The study participants with mental illness were from a community mental health center in the south of Taiwan. The recovery-oriented program was conducted by a group leader, a senior occupational therapist, with one supervisor and one observer. The program was designed based on Pathways to Recovery, a self-help book published by University of Kansas. Participants attended a 1-hour class per week. The teaching methods included didactic presentation, peer exchange, group discussion, and practice. The group leader, supervisor, and observer reviewed the content and participants' performance after each class and made content adjustments if needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recovery group | Other | Other: Recovery groupThe researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the PTR (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001). The group gathered for a one-hour session once a week for 18 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of mental illness
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Recovery groupThe researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the PTR (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001) | Other | Recovery group |
Primary outcome
Stages of Recovery Scale：Change from Baseline at 10 weeks and 18 weeks
Time frame: baseline, 10 weeks, 18 weeks
The scale consists of 45 items, with six subscales: the sense of hope, disability management/taking responsibility, regaining autonomy, social functioning/role performance, overall well-being, and willingness to help. It has good internal consistency and proper construct validity. The SRS utilizes a 4-point rating scale: never (0), seldom (1), sometimes (2), and often (3). Higher scores indicate better recovery. The developers also provide the cutoff scores for four recovery stages: Stage 1 (overwhelmed by the disability), 0-57; Stage 2 (struggling with disability), 58-90; Stage 3 (living with disability), 91-119; and Stage 4 (living beyond disability), 120-135.
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 3 Sep 2019.
- 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.
Chang Yen-Ching study chair
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery group in people with Mental Illness, run by National Cheng-Kung University Hospital 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 1 inclusion and 1 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 3 Sep 2019. 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?
Stages of Recovery Scale：Change from Baseline at 10 weeks and 18 weeks (time frame: baseline, 10 weeks, 18 weeks). 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 3 Sep 2019.