- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04400565
The Effectiveness of a Recovery Program for People With Mental Illness.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tainan, Taiwan
- National Cheng Kung University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosis of mental illness
- lived in community
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Recovery group
The recovery program has 2 phases and consists of 20 classes, 1.5 hour per class and one class per week.
We will introduce concepts of recovery and personal strengths in phase 1.
Then, we will help participants to set goals and implement their plans in phase 2. Participants will fill out all questionnaires during the recruitment meeting.They will fill out the same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. Six months later, participants will receive a follow-up interview and fill out the questionnaires again.
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The researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the Pathways to Recovery (PTR): A Strengths Recovery Self-Help Workbook (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001)
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No Intervention: Control group
The control group will receive a spiritual book and complete the questionnaires at the same time as the recovery group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stages of Recovery Scale (SRS)
Time Frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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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.
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Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medical Outcomes Study Social Support Survey (MOS-SS)
Time Frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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The Medical Outcomes Study Social Support Survey (MOS-SS) is a multidimensional, self-administered instrument that addresses all five functions of an interpersonal relationship to assess the various functional dimensions of social support, including emotional , informational, tangible, affectionate, and positive interaction (Sherbourne & Stewart, 1991).For each item, the respondents were asked to indicate how often each support was available to them if they needed it.
Response options were none of the time (1), a little of the time (2), some of the time (3), most of the time (4), and all of the time (5).
For each scale, simple algebraic sums were computed, and then the raw scale scores were transformed into a scale of 0 to 100.
The higher the score, the better the perception of social support.
The reliability and validity of the measure in an American population of adults with chronic illness have been established (Sherbourne & Stewart, 1991).
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Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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The Hope Scale (THS)
Time Frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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The THS is a self-report measure based on the principle that hope is a cognitive set based on an individual's agency (a sense of successful determination in being able to achieve one's goals and a perceived efficacy for initiating and sustaining action toward goal attainment) and pathways (an individual's cognitive appraisal of his or her ability to overcome obstacles and achieve these goals) (Synder et al., 1991).
The measure includes 12 items, four measuring pathways and four measuring agency, and four "filler" items that are not used for scoring.
The measure yields scores for the agency and pathways subscales, as well as a total score.
Across a number of different samples, alphas ranged from .64 to .80 for the pathways subscale, .71 to .77
for the agency subscale, and from .74 to .84 for the total score (Snyder et al., 1997).
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Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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Rosenberg Self-Esteem Scale (RSE)
Time Frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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The purpose of the 10 item RSE scale is to measure self-esteem.
As the RSE is a Guttman scale, scoring can be a little complicated.
Scoring involves a method of combined ratings.
Low self-esteem responses are "disagree" or "strongly disagree" on items 1, 3, 4, 7, 10, and "strongly agree" or "agree" on items 2, 5, 6, 8, 9. Two or three out of three correct responses to items 3, 7, and 9 are scored as one item.
One or two out of two correct responses for items 4 and 5 are considered as a single item; items 1,8, and 10 are scored as individual items; and combined correct responses (one or two out of two) to items 2 and 6 are considered to be a single item.
The scale can also be scored by totalling the individual 4 point items after reverse-scoring the negatively worded items.
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Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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Brief Symptom Rating Scale-50 (BSRS-50)
Time Frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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The BSRS comprises 50 items, which best reflect the original ten symptom dimensions and three indices of psychopathology from the SCL-90-R. It is self-rated by individuals on a 5-point scale of symptom severity distress (0-4). It can measure nine primary and one additional symptom dimension of psycho-pathology, as well as there indices of distress- General Severity Index (GSI), Positive Symptom Distress Index (PSDI), and Total Number of Positive Symptoms (PST) |
Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative data
Time Frame: At 10 weeks, 20 weeks and 44 weeks
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The course discussion of the end of phase 1 and phase 2 will be recorded.
In addition, the participants of the intervention group will be interviewed at follow up.
Those qualitative data will be transcribed and analyzed.
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At 10 weeks, 20 weeks and 44 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-BR-107-044
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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