Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04400565
Other study ID # B-BR-107-044
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 26, 2019
Est. completion date July 21, 2020

Study information

Verified date July 2021
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recovery-oriented approach has been the main trend in mental health field. However, few recovery-oriented programs are available in Taiwan, and many Taiwanese people with mental illness don't understand the concepts of recovery. A program which provides recovery knowledge and assists in setting recovery goals is beneficial for Taiwanese people with mental illness. Hence, this study aimed to investigate the effectiveness of a recovery program for people with mental illness.


Description:

This is a randomized control trial. Participants will be recruited from the psychiatric rehabilitation organizations in Taiwan. They will be randomly assigned to the intervention group or control 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 five questionnaires during the recruitment meeting, including Stages of Recovery Scale, Medical Outcomes Study Social Support Survey, The Hope Scale, Rosenberg Self-Esteem Scale and Brief Symptom Rating Scale-50. 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. The control group will receive a spiritual book and complete the questionnaires at the same time as the intervention group.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date July 21, 2020
Est. primary completion date July 21, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - diagnosis of mental illness - lived in community Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Recovery group
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)

Locations

Country Name City State
Taiwan National Cheng Kung University Hospital Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative data 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. At 10 weeks, 20 weeks and 44 weeks
Primary Stages of Recovery Scale (SRS) 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. Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Secondary Medical Outcomes Study Social Support Survey (MOS-SS) 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). Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Secondary The Hope Scale (THS) 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). Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Secondary Rosenberg Self-Esteem Scale (RSE) 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. Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Secondary Brief Symptom Rating Scale-50 (BSRS-50) 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
See also
  Status Clinical Trial Phase
Completed NCT03291717 - Bridging Community Gaps Photovoice N/A
Completed NCT05078450 - Mood Lifters Online for Graduate Students and Young Professionals N/A
Completed NCT02990026 - Specialty Mental Health Probation in North Carolina N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Not yet recruiting NCT03249428 - E-Cigarette Inner City RCT N/A
Completed NCT00380536 - Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings N/A
Recruiting NCT03966872 - Comparative Effectiveness of IIMR Versus CDSMP N/A
Completed NCT03963245 - Project Meaningful Activities and Recovery N/A
Not yet recruiting NCT06078124 - Sibling-Support for Adolescent Girls (SSAGE) N/A
Completed NCT01430741 - MISSION-Vet HUD-VASH Implementation Study N/A
Recruiting NCT03302364 - A Research in Pharmacogenomics and Accurate Medication of Risperidone
Completed NCT03018951 - Assessing Frailty in Older Adults With Functional Mental Illness
Completed NCT00272168 - The Use of Skills Training to Augment CWT/VI for Veterans With SMI N/A
Completed NCT05467982 - Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions N/A
Completed NCT05128045 - Weight Management & Wellness for People With Psychiatric Disabilities N/A
Completed NCT01676909 - Wellness Self-Management N/A
Completed NCT02990000 - Enhancing Mental Health Care by Scientifically Matching Patients to Providers' Strengths N/A
Completed NCT00283270 - Effectiveness of Screening and Counselling for Elderly With Psychological Problems Phase 4
Recruiting NCT03218748 - Honest, Open, Proud for Soldiers With Mental Illness N/A
Recruiting NCT03748004 - IPS/Peer Support Intervention in the DTES N/A