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The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study

Primary Purpose

Mental Illness

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Recovery program
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Illness

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of mental illness
  • lived in community

Exclusion Criteria:

-

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Recovery group

Control group

Arm Description

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.

The control group will receive a spiritual book and complete the questionnaires at the same time as the recovery group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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.
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).

Full Information

First Posted
June 16, 2020
Last Updated
October 17, 2022
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04437186
Brief Title
The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study
Official Title
The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovery group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive a spiritual book and complete the questionnaires at the same time as the recovery group.
Intervention Type
Behavioral
Intervention Name(s)
Recovery program
Intervention Description
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)
Primary Outcome Measure Information:
Title
Stages of Recovery Scale (SRS)
Description
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.
Time Frame
Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Secondary Outcome Measure Information:
Title
Medical Outcomes Study Social Support Survey (MOS-SS)
Description
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).
Time Frame
Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Title
The Hope Scale (THS)
Description
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).
Time Frame
Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Title
Rosenberg Self-Esteem Scale (RSE)
Description
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.
Time Frame
Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Title
Brief Symptom Rating Scale-50 (BSRS-50)
Description
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).
Time Frame
Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Other Pre-specified Outcome Measures:
Title
Qualitative data
Description
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.
Time Frame
At 10 weeks, 20 weeks and 44 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of mental illness lived in community Exclusion Criteria: -
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

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The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study

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