<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04437186</url>
  </required_header>
  <id_info>
    <org_study_id>B-BR-108-064</org_study_id>
    <nct_id>NCT04437186</nct_id>
  </id_info>
  <brief_title>The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study</brief_title>
  <official_title>The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recovery-oriented approach has been the main trend in mental health field. However, few&#xD;
      recovery-oriented programs are available in Taiwan, and many Taiwanese people with mental&#xD;
      illness don't understand the concepts of recovery. A program which provides recovery&#xD;
      knowledge and assists in setting recovery goals is beneficial for Taiwanese people with&#xD;
      mental illness. Hence, this study aimed to investigate the effectiveness of a recovery&#xD;
      program for people with mental illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized control trial. Participants will be recruited from the psychiatric&#xD;
      rehabilitation organizations in Taiwan. They will be randomly assigned to the intervention&#xD;
      group or control group. The recovery program has 2 phases and consists of 20 classes, 1.5&#xD;
      hour per class and one class per week. We will introduce concepts of recovery and personal&#xD;
      strengths in phase 1. Then, we will help participants to set goals and implement their plans&#xD;
      in phase 2. Participants will fill out five questionnaires during the recruitment meeting,&#xD;
      including Stages of Recovery Scale, Medical Outcomes Study Social Support Survey, The Hope&#xD;
      Scale, Rosenberg Self-Esteem Scale and Brief Symptom Rating Scale-50. They will fill out the&#xD;
      same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. Six&#xD;
      months later, participants will receive a follow-up interview and fill out the questionnaires&#xD;
      again. The control group will receive a spiritual book and complete the questionnaires at the&#xD;
      same time as the intervention group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">October 1, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stages of Recovery Scale (SRS)</measure>
    <time_frame>Change from Baseline at 10 weeks, 20 weeks and 44 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Social Support Survey (MOS-SS)</measure>
    <time_frame>Change from Baseline at 10 weeks, 20 weeks and 44 weeks</time_frame>
    <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 &amp; 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 &amp; Stewart, 1991).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Hope Scale (THS)</measure>
    <time_frame>Change from Baseline at 10 weeks, 20 weeks and 44 weeks</time_frame>
    <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 &quot;filler&quot; 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rosenberg Self-Esteem Scale (RSE)</measure>
    <time_frame>Change from Baseline at 10 weeks, 20 weeks and 44 weeks</time_frame>
    <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 &quot;disagree&quot; or &quot;strongly disagree&quot; on items 1, 3, 4, 7, 10, and &quot;strongly agree&quot; or &quot;agree&quot; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Symptom Rating Scale-50 (BSRS-50)</measure>
    <time_frame>Change from Baseline at 10 weeks, 20 weeks and 44 weeks</time_frame>
    <description>The BSRS comprises 50 items, which best reflect the original ten symptom dimensions and three indices of psychopathology from the SCL-90-R.&#xD;
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).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Qualitative data</measure>
    <time_frame>At 10 weeks, 20 weeks and 44 weeks</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Mental Illness</condition>
  <arm_group>
    <arm_group_label>Recovery group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive a spiritual book and complete the questionnaires at the same time as the recovery group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Recovery program</intervention_name>
    <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)</description>
    <arm_group_label>Recovery group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of mental illness&#xD;
&#xD;
          -  lived in community&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04437186
org study id: B-BR-108-064
nct id: NCT04437186
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Stages of Recovery Scale (SRS)
time frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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.
measure: Medical Outcomes Study Social Support Survey (MOS-SS)
time frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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).
measure: The Hope Scale (THS)
time frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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).
measure: Rosenberg Self-Esteem Scale (RSE)
time frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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.
measure: Brief Symptom Rating Scale-50 (BSRS-50)
time frame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
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).
measure: Qualitative data
time frame: At 10 weeks, 20 weeks and 44 weeks
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.
arm group label: Recovery group
arm group type: Experimental
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 group label: Control group
arm group type: No Intervention
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: Recovery program
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)
arm group label: Recovery group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Mental Disorders