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Mental IllnessNCT04400565

The Effectiveness of a Recovery Program 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 65 years
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
26 Jun 2019to 21 Jul 2020
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of mental illness
  • lived in community

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Cheng Kung University Hospital

    Tainan

Other trials in Taiwan

About this study

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.

Read the 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.

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 groupBehavioural

    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)

Study groups in NCT04400565
Study groupRoleWhat they receive
Recovery groupExperimentalThe 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.
Receives: Behavioral: Recovery group
Control groupNo interventionThe control group will receive a spiritual book and complete the questionnaires at the same time as the recovery group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from Baseline at 10 weeks, 20 weeks and 44 weeks

Secondary outcomes (4)
  1. 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).

    Measured: Change from Baseline at 10 weeks, 20 weeks and 44 weeks

  2. 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).

    Measured: Change from Baseline at 10 weeks, 20 weeks and 44 weeks

  3. 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.

    Measured: Change from Baseline at 10 weeks, 20 weeks and 44 weeks

  4. 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)

    Measured: Change from Baseline at 10 weeks, 20 weeks and 44 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start26 Jun 2019
  3. Primary completion21 Jul 2020
  4. Study completion21 Jul 2020

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04400565
Sponsor's protocol ID
B-BR-107-044
Status last verified
Jul 2021
First submitted
21 May 2020
Last updated
13 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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 2 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 13 Nov 2023. 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 (SRS) (time frame: Change from Baseline at 10 weeks, 20 weeks and 44 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 13 Nov 2023.

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