Self-stigmaNCT04168918
Effectiveness of a Group Psychological Intervention in Reducing Self-stigma Among Patients With Mental Disorders
A study testing Group psychological Intervention in people with Self-stigma and Self Efficacy, run by The University of The West Indies at 1 site in Barbados.
Trial summary
At the Psychiatric Hospital, there are limited mental health professionals to offer the standard of care that is expected at a psychiatric institution. Psychotherapy is most affected. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-stigma, Self Efficacy, Quality of Life
- What is being tested?
- Group psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBarbados
- Study dates
- 7 Jan 2020to 6 Mar 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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Attend clinic every 2 weeks
- Willingness to attend all sessions
Who cannot join
- Cognitive impairment that limits the participant from understanding material and answering questions
Trial locations and contacts
1 site in 1 country.
Barbados1 site
The Psychiatric Hospital
Bridgetown
About this study
Official title: Efficacy of a Group Psychological Intervention in Reducing Self-Stigma Among Outpatients at the Psychiatric Hospital: A Randomized Controlled Trial
At the Psychiatric Hospital, there are limited mental health professionals to offer the standard of care that is expected at a psychiatric institution. Psychotherapy is most affected. However, there are mental health professionals in training and long waiting times before clients are seen, which provides an opportunity for an intervention to be carried out. The purpose of the study therefore, is to determine whether a group psychological intervention can primarily reduce self-stigma among outpatients at the Psychiatric Hospital. The intervention's effects on self-efficacy and quality of life will also be assessed.
Read the detailed description
Study population: outpatients in the Outpatient Department at The Psychiatric Hospital
Target population: clients with two-weekly appointments
Procedures for recruitment and consent
Participants will be chosen using available lists of persons who come to clinic on a two-weekly basis on four(4) days of the week (every day except the day the Principal Investigator is responsible for conducting clinic), for two consecutive weeks. Twenty-six will be chosen each day (for eight (8) days) and randomized to intervention and treatment-as-usual (Thirteen (13) persons to each group). Participants will be selected based on the inclusion and exclusion criteria and consent will be obtained.
Randomization will be carried out by Stata 14
Sample size
Using the means and standard deviations for the Internalized Stigma of Mental Illness Inventory (ISMI) used in a randomized controlled trial and Stata 14 for sample size calculation, the sample size recommended is eighty-four (84) with forty-two (42) per group. This will give a power (for the study) of eighty per cent (80%).
However, the aim will be two-hundred and eight (208) clients based on the following:
- Target population: two-hundred and fifty (250). Approximately twenty-five (25) patients come to clinic daily, most of whom come on a two-weekly basis. Therefore, this will allow eighty-three per cent (83%) of the population to be part of the study.
- Maximum number of persons in a group- thirteen (13)
- Maximum number of groups that can be held before clinic begins- one (1)
- Time for thesis
- Taking into account that persons may not be willing to participate and so aiming to include as many persons as possible
Method
There will be six (6) sessions covering six (6) topics. One topic will be covered at each session. Sessions will last sixty (60) to ninety (90) minutes.
Data collection
- Administration of the ISMI, the General self-efficacy scale and World Health Organization (WHO)5 Well Being Index and a questionnaire to the intervention and control groups before the intervention and after the intervention. This will be done by a health professional not related to the study.
Permission was obtained from producer of ISMI. WHO5 Well-Being Index is free to use and General self-efficacy scale does not require permission, once referenced.
All three scales have been found to be valid and reliable.
- A pilot study on 26 persons will be conducted to test the questionnaire and scales.
- To ensure accurate completion of questionnaire and scales by each participant, each item will be read and explained before participants asked to select answer. Questions on clarification will be encouraged.Time will also be given after, for participants to read through answers if needed. Additionally, when collecting questionnaires and scales, the mental health professional will scan through to ensure all questions answered.
Questionnaires and scales will be identified using participants' record numbers to facilitate verification of information such as whether medications or health care provider changed during the course of the intervention.
Statistical analyses
- Summary statistics
- Regression analysis of endpoint score adjusting baseline score and looking at the difference between the intervention and treatment-as-usual groups.
Intention to treat analysis will be used.
- Software to be used: Stata 14 Missing entries will be included in the analysis Data handling and record keeping
Questionnaires kept in secure room for at least five (5) years
- Conditions
- Self-stigma, Self Efficacy, Quality of Life
- Being tested
- Group psychological Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group psychological InterventionBehavioural
There will be 6 sessions covering 6 topics (Understanding mental disorders, Self-stigma, Social support, Substance use and mental illness, Self-help strategies, Available mental health services). Each session will begin with welcoming, reviewing what was done in the last session and home assignments (where applicable), question-guided discussion, lecture, group sharing and home assignment
| Study group | Role | What they receive |
|---|---|---|
| Group Psychological Intervention | Experimental | One topic will be discussed at each of the six sessions using some principles from cognitive behavioral therapy and psychoeducation. Receives: Behavioral: Group psychological Intervention |
| Treatment-as-usual | No intervention | Participants will receive their usual care which involves being seen by a mental health professional (psychologist, psychiatrist/resident in psychiatry, or mental health nurse). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-stigma
Mean Change from Baseline in scores on the Internalized Stigma of Mental Illness Inventory (ISMI) after 6 sessions Each item is scored 1-4 (1=strongly disagree;4=strongly agree), yielding a total between 29 and 116. Higher scores indicate greater self-stigma.
Measured: From enrollment to the end of intervention at 12 weeks
Secondary outcomes (2)
Change in self-efficacy: General self-efficacy scale
Mean Change from Baseline in scores on the General self-efficacy scale after 6 sessions Each item is scored 1-4 (1=not true at all; 4=exactly true) yielding a total between 10 and 40. Higher scores indicate more self-efficacy
Measured: From enrollment to the end of intervention at 12 weeks
Change in quality of life: WHO5 Well Being Index
Mean Change from Baseline in scores on the WHO5 Well Being Index after 6 sessions Each item is scored 0-5 (0=at no time; 5=all of the time) yielding between 0 and 25. Higher scores indicate better quality of life.
Measured: From enrollment to the end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start7 Jan 2020
- Primary completion24 Jan 2020
- Study completion6 Mar 2020
Why it stopped: Most participants did not complete the post-intervention questionnaire
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Self-stigmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Fifty per cent receive psychological intervention and fifty per cent receive treatment-as-usual
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shani Venner, The University of The West Indies
- Investigators
- Shani KM Venner, MBBS,MPH, Principal investigator, University of the West Indies-Cave Hill Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168918
- Sponsor's protocol ID
- 191002-A
- Status last verified
- May 2021
- First submitted
- 14 Nov 2019
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cuhadar D, Cam MO. Effectiveness of psychoeducation in reducing internalized stigmatization in patients with bipolar disorder. Arch Psychiatr Nurs. 2014 Feb;28(1):62-6. doi: 10.1016/j.apnu.2013.10.008. Epub 2013 Oct 28.
PubMed 24506989Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON, 1995
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Chang CC, Wu TH, Chen CY, Wang JD, Lin CY. Psychometric evaluation of the internalized stigma of mental illness scale for patients with mental illnesses: measurement invariance across time. PLoS One. 2014 Jun 2;9(6):e98767. doi: 10.1371/journal.pone.0098767. eCollection 2014.
PubMed 24887440
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Group Psychological Intervention in Reducing Self-Stigma Among Outpatients at the Psychiatric Hospital: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04168918
- Acronym / sponsor ID
- 191002-A
- Conditions
- Self-stigma, Self Efficacy, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Most participants did not complete the post-intervention questionnaire
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At the Psychiatric Hospital, there are limited mental health professionals to offer the standard of care that is expected at a psychiatric institution. Psychotherapy is most affected. However, there are mental health professionals in training and long waiting times before clients are seen, which provides an opportunity for an intervention to be carried out. The purpose of the study therefore, is to determine whether a group psychological intervention can primarily reduce self-stigma among outpatients at the Psychiatric Hospital. The intervention's effects on self-efficacy and quality of life will also be assessed.
Detailed description
Study population: outpatients in the Outpatient Department at The Psychiatric Hospital
Target population: clients with two-weekly appointments
Procedures for recruitment and consent
Participants will be chosen using available lists of persons who come to clinic on a two-weekly basis on four(4) days of the week (every day except the day the Principal Investigator is responsible for conducting clinic), for two consecutive weeks. Twenty-six will be chosen each day (for eight (8) days) and randomized to intervention and treatment-as-usual (Thirteen (13) persons to each group). Participants will be selected based on the inclusion and exclusion criteria and consent will be obtained.
Randomization will be carried out by Stata 14
Sample size
Using the means and standard deviations for the Internalized Stigma of Mental Illness Inventory (ISMI) used in a randomized controlled trial and Stata 14 for sample size calculation, the sample size recommended is eighty-four (84) with forty-two (42) per group. This will give a power (for the study) of eighty per cent (80%).
However, the aim will be two-hundred and eight (208) clients based on the following:
- Target population: two-hundred and fifty (250). Approximately twenty-five (25) patients come to clinic daily, most of whom come on a two-weekly basis. Therefore, this will allow eighty-three per cent (83%) of the population to be part of the study.
- Maximum number of persons in a group- thirteen (13)
- Maximum number of groups that can be held before clinic begins- one (1)
- Time for thesis
- Taking into account that persons may not be willing to participate and so aiming to include as many persons as possible
Method
There will be six (6) sessions covering six (6) topics. One topic will be covered at each session. Sessions will last sixty (60) to ninety (90) minutes.
Data collection
- Administration of the ISMI, the General self-efficacy scale and World Health Organization (WHO)5 Well Being Index and a questionnaire to the intervention and control groups before the intervention and after the intervention. This will be done by a health professional not related to the study.
Permission was obtained from producer of ISMI. WHO5 Well-Being Index is free to use and General self-efficacy scale does not require permission, once referenced.
All three scales have been found to be valid and reliable.
- A pilot study on 26 persons will be conducted to test the questionnaire and scales.
- To ensure accurate completion of questionnaire and scales by each participant, each item will be read and explained before participants asked to select answer. Questions on clarification will be encouraged.Time will also be given after, for participants to read through answers if needed. Additionally, when collecting questionnaires and scales, the mental health professional will scan through to ensure all questions answered.
Questionnaires and scales will be identified using participants' record numbers to facilitate verification of information such as whether medications or health care provider changed during the course of the intervention.
Statistical analyses
- Summary statistics
- Regression analysis of endpoint score adjusting baseline score and looking at the difference between the intervention and treatment-as-usual groups.
Intention to treat analysis will be used.
- Software to be used: Stata 14 Missing entries will be included in the analysis Data handling and record keeping
Questionnaires kept in secure room for at least five (5) years
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fifty per cent receive psychological intervention and fifty per cent receive treatment-as-usual
| Arm | Type | Receives |
|---|---|---|
| Group Psychological Intervention | Experimental | Behavioral: Group psychological InterventionOne topic will be discussed at each of the six sessions using some principles from cognitive behavioral therapy and psychoeducation. |
| Treatment-as-usual | No intervention | –Participants will receive their usual care which involves being seen by a mental health professional (psychologist, psychiatrist/resident in psychiatry, or mental health nurse). |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Attend clinic every 2 weeks
- Willingness to attend all sessions
Key exclusion criteria (1 listed)
- Cognitive impairment that limits the participant from understanding material and answering questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group psychological InterventionThere will be 6 sessions covering 6 topics (Understanding mental disorders, Self-stigma, Social support, Substance use and mental illness, Self-help strategies, Available mental health services). Each session will begin with welcoming, reviewing what was done in the last session and home assignments (where applicable), question-guided discussion, lecture, group sharing and home assignment | Behavioural | Group Psychological Intervention |
Primary outcome
Change in self-stigma
Time frame: From enrollment to the end of intervention at 12 weeks
Mean Change from Baseline in scores on the Internalized Stigma of Mental Illness Inventory (ISMI) after 6 sessions Each item is scored 1-4 (1=strongly disagree;4=strongly agree), yielding a total between 29 and 116. Higher scores indicate greater self-stigma.
2 secondary outcomes
Change in self-efficacy: General self-efficacy scale
Time frame: From enrollment to the end of intervention at 12 weeks
Change in quality of life: WHO5 Well Being Index
Time frame: From enrollment to the end of intervention at 12 weeks
Results and safety
The study was stopped early (reason given: Most participants did not complete the post-intervention questionnaire). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Background: PubMed 24506989Cuhadar D, Cam MO. Effectiveness of psychoeducation in reducing internalized stigmatization in patients with bipolar disorder. Arch Psychiatr Nurs. 2014 Feb;28(1):62-6. doi: 10.1016/j.apnu.2013.10.008. Epub 2013 Oct 28.
- BackgroundSchwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON, 1995
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Background: PubMed 24887440Chang CC, Wu TH, Chen CY, Wang JD, Lin CY. Psychometric evaluation of the internalized stigma of mental illness scale for patients with mental illnesses: measurement invariance across time. PLoS One. 2014 Jun 2;9(6):e98767. doi: 10.1371/journal.pone.0098767. eCollection 2014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shani KM Venner, MBBS,MPH principal investigator
University of the West Indies-Cave Hill Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group psychological Intervention in people with Self-stigma and Self Efficacy, run by The University of The West Indies at 1 site in Barbados.
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: stopped early, as of the sponsor's last update on 21 May 2021. 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 Barbados. 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 was stopped early (reason given: Most participants did not complete the post-intervention questionnaire). Results are not available in the source record.
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?
Change in self-stigma (time frame: From enrollment to the end of intervention at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04168918, which also lists 4 linked publications.
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 21 May 2021.