Psychotic DisordersHOP-NORNCT06384755
Honest Open Proud for Psychotic and Bipolar Disorder in Norway
A study testing Honest Open Proud program in people with Psychotic Disorders and Bipolar Disorder, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders, Bipolar Disorder, Disclosure
- What is being tested?
- Honest Open Proud program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- 20 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed current psychotic (F 20) or bipolar disorder (F 30) according to International Classification of Diseases 10th Revision (ICD-10)
- Age 18 to 65
- Ability to provide written informed consent.
- Fluent in Norwegian (needed for self-report measures)
- Experience difficulties with stigma and disclosure regarding mental illness.
Who cannot join
- Intellectual disability
- Organic disorders
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital
Oslo, 0351
Mari Husa, MD, 0047 95837846, mahusa@ous-hf.no
Magnus Engen, PhD, 0047 41004660, UXENMF@ous.hf.no
- Not yet recruiting
Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital
Oslo, 1281
Hilde Aasli Daler, MSc, 0047 23023100, uxruhi@ous-hf.no
Marit Haram, PhD, 0047 21077000, mharam@ous.hf.no
About this study
Official title: Evaluation of a Norwegian Adaptation of the Honest Open Proud Program for Adults With Psychotic and Bipolar Disorders in an Outpatient Setting
The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting.
Read the detailed description
Because people with mental illness experience both public and personal stigma, which is related to lower levels of recovery and wellbeing, it is common to struggle with decisions regarding potential disclosure of mental health difficulties or diagnoses. There are pros and cons with both disclosure and secrecy. Disclosure can lead to social support, followed by improved mental health and reduced public stigma, but also stigmatization and social exclusion. Secrecy can prevent stigmatization but may also lead to social isolation and thus poorer mental health and increased public stigma. Therefore, people with mental illness need help to make strategic decisions about whether, and if so, to whom, when and how they wish to disclose their mental health problems. As contact with other people with mental health difficulties is crucial to anti-stigma interventions, people with mental illness could benefit from meeting peers, especially as role models. This suggests that peer facilitators could be an important feature in a program aiming to help people with mental illness handle stigma and challenges related to disclosure. The Honest Open Proud (HOP) program was developed for this purpose. Because people with psychotic and bipolar disorders experience particularly high levels of both public and personal stigma, which negatively impacts their recovery rates, they may be especially in need of the HOP program.
The investigators aim to evaluate whether a Norwegian adaptation of the HOP group program, which is facilitated by peers, is feasible and acceptable for people with psychotic and bipolar disorders in an outpatient setting. Moreover, whether it helps them handle stigma and disclosure related decisions.
The investigators propose a pilot randomized controlled trial, comparing an intervention group receiving a 6-week Norwegian adaptation of the HOP program to a waiting list control group. Both groups receive treatment as usual. The main research question is whether this intervention is feasible and acceptable. However, efficacy measures tapping change in stigma and disclosure distress, as well as recovery and wellbeing, from before to after the intervention, were included. The aim is to find what effect sizes can be expected in future larger studies in Norway, rather than to find significant differences in effect sizes.
- Conditions
- Psychotic Disorders, Bipolar Disorder, Disclosure
- Being tested
- Honest Open Proud program
- Keywords
- Honest Open Proud program, Psychotic and Bipolar disorders
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honest Open Proud programBehavioural
Also called Coming Out Proud (COP)
The HOP program involves peer facilitated sessions, in which different stigma and disclosure related topics are introduced to the group, relevant tasks are completed individually, followed by group or two-and-two discussions related to the following topics: week 1 = pros and cons with disclosure, week 2 = different ways of disclosing, week 3 = formulating individual decisions of disclosure, week 6 = evaluating disclosure or non-disclosure in practice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group: receives the HOP program consisting of four 2-hour sessions divided between week 1, week 2, week 3 and week 6, in groups of 4-10 participants, using a Norwegian adaptation of HOP workbook. The intervention group also receives treatment as usual, consisting of weekly or monthly appointments with a mental health care professional at an outpatient unit in the public mental health care service. The appointments can involve medication management, psychoeducation, support therapy or psychotherapy. Receives: Behavioral: Honest Open Proud program |
| Waiting list control group | No intervention | Waiting list control group: receives only treatment as usual, consisting of weekly or monthly appointments with a mental health care professional at an outpatient unit in the public mental health care service. The appointments can involve medication management, psychoeducation, support therapy or psychotherapy. They are offered the HOP program after the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)
8 items, from 1 (strongly disagree) to 7 (strongly agree)
Measured: Change from T0 to T1 and T2 (assessed at T0 = week 0; T1 =week 3; T2 = week 6)
Secondary outcomes (7)
Disclosure Distress (Rüsch et al., 2014a)
1 item "In general, how distressed or worried are you in terms of secrecy or disclosure of your mental illness to others?", from 1 (not at all) to 7 (very much)
Measured: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007)
14-items, from 1 (not at all) to 5 (all the time)
Measured: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Satisfaction with life (Lehman, 1988)
1 item from Lehmans Quality of Life Scale, from 1 (very dissatisfied) to 7 (very satisfied)
Measured: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007)
15 items short version, from 0 (strongly disagree) to 4 (strongly agree)
Measured: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014)
10-item short version, from 1 (strongly disagree ) to 4 (strongly agree )
Measured: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009)
9 items, 0 (not at all) to 3 (nearly every day)
Measured: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006)
7 items, from 0 (not at all) to 3 (nearly every day)
Measured: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start20 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Carmen Simonsen, Oslo University Hospital
- Investigators
- Carmen Simonsen, PhD, Principal investigator, Department of Psychology, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384755
- Sponsor's protocol ID
- 645788
- Other IDs
- 2022_HE2_409659, 645788
- Acronym
- HOP-NOR
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol can be shared, but not the the actual data.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Norwegian Adaptation of the Honest Open Proud Program for Adults With Psychotic and Bipolar Disorders in an Outpatient Setting
- ClinicalTrials.gov ID
- NCT06384755
- Acronym / sponsor ID
- HOP-NOR / 645788
- Conditions
- Psychotic Disorders, Bipolar Disorder, Disclosure
- Keywords
- Honest Open Proud program, Psychotic and Bipolar disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2024 (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.
The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting.
Detailed description
Because people with mental illness experience both public and personal stigma, which is related to lower levels of recovery and wellbeing, it is common to struggle with decisions regarding potential disclosure of mental health difficulties or diagnoses. There are pros and cons with both disclosure and secrecy. Disclosure can lead to social support, followed by improved mental health and reduced public stigma, but also stigmatization and social exclusion. Secrecy can prevent stigmatization but may also lead to social isolation and thus poorer mental health and increased public stigma. Therefore, people with mental illness need help to make strategic decisions about whether, and if so, to whom, when and how they wish to disclose their mental health problems. As contact with other people with mental health difficulties is crucial to anti-stigma interventions, people with mental illness could benefit from meeting peers, especially as role models. This suggests that peer facilitators could be an important feature in a program aiming to help people with mental illness handle stigma and challenges related to disclosure. The Honest Open Proud (HOP) program was developed for this purpose. Because people with psychotic and bipolar disorders experience particularly high levels of both public and personal stigma, which negatively impacts their recovery rates, they may be especially in need of the HOP program.
The investigators aim to evaluate whether a Norwegian adaptation of the HOP group program, which is facilitated by peers, is feasible and acceptable for people with psychotic and bipolar disorders in an outpatient setting. Moreover, whether it helps them handle stigma and disclosure related decisions.
The investigators propose a pilot randomized controlled trial, comparing an intervention group receiving a 6-week Norwegian adaptation of the HOP program to a waiting list control group. Both groups receive treatment as usual. The main research question is whether this intervention is feasible and acceptable. However, efficacy measures tapping change in stigma and disclosure distress, as well as recovery and wellbeing, from before to after the intervention, were included. The aim is to find what effect sizes can be expected in future larger studies in Norway, rather than to find significant differences in effect sizes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Honest Open Proud programIntervention group: receives the HOP program consisting of four 2-hour sessions divided between week 1, week 2, week 3 and week 6, in groups of 4-10 participants, using a Norwegian adaptation of HOP workbook. The intervention group also receives treatment as usual, consisting of weekly or monthly appointments with a mental health care professional at an outpatient unit in the public mental health care service. The appointments can involve medication management, psychoeducation, support therapy or psychotherapy. |
| Waiting list control group | No intervention | –Waiting list control group: receives only treatment as usual, consisting of weekly or monthly appointments with a mental health care professional at an outpatient unit in the public mental health care service. The appointments can involve medication management, psychoeducation, support therapy or psychotherapy. They are offered the HOP program after the trial. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed current psychotic (F 20) or bipolar disorder (F 30) according to International Classification of Diseases 10th Revision (ICD-10)
- Age 18 to 65
- Ability to provide written informed consent.
- Fluent in Norwegian (needed for self-report measures)
- Experience difficulties with stigma and disclosure regarding mental illness.
Key exclusion criteria (2 listed)
- Intellectual disability
- Organic disorders
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 |
|---|---|---|
| Honest Open Proud programAlso: Coming Out Proud (COP)The HOP program involves peer facilitated sessions, in which different stigma and disclosure related topics are introduced to the group, relevant tasks are completed individually, followed by group or two-and-two discussions related to the following topics: week 1 = pros and cons with disclosure, week 2 = different ways of disclosing, week 3 = formulating individual decisions of disclosure, week 6 = evaluating disclosure or non-disclosure in practice. | Behavioural | Intervention group |
Primary outcome
Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)
Time frame: Change from T0 to T1 and T2 (assessed at T0 = week 0; T1 =week 3; T2 = week 6)
8 items, from 1 (strongly disagree) to 7 (strongly agree)
7 secondary outcomes
Disclosure Distress (Rüsch et al., 2014a)
Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007)
Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Satisfaction with life (Lehman, 1988)
Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007)
Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014)
Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009)
Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006)
Time frame: Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Description of the project in NorwegianLink provided by the sponsor.
- Individual participant dataSharing planned: No. The study protocol can be shared, but not the the actual data.
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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.
Carmen Simonsen, PhD principal investigator
Department of Psychology, University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honest Open Proud program in people with Psychotic Disorders and Bipolar Disorder, run by Oslo University Hospital at 2 sites in Norway.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen Simonsen, PhD (0047 90988741, carmen.simonsen@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009) (time frame: Change from T0 to T1 and T2 (assessed at T0 = week 0; T1 =week 3; T2 = week 6)). 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 2 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.