Honest Open Proud for Psychotic and Bipolar Disorder in Norway
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Intellectual disability
Organic disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Honest Open Proud program
BehavioralThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Waiting list control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
Change from T0 to T1 and T2 (assessed at T0 = week 0; T1 =week 3; T2 = week 6)Secondary outcomes
1
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)
Time frame
Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)2
Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007)
14-items, from 1 (not at all) to 5 (all the time)
Time frame
Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)3
Satisfaction with life (Lehman, 1988)
1 item from Lehmans Quality of Life Scale, from 1 (very dissatisfied) to 7 (very satisfied)
Time frame
Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)4
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)
Time frame
Change from T0 to T2 (assessed at T0 = week 0; T2 = week 6)Other outcomes
1
Disclosure
"Have you disclosed your mental illness the last three (or six) weeks?", YES/NO "How satisfied are you with that?", from 1 (very dissatisfied) to 7 (very satisfied)
Time frame
Assessed at T1 and T2 (T1= week 3 and T2 = week 6)2
Feasibility of HOP program
Recruitment rates (numbers of participants in number of weeks) and drop-out rates.
Time frame
Tracked during trial and evaluated after completion (T2 = week 6)3
Acceptability of HOP program participants
Semi-structured focus-group interview about acceptability with HOP program participants
Time frame
Assessed after T2 = week 64
Acceptability of HOP peer facilitators
Semi-structured focus-group interview about acceptability with HOP peer facilitators
Time frame
Assessed after T2 = week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
University of Oslo
Collaborator
Source ClinicalTrials.gov