Psychotic DisordersNCT02360566
Participatory Video as a Recovery-Oriented Intervention in Early Psychosis
A study testing Participatory Video Intervention for Early Psychosis in people with Psychotic Disorders and Schizophrenia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Prior research has shown that people with psychotic illnesses, like schizophrenia, who make sense of and meaningfully integrate their psychotic experiences into their life story are more likely to recover from their illness. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia
- What is being tested?
- Participatory Video Intervention for Early Psychosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants will be current outpatients of the Prevention and Early intervention Program for Psychoses (PEPP) at LHSC.
- PEPP only accepts patients with a first onset primary psychotic illness that have not been treated with an antipsychotic for longer than one month.
- Study participants must be within their first 3 years of being accepted into PEPP.
- Participants must be fluent in English, as determined by referring clinicians or researchers (in the case of advertisement referred participants) in order to meaningfully participate in the PV intervention and complete the assessment tools.
Who cannot join
- Potential participants that show high levels of disorganized or disruptive behaviour (as determined by a cut off score of 4 or 5 on the Positive Formal
- Thought Disorder or Bizarre Behaviour items of the Scale for the Assessment of Positive Symptoms [SAPS]) such that they will not be able to meaningfully participate in the MAC intervention will be excluded from the study.
- Participants must not be simultaneously participating in any other research projects involving active interventions at PEPP.
About this study
Official title: The Novel Use of Participatory Video as a Recovery-Oriented Intervention in Early Psychosis: A Pilot Study
Prior research has shown that people with psychotic illnesses, like schizophrenia, who make sense of and meaningfully integrate their psychotic experiences into their life story are more likely to recover from their illness. This process of developing a coherent narrative seems especially relevant for young people who are experiencing their first episode of psychosis. There is a need for interventions that can help facilitate the formation of recovery-oriented narratives, particularly in the early stage of illness. Participatory video is a group process that involves the facilitated creation of short documentary-style videos in which individuals are supported to reflect on and tell their personal stories. Although it has been used to foster self-identity, self-empowerment and "give voice" to a variety of marginalized and stigmatized populations, its use and evaluation as a clinical intervention has been limited.
The purpose of this study is to determine whether the novel use of participatory video facilitate narrative development and promote recovery for individuals with early psychosis is an effective, feasible, and acceptable means of treating youth in the early stages of psychotic illnesses. Although the current study is hypothesis generating in nature, the investigators are expecting that participating in the Participatory Video intervention will result in improvements in narrative development, symptoms, self-perceived recovery, self-esteem, self-stigma, social functioning and hope. Additionally, the investigators expect that Participatory Video intervention will prove to be acceptable to participants and a feasible intervention for early psychotic disorders.
Read the detailed description
The purpose of this study is to determine whether a novel 12-session Participatory Video intervention, is an effective, feasible, and acceptable means of treating people in the early stages of psychotic illnesses.
We intend to randomly assign 20 patients being treated for psychotic illnesses in an early intervention program to a Participatory Video intervention group or treatment as usual group (control). Participants who are randomly assigned to the Participatory Video intervention will take part in 12 expert-facilitated group-based workshops over a period of 6 months, in which they will learn how to develop, film and produce a documentary-style video of their experiences with psychosis. At the end of the 12 workshops participants will have worked together to produce a group documentary video about their experiences with psychosis and, should they wish, individual videos about their own personal experiences with psychosis. Participants in the Participatory Video intervention group will receive the intervention in addition to any treatment they would usually receive through the early psychosis program. Those assigned to the treatment as usual group will continue to receive the standard care available to them in the early psychosis program.
Participants will be evaluated at baseline, at 6-months (immediately post-intervention) and at 9 months (3 months post-intervention) on a number measures. Participatory Video intervention acceptability will be assessed through the Client Satisfaction Questionnaire and qualitative interviews, feasibility will be assessed through recruitment, consent and completion rates, and efficacy will be assessed on measures of symptoms, functioning, subjective recovery, metacognitive capacity and narrative development.
- Conditions
- Psychotic Disorders, Schizophrenia
- Being tested
- Participatory Video Intervention for Early Psychosis
- Keywords
- Psychosis, Schizophrenia, Participatory Video, Narrative
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory Video Intervention for Early PsychosisBehavioural
The Participatory Video intervention consists of 12 semi-structured, 2 hour group workshops over the course of a 6-month time period. Through facilitated discussion, participants will learn how to effectively work collaboratively as a member of the video production team. Together, they will choose what story of their shared experience with psychosis they would like to tell through documentary-video and how they plan to share it. Participants will be trained to operate all equipment required to bring their vision to life. Individuals will also have the opportunity, during the Participatory Video process, to create and share their own video clips, independent of the group, allowing participants to share their own video-narrative with others (friends, family members, public) as a means of engaging in dialogue around their personal experience with psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Participatory Video Intervention Group | Experimental | The Participatory Video intervention consists of 12 semi-structured, 2 hour group workshops over the course of a 6-month time period. Through facilitated discussion, participants will learn how to effectively work collaboratively as a member of the video production team. Together, they will choose what story of their shared experience with psychosis they would like to tell through documentary-video and how they plan to share it. Participants will be trained to operate all equipment required to bring their vision to life. Individuals will also have the opportunity, during the Participatory Video process, to create and share their own video clips, independent of the group, allowing participants to share their own video-narrative with others (friends, family members, public) as a means of engaging in dialogue around their personal experience with psychosis. Receives: Behavioral: Participatory Video Intervention for Early Psychosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for Assessment of Positive Symptoms (SAPS)
Measured: Baseline, Change from Baseline in SAPS at 6 months, change from baseline in SAPS at 9 months
Scale for Assessment of Negative Symptoms (SANS)
Measured: Baseline, Change from Baseline in SANS at 6 months, change from baseline in SANS at 9 months
Rosenberg Self-Esteem Schedule (RSES)
Measured: Baseline, Change from Baseline in RSES at 6 months, change from baseline in RSES at 9 months
Self-stigma of Mental Illness Scale (SSMIS)
Measured: Baseline, Change from Baseline in SSMIS at 6 months, change from baseline in SSMIS at 9 months
The Beck Hopelessness Scale (BHS)
Measured: Baseline, Change from Baseline in BHS at 6 months, change from baseline in BHS at 9 months
Maryland Assessment of Recovery in People with Serious Mental Illness Scale (MARS)
Measured: Baseline, Change from Baseline in MARS at 6 months, change from baseline in MARS at 9 months
Social Functioning Scale (SFS)
Measured: Baseline, Change from Baseline in SFS at 6 months, change from baseline in SFS at 9 months
Profile of Mood States (POMS)
Measured: Baseline, Change from Baseline in POMS at 6 months, change from baseline in POMS at 9 months
Client Satisfaction Questionnaire-8
Measured: at 6 months (only to those in the Participatory Video Intervention Group)
Scale to Assess Narrative Development (STAND)
Measured: at 6 months
Metacognition Assessment Scale-Abbreviated (MAS-A)
Measured: at 6 months
Qualitative Focus Group - Participant descriptions of their experience with Participatory Video and suggestions for how to improve the Participatory Video intervention
Measured: at 6 months (only for those in the Participatory Video intervention group)
Individual Semi-Structured Interviews - Participant description of their individual experience with the PV intervention group and any changes they feel it may have engendered in their life
Measured: at 9 months (only for those in the Participatory Video-intervention group)
Recruitment Rates
Measured: baseline
Consent Rates
Measured: baseline
Completion Rates
Measured: at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- ProjectVideo Inc., London Health Sciences Centre, University of Western Ontario, Canada
- Responsible party
- Principal investigator, Arlene MacDougall, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Arlene MacDougall, M.Sc., M.D., Principal investigator, London Health Sciences Centre/University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360566
- Sponsor's protocol ID
- 8211
- Status last verified
- Sep 2017
- First submitted
- 2 Feb 2015
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
France CM, Uhlin BD. Narrative as an outcome domain in psychosis. Psychol Psychother. 2006 Mar;79(Pt 1):53-67. doi: 10.1348/147608305X41001.
PubMed 16611421Roe D, Davidson L. Self and narrative in schizophrenia: time to author a new story. Med Humanit. 2005 Dec;31(2):89-94. doi: 10.1136/jmh.2005.000214.
PubMed 23674667Chadwick PK. Peer-professional first-person account: schizophrenia from the inside--phenomenology and the integration of causes and meanings. Schizophr Bull. 2007 Jan;33(1):166-73. doi: 10.1093/schbul/sbl034. Epub 2006 Sep 14.
PubMed 16973785Lysaker PH, Buck KD, Ringer J. The recovery of metacognitive capacity in schizophrenia across 32 months of individual psychotherapy: A case study. Psychotherapy Research 17(6): 713-720, 2007.
Windell D, Norman RM. A qualitative analysis of influences on recovery following a first episode of psychosis. Int J Soc Psychiatry. 2013 Aug;59(5):493-500. doi: 10.1177/0020764012443751. Epub 2012 Apr 24.
PubMed 22532125McAdams DP, McLean KC. Narrative identity. Current Directions in Psychological Science 22(3): 233-238, 2013.
Cavelti M, Kvrgic S, Beck EM, Rusch N, Vauth R. Self-stigma and its relationship with insight, demoralization, and clinical outcome among people with schizophrenia spectrum disorders. Compr Psychiatry. 2012 Jul;53(5):468-79. doi: 10.1016/j.comppsych.2011.08.001. Epub 2011 Sep 28.
PubMed 21956043Greben M, Schweitzer RD, Bargenquast R. Mechanisms of change in psychotherapy for people diagnosed with schizophrenia: the role of narrative reflexivity in promoting recovery. The Australian Journal of Rehabilitation Counselling 20(1): 1-14, 2014.
Roe D, Hasson-Ohayon I, Mashiach-Eizenberg M, Derhy O, Lysaker PH, Yanos PT. Narrative enhancement and cognitive therapy (NECT) effectiveness: a quasi-experimental study. J Clin Psychol. 2014 Apr;70(4):303-12. doi: 10.1002/jclp.22050. Epub 2013 Oct 2.
PubMed 24114797White SA. (2003). Participatory video: Images that transform and empower. Sage.
Yang KH. (2012). Reflexivity, participation, and video. The handbook of participatory video, 100-114.
Shaw J, Robertson C. (1997). Participatory video: a practical approach to using video creatively in group development work. London (ua): Routledge.
Bery R. (2003). Participatory video that empowers. Participatory video: Images that transform and empower, 102-121.
Luttrell W, Restler V, Fontaine C. Youth Video-Making. Handbook of Participatory Video, 164, 2012.
Norman CD, Yip AL. eHealth promotion and social innovation with youth: using social and visual media to engage diverse communities. Stud Health Technol Inform. 2012;172:54-70.
PubMed 22910502
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Novel Use of Participatory Video as a Recovery-Oriented Intervention in Early Psychosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT02360566
- Acronym / sponsor ID
- 8211
- Conditions
- Psychotic Disorders, Schizophrenia
- Keywords
- Psychosis, Schizophrenia, Participatory Video, Narrative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- ProjectVideo Inc., London Health Sciences Centre, University of Western Ontario, Canada
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Feb 2015 (estimated)
- 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.
Prior research has shown that people with psychotic illnesses, like schizophrenia, who make sense of and meaningfully integrate their psychotic experiences into their life story are more likely to recover from their illness. This process of developing a coherent narrative seems especially relevant for young people who are experiencing their first episode of psychosis. There is a need for interventions that can help facilitate the formation of recovery-oriented narratives, particularly in the early stage of illness. Participatory video is a group process that involves the facilitated creation of short documentary-style videos in which individuals are supported to reflect on and tell their personal stories. Although it has been used to foster self-identity, self-empowerment and "give voice" to a variety of marginalized and stigmatized populations, its use and evaluation as a clinical intervention has been limited.
The purpose of this study is to determine whether the novel use of participatory video facilitate narrative development and promote recovery for individuals with early psychosis is an effective, feasible, and acceptable means of treating youth in the early stages of psychotic illnesses. Although the current study is hypothesis generating in nature, the investigators are expecting that participating in the Participatory Video intervention will result in improvements in narrative development, symptoms, self-perceived recovery, self-esteem, self-stigma, social functioning and hope. Additionally, the investigators expect that Participatory Video intervention will prove to be acceptable to participants and a feasible intervention for early psychotic disorders.
Detailed description
The purpose of this study is to determine whether a novel 12-session Participatory Video intervention, is an effective, feasible, and acceptable means of treating people in the early stages of psychotic illnesses.
We intend to randomly assign 20 patients being treated for psychotic illnesses in an early intervention program to a Participatory Video intervention group or treatment as usual group (control). Participants who are randomly assigned to the Participatory Video intervention will take part in 12 expert-facilitated group-based workshops over a period of 6 months, in which they will learn how to develop, film and produce a documentary-style video of their experiences with psychosis. At the end of the 12 workshops participants will have worked together to produce a group documentary video about their experiences with psychosis and, should they wish, individual videos about their own personal experiences with psychosis. Participants in the Participatory Video intervention group will receive the intervention in addition to any treatment they would usually receive through the early psychosis program. Those assigned to the treatment as usual group will continue to receive the standard care available to them in the early psychosis program.
Participants will be evaluated at baseline, at 6-months (immediately post-intervention) and at 9 months (3 months post-intervention) on a number measures. Participatory Video intervention acceptability will be assessed through the Client Satisfaction Questionnaire and qualitative interviews, feasibility will be assessed through recruitment, consent and completion rates, and efficacy will be assessed on measures of symptoms, functioning, subjective recovery, metacognitive capacity and narrative development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participatory Video Intervention Group | Experimental | Behavioral: Participatory Video Intervention for Early PsychosisThe Participatory Video intervention consists of 12 semi-structured, 2 hour group workshops over the course of a 6-month time period. Through facilitated discussion, participants will learn how to effectively work collaboratively as a member of the video production team. Together, they will choose what story of their shared experience with psychosis they would like to tell through documentary-video and how they plan to share it. Participants will be trained to operate all equipment required to bring their vision to life. Individuals will also have the opportunity, during the Participatory Video process, to create and share their own video clips, independent of the group, allowing participants to share their own video-narrative with others (friends, family members, public) as a means of engaging in dialogue around their personal experience with psychosis. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participants will be current outpatients of the Prevention and Early intervention Program for Psychoses (PEPP) at LHSC.
- PEPP only accepts patients with a first onset primary psychotic illness that have not been treated with an antipsychotic for longer than one month.
- Study participants must be within their first 3 years of being accepted into PEPP.
- Participants must be fluent in English, as determined by referring clinicians or researchers (in the case of advertisement referred participants) in order to meaningfully participate in the PV intervention and complete the assessment tools.
Key exclusion criteria (3 listed)
- Potential participants that show high levels of disorganized or disruptive behaviour (as determined by a cut off score of 4 or 5 on the Positive Formal
- Thought Disorder or Bizarre Behaviour items of the Scale for the Assessment of Positive Symptoms [SAPS]) such that they will not be able to meaningfully participate in the MAC intervention will be excluded from the study.
- Participants must not be simultaneously participating in any other research projects involving active interventions at PEPP.
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 |
|---|---|---|
| Participatory Video Intervention for Early PsychosisThe Participatory Video intervention consists of 12 semi-structured, 2 hour group workshops over the course of a 6-month time period. Through facilitated discussion, participants will learn how to effectively work collaboratively as a member of the video production team. Together, they will choose what story of their shared experience with psychosis they would like to tell through documentary-video and how they plan to share it. Participants will be trained to operate all equipment required to bring their vision to life. Individuals will also have the opportunity, during the Participatory Video process, to create and share their own video clips, independent of the group, allowing participants to share their own video-narrative with others (friends, family members, public) as a means of engaging in dialogue around their personal experience with psychosis. | Behavioural | Participatory Video Intervention Group |
Primary outcome
Scale for Assessment of Positive Symptoms (SAPS)
Time frame: Baseline, Change from Baseline in SAPS at 6 months, change from baseline in SAPS at 9 months
Scale for Assessment of Negative Symptoms (SANS)
Time frame: Baseline, Change from Baseline in SANS at 6 months, change from baseline in SANS at 9 months
Rosenberg Self-Esteem Schedule (RSES)
Time frame: Baseline, Change from Baseline in RSES at 6 months, change from baseline in RSES at 9 months
Self-stigma of Mental Illness Scale (SSMIS)
Time frame: Baseline, Change from Baseline in SSMIS at 6 months, change from baseline in SSMIS at 9 months
The Beck Hopelessness Scale (BHS)
Time frame: Baseline, Change from Baseline in BHS at 6 months, change from baseline in BHS at 9 months
Maryland Assessment of Recovery in People with Serious Mental Illness Scale (MARS)
Time frame: Baseline, Change from Baseline in MARS at 6 months, change from baseline in MARS at 9 months
Social Functioning Scale (SFS)
Time frame: Baseline, Change from Baseline in SFS at 6 months, change from baseline in SFS at 9 months
Profile of Mood States (POMS)
Time frame: Baseline, Change from Baseline in POMS at 6 months, change from baseline in POMS at 9 months
Client Satisfaction Questionnaire-8
Time frame: at 6 months (only to those in the Participatory Video Intervention Group)
Scale to Assess Narrative Development (STAND)
Time frame: at 6 months
Metacognition Assessment Scale-Abbreviated (MAS-A)
Time frame: at 6 months
Qualitative Focus Group - Participant descriptions of their experience with Participatory Video and suggestions for how to improve the Participatory Video intervention
Time frame: at 6 months (only for those in the Participatory Video intervention group)
Individual Semi-Structured Interviews - Participant description of their individual experience with the PV intervention group and any changes they feel it may have engendered in their life
Time frame: at 9 months (only for those in the Participatory Video-intervention group)
Recruitment Rates
Time frame: baseline
Consent Rates
Time frame: baseline
Completion Rates
Time frame: at 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Background: PubMed 16611421France CM, Uhlin BD. Narrative as an outcome domain in psychosis. Psychol Psychother. 2006 Mar;79(Pt 1):53-67. doi: 10.1348/147608305X41001.
- Background: PubMed 23674667Roe D, Davidson L. Self and narrative in schizophrenia: time to author a new story. Med Humanit. 2005 Dec;31(2):89-94. doi: 10.1136/jmh.2005.000214.
- Background: PubMed 16973785Chadwick PK. Peer-professional first-person account: schizophrenia from the inside--phenomenology and the integration of causes and meanings. Schizophr Bull. 2007 Jan;33(1):166-73. doi: 10.1093/schbul/sbl034. Epub 2006 Sep 14.
- BackgroundLysaker PH, Buck KD, Ringer J. The recovery of metacognitive capacity in schizophrenia across 32 months of individual psychotherapy: A case study. Psychotherapy Research 17(6): 713-720, 2007.
- Background: PubMed 22532125Windell D, Norman RM. A qualitative analysis of influences on recovery following a first episode of psychosis. Int J Soc Psychiatry. 2013 Aug;59(5):493-500. doi: 10.1177/0020764012443751. Epub 2012 Apr 24.
- BackgroundMcAdams DP, McLean KC. Narrative identity. Current Directions in Psychological Science 22(3): 233-238, 2013.
- Background: PubMed 21956043Cavelti M, Kvrgic S, Beck EM, Rusch N, Vauth R. Self-stigma and its relationship with insight, demoralization, and clinical outcome among people with schizophrenia spectrum disorders. Compr Psychiatry. 2012 Jul;53(5):468-79. doi: 10.1016/j.comppsych.2011.08.001. Epub 2011 Sep 28.
- BackgroundGreben M, Schweitzer RD, Bargenquast R. Mechanisms of change in psychotherapy for people diagnosed with schizophrenia: the role of narrative reflexivity in promoting recovery. The Australian Journal of Rehabilitation Counselling 20(1): 1-14, 2014.
- Background: PubMed 24114797Roe D, Hasson-Ohayon I, Mashiach-Eizenberg M, Derhy O, Lysaker PH, Yanos PT. Narrative enhancement and cognitive therapy (NECT) effectiveness: a quasi-experimental study. J Clin Psychol. 2014 Apr;70(4):303-12. doi: 10.1002/jclp.22050. Epub 2013 Oct 2.
- BackgroundWhite SA. (2003). Participatory video: Images that transform and empower. Sage.
- BackgroundYang KH. (2012). Reflexivity, participation, and video. The handbook of participatory video, 100-114.
- BackgroundShaw J, Robertson C. (1997). Participatory video: a practical approach to using video creatively in group development work. London (ua): Routledge.
- Cannabis and PsychosisLink provided by the sponsor.
- 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.
Arlene MacDougall, M.Sc., M.D. principal investigator
London Health Sciences Centre/University of Western Ontario
Questions about this trial
What is this clinical trial studying?
A study testing Participatory Video Intervention for Early Psychosis in people with Psychotic Disorders and Schizophrenia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 4 inclusion and 3 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Scale for Assessment of Positive Symptoms (SAPS) (time frame: Baseline, Change from Baseline in SAPS at 6 months, change from baseline in SAPS at 9 months). The study lists 16 primary outcomes in all. 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 NCT02360566, which also lists 16 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 11 Sep 2017.