Overview

This trial is active, not recruiting.

Conditions psychotic disorders, schizophrenia
Treatment participatory video intervention for early psychosis
Sponsor Lawson Health Research Institute
Collaborator ProjectVideo Inc.
Start date January 2016
End date December 2016
Trial size 10 participants
Trial identifier NCT02360566, 8211

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
participatory video intervention for early psychosis
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.

Primary Outcomes

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
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

Eligibility Criteria

Male or female participants from 16 years up to 25 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Additional Information

Official title The Novel Use of Participatory Video as a Recovery-Oriented Intervention in Early Psychosis: A Pilot Study
Principal investigator Arlene MacDougall, M.Sc., M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.