NCT02896894

Brief Summary

This is a mixed methods study that evaluates the effectiveness of the Big White Wall (BWW) online community and its implementation in 3 hospital/health system sites across Ontario. The 6 month study includes 1000 participants that are randomized to an immediate treatment group or a delayed treatment group. The primary outcome includes a change in total and subscale scores on the Recovery Assessment Scale. Qualitative interviews with various stakeholders will explore issues relating to successful implementation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
975

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

August 31, 2016

Last Update Submit

September 12, 2017

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (1)

  • Recovery Assessment Scale - Revised

    Mental health recovery, outcome is total score.

    3 months

Secondary Outcomes (6)

  • PHQ-9

    3 months

  • GAD-7

    3 months

  • Community Integration Questionnaire (CIQ)

    3 months

  • EQ-5D-5L- 5 dimension score

    3 months

  • EQ-5D-5L - VAS

    3 months

  • +1 more secondary outcomes

Other Outcomes (14)

  • Adapted Client Service Receipt Inventory (CSRI)

    3 months and 6 months (ITG)

  • Utilization of BWW

    3 Months (ITG) and 6 months (DTG)

  • Emergency room visits

    3 months and 6 months (ITG)

  • +11 more other outcomes

Study Arms (4)

Immediate Treatment Group

EXPERIMENTAL

The Immediate Treatment Group will receive access to the study intervention - the Big White Wall, immediately after consenting for a total duration of 3 months.

Other: Big White Wall (BWW)

Delayed Treatment Group

OTHER

The Delayed Treatment Group will have no access to the study intervention - the Big White Wall for the first 3 months, then receive access to the BWW for 3 consecutive months.

Other: Big White Wall (BWW)

Immediate Treatment Group - Extension

EXPERIMENTAL

Immediate Treatment Group participants who opt in to the nested study and are randomized to the The Immediate Treatment Group - Extension, will receive access to the Big White Wall for an additional 3 months (months 4-6), immediately after receiving the initial 3 months of access.

Other: Big White Wall (BWW)

Immediate Treatment Group - No Extension

NO INTERVENTION

Immediate Treatment Group participants who opt in to the nested study and are randomized to The Immediate Treatment Group - No extension, will not receive extended access to the Big White Wall.

Interventions

Big White Wall (BWW)OTHER

The BWW is an internet-based intervention that incorporates several elements of mental health care that have been shown to be effective, in a virtual environment that provides anonymity (see www.bigwhitewall.com). The on-line portal gives users access to self-assessment tools to track symptoms for a wide range of conditions over time, educational materials, a social network that allows communication between people who may have similar problems, and access to on-line courses. The service is monitored at all times by "Wall Guides" to ensure that users are responded to and that the content posted is appropriate and safe.

Delayed Treatment GroupImmediate Treatment GroupImmediate Treatment Group - Extension

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • or older
  • Referred or assessed for a mental health problem (any diagnosis may be considered, but main target is individuals with mood or anxiety symptoms and related difficulties)
  • Able to provide informed consent
  • Willing and able to access an on-line mental health intervention
  • Has or is willing to obtain and use an email address (the study can support participants to get access to an email address if needed)
  • Able to read English
  • Able to navigate an on-line tool independently or with minimal assistance
  • If relevant:
  • Being discharged from the emergency department (ED) or prompt care clinic
  • Clinician assessing patient feels the BWW may be useful (applies to ED and prompt care)

You may not qualify if:

  • \. Symptoms or behaviours that the assessing clinician feels may be disruptive or negatively impactful for the individual or others on the BWW

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (3)

  • Hensel JM, Shaw J, Ivers NM, Desveaux L, Vigod SN, Cohen A, Onabajo N, Agarwal P, Mukerji G, Yang R, Nguyen M, Bouck Z, Wong I, Jeffs L, Jamieson T, Bhatia RS. A Web-Based Mental Health Platform for Individuals Seeking Specialized Mental Health Care Services: Multicenter Pragmatic Randomized Controlled Trial. J Med Internet Res. 2019 Jun 4;21(6):e10838. doi: 10.2196/10838.

    PMID: 31165710DERIVED

  • Hensel JM, Shaw J, Ivers NM, Desveaux L, Vigod SN, Bouck Z, Onabajo N, Agarwal P, Mukerji G, Yang R, Nguyen M, Jeffs L, Jamieson T, Bhatia RS. Extending access to a web-based mental health intervention: who wants more, what happens to use over time, and is it helpful? Results of a concealed, randomized controlled extension study. BMC Psychiatry. 2019 Jan 24;19(1):39. doi: 10.1186/s12888-019-2030-x.

    PMID: 30678676DERIVED

  • Hensel JM, Shaw J, Jeffs L, Ivers NM, Desveaux L, Cohen A, Agarwal P, Wodchis WP, Tepper J, Larsen D, McGahan A, Cram P, Mukerji G, Mamdani M, Yang R, Wong I, Onabajo N, Jamieson T, Bhatia RS. A pragmatic randomized control trial and realist evaluation on the implementation and effectiveness of an internet application to support self-management among individuals seeking specialized mental health care: a study protocol. BMC Psychiatry. 2016 Oct 18;16(1):350. doi: 10.1186/s12888-016-1057-5.

    PMID: 27756281DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Sacha Bhatia, MD, FRCP(C)

    Women's College Hospital Institute for Health System Solutions and Virtual Care (WIHV)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 12, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

There are agreements in place to share individual participant data between all the study sites and Women's College Hospital.

Locations

CA(1)