NCT02536924

Brief Summary

Crisis Teams are now a well established part of the mental health system. These teams are effective in providing crisis management, treatment, referral, and educational services. We are testing a waiting room intervention for the patients attending a Crisis Team. As far as we are aware, no trial of a waiting room intervention has been reported in a psychiatric setting. This is a preliminary study using a Randomized Control Trial (RCT) Design. Patients (N =40) will be randomly allocated to either the treatment or the control group, and will be selected from the local Crisis Team. The treatment group will receive a waiting room intervention called, RESOLVE (Relaxation, SOLving problem and cognitiVe Errors), that is a short film, Plus Treatment As Usual (TAU), and the control group will receive only TAU. Patients in both groups will be assessed before and after the intervention, using the HADS (Hospital Anxiety And Depression Scale), CORE (Clinical Outcome in Routine Evaluation), (to measure psychopathology) and WHODAS (World Health Organization Disability Assessment Schedule) (for functioning). We hypothesize that the treatment group will demonstrate significant improvement in mental health and functioning, compared to the control group. Analyses will be conducted using SPSS v22, and will consist of a t-test or Chi Square test to measure the baseline differences, and a linear regression to compare the differences between the two groups at the end of the intervention. Results will be published in international journals and will be presented in local and international conferences.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

August 29, 2015

Last Update Submit

August 29, 2015

Conditions

Depression Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Hospital Anxiety and Depression Scale (HADS)

    14 item, self assessment scale designed to measure anxiety and depression.

    6 months

Secondary Outcomes (2)

  • The Clinical Outcome in Routine Evaluation (CORE)

    6 months

  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS)

    6 months

Study Arms (2)

Waiting room intervention plus TAU

EXPERIMENTAL

The treatment group will receive waiting room intervention plus treatment as usual.

Behavioral: Waiting Room InterventionBehavioral: Treatment as usual.

Only TAU.

EXPERIMENTAL

The control group will receive only treatment as usual.

Behavioral: Treatment as usual.

Interventions

Waiting Room InterventionBEHAVIORAL

The waiting room intervention is called RESOLVE (Relaxation SOLving problem and cognitive errors), which is a short film.

Waiting room intervention plus TAU
Treatment as usual.BEHAVIORAL

The patient will receive treatment as usual.

Only TAU.Waiting room intervention plus TAU

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All those who fulfill the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4) using ICD10 RDC
  • between the ages of 18-65
  • must meet the assessment criteria at the beginning and the end of the study period

You may not qualify if:

  • excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence)
  • significant cognitive impairment (for example learning disability or dementia)
  • active psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction & Mental Health Services- Kingston Frontenac Lennox and Addington

Kingston, Ontario, K7L 1B9, Canada

RECRUITING

Related Publications (9)

  • Coyne JC, Palmer SC, Shapiro PJ, Thompson R, DeMichele A. Distress, psychiatric morbidity, and prescriptions for psychotropic medication in a breast cancer waiting room sample. Gen Hosp Psychiatry. 2004 Mar-Apr;26(2):121-8. doi: 10.1016/j.genhosppsych.2003.08.012.

    PMID: 15038929BACKGROUND

  • Evans, J. M.-C., Frank Margison, Michael Barkham, Kerry Audin, Janice Connell, Graeme McGrath, Chris. (2000). CORE: Clinical Outcomes in Routine Evaluation. Journal of Mental Health, 9(3), 247-255. http://doi.org/10.1080/jmh.9.3.247.255

    BACKGROUND

  • Holmes-Garrett, C. (1990). The Crisis of the Forgotten Family. Social Work with Groups, 12(4), 141-157. http://doi.org/10.1300/J009v12n04_09

    BACKGROUND

  • Oermann MH. Effects of educational intervention in waiting room on patient satisfaction. J Ambul Care Manage. 2003 Apr-Jun;26(2):150-8. doi: 10.1097/00004479-200304000-00007.

    PMID: 12698929BACKGROUND

  • Rhodes KV, Lauderdale DS, Stocking CB, Howes DS, Roizen MF, Levinson W. Better health while you wait: a controlled trial of a computer-based intervention for screening and health promotion in the emergency department. Ann Emerg Med. 2001 Mar;37(3):284-91. doi: 10.1067/mem.2001.110818.

    PMID: 11223765BACKGROUND

  • Scott RL. Evaluation of a mobile crisis program: effectiveness, efficiency, and consumer satisfaction. Psychiatr Serv. 2000 Sep;51(9):1153-6. doi: 10.1176/appi.ps.51.9.1153.

    PMID: 10970919BACKGROUND

  • Wheeler JG, Fair M, Simpson PM, Rowlands LA, Aitken ME, Jacobs RF. Impact of a waiting room videotape message on parent attitudes toward pediatric antibiotic use. Pediatrics. 2001 Sep;108(3):591-6. doi: 10.1542/peds.108.3.591.

    PMID: 11533323BACKGROUND

  • Zealberg JJ, Santos AB, Fisher RK. Benefits of mobile crisis programs. Hosp Community Psychiatry. 1993 Jan;44(1):16-7. doi: 10.1176/ps.44.1.16. No abstract available.

    PMID: 8436356BACKGROUND

  • Naeem F, Munshi T, Gratzer D, Rodie D, Irfan M, Rao S, Husain N, Farooq S, Sanches M, Ayub M, Lecomte T. Video intervention for the psychiatric waiting room: proof-of-concept randomised controlled trial of RESOLVE (Relaxation Exercise, SOLVing problem and cognitive Errors). BJPsych Open. 2019 Sep 6;5(5):e77. doi: 10.1192/bjo.2019.59.

    PMID: 31488227DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Farooq Naeem, MSc, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupinder Johal, MsC, pHD

CONTACT

613-544-1356rupyjohal@gmail.com

Hannah C Taalman, BSC, MSc(C)

CONTACT

613-548-5567taalmanh@providencecare.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2015

First Posted

September 1, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

CA(1)