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RCT of RESOLVE: A Waiting Room Intervention for Crisis Clients (RESOLVE)

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ClinicalTrials.gov Identifier: NCT02536924
Recruitment Status : Unknown
Verified August 2015 by Dr. Farooq Naeem, Queen's University.
Recruitment status was:  Recruiting
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Farooq Naeem, Queen's University

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Disorder Behavioral: Waiting Room Intervention Behavioral: Treatment as usual. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Randomized Control Trial of RESOLVE (Relaxation Exercise, SOLving Problem and cognitiVe Errors): A Waiting Room Intervention for Crisis Clients
Study Start Date : August 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Waiting room intervention plus TAU
The treatment group will receive waiting room intervention plus treatment as usual.
Behavioral: Waiting Room Intervention
The waiting room intervention is called RESOLVE (Relaxation SOLving problem and cognitive errors), which is a short film.

Behavioral: Treatment as usual.
The patient will receive treatment as usual.

Experimental: Only TAU.
The control group will receive only treatment as usual.
Behavioral: Treatment as usual.
The patient will receive treatment as usual.




Primary Outcome Measures :
  1. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 months ]
    14 item, self assessment scale designed to measure anxiety and depression.


Secondary Outcome Measures :
  1. The Clinical Outcome in Routine Evaluation (CORE) [ Time Frame: 6 months ]
    A client self-report questionnaire designed to be administered before and after therapy.

  2. World Health Organization Disability Assessment Schedule 2.0 (WHODAS) [ Time Frame: 6 months ]
    A client self-report questionnaire designed to be administered before and after therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536924


Contacts
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Contact: Rupinder Johal, MsC, pHD 613-544-1356 rupyjohal@gmail.com
Contact: Hannah C Taalman, BSC, MSc(C) 613-548-5567 ext 1285 taalmanh@providencecare.ca

Locations
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Canada, Ontario
Addiction & Mental Health Services- Kingston Frontenac Lennox and Addington Recruiting
Kingston, Ontario, Canada, K7L 1B9
Contact: Rupy Johal    613-544-1356    rupyjohal79@gmail.com   
Contact: Farooq Naeem, MSc, PhD    613-544-1356    farooqnaeem7@gmail.com   
Sub-Investigator: Hannah Taalman, BSc         
Sub-Investigator: Danielle Goldberg, BScN         
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: Farooq Naeem, MSc, PhD Queen's University
Publications:
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
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
Oermann. (n.d.). Effects of Educational Intervention in Waiting Room on Patie... : The Journal of Ambulatory Care Management. Retrieved March 30, 2015, from http://journals.lww.com/ambulatorycaremanagement/Fulltext/2003/04000/Effects_of_Educational_Intervention_in_Waiting.7.aspx

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Farooq Naeem, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT02536924    
Other Study ID Numbers: 6015290
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders