Recruiting

Resolve

Sponsor:

Queen's University

Code:

NCT02536924

Conditions

Depression Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Waiting Room Intervention

Treatment as usual.

Study Details

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.

Conditions

Depression Anxiety Disorder

Study ID

NCT02536924

Start date

Aug, 2015

Status verified date

Aug, 2015

Completion date

Aug, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Waiting room intervention plus TAU

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

experimental: Only TAU.

The control group will receive only treatment as usual.

Interventions

Waiting Room Intervention

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

Treatment as usual.

The patient will receive treatment as usual.

Primary outcome measure

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Rupinder Johal, MsC, pHD

613-544-1356rupyjohal@gmail.com

Hannah C Taalman, BSC, MSc(C)

613-548-5567taalmanh@providencecare.ca

Locations

Addiction & Mental Health Services- Kingston Frontenac Lennox and Addington

Recruiting

Kingston, Ontario, Canada, K7L 1B9

Contacts

More Information

Sponsor

Queen's University

Last update posted

Sep 1, 2015

Last verified

Aug, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Queen's University on 2015-09-01.