Recruiting

ACE4

Sponsor:

Queen's University

Code:

NCT02538549

Conditions

Anxiety Disorder; Mixed With Depression (Mild)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ACE4

Study Details

Brief summary:

Behavioral activation (BA) is a low cost, evidence-based intervention that can be effective in treating depression and anxiety. We have developed a behavioural activation card game for clients receiving treatment through the Crisis Team and Traditional Case Management (TCM) in Kingston, ON. The game is designed to integrate behavioural activation tools into daily life while receiving points for completion of the each Activity Challenge, which are divided into 4 areas (ACE4), with the goal to receive maximum amount of points in the timeframe of the study. Using a Randomized Control Trial (RCT) design, participants (n=40) will be assigned to one of two groups, with the intervention group receiving ACE4 and treatment as usual (TAU) and the control group only receiving TAU. Assessments will be carried out upon entry to the study and at the end of the intervention period (8 weeks). Assessments will be completed using the WHODAS 2.0 (World Health Organization Disability Assessment Schedule), HADS (The Hospital Anxiety and Depression Scale), and CORE (Clinical Outcome in Routine Evaluation). We hypothesize that the treatment group receiving the ACE4 intervention will show improvement in overall mental state. Analyses will be conducted using SPSSv16, an analysis of covariance and t-test, and a binary logistic regression analysis will be used to investigate factors that predict good outcomes. Results will be published in international journals and presented at conferences with an aim towards being applied to clinics in Pakistan.

Conditions

Anxiety Disorder; Mixed With Depression (Mild)

Study ID

NCT02538549

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:

  • Fulfill the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (based on interviews using SCAN Urdu version).
  • Between the ages of 18 to 65
  • Score 8 or more on HADS, Depression Subscale.
  • Patients will be asked to attend a further appointment at the end of study period and will be assessed again.

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

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: ACE4 and TAU

This group will receive ACE4 as an intervention and treatment as usual.

no intervention: TAU Only

This group will receive only the treatment as usual.

Interventions

ACE4

Activity Challenge 4 is a single player card game that is based on principles of behavioral activation. The game was used with crisis and transitional case management clients, with positive feedback.

Primary outcome measure

  • The Hospital Anxiety and Depression Scale (HAD) [ Time Frame: At the base line and then at the end of therapy (8 weeks). ]

Central Contacts and Locations

Locations

Addiction & Mental Health Services - Kingston Frontenac Lennox & Addington

Recruiting

Kingston, Ontario, Canada, K7L 1B9

Contacts

More Information

Sponsor

Queen's University

Last update posted

Sep 2, 2015

Last verified

Aug, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2015-09-02.