Pilot RCT to Test Effectiveness of the ACE4 (Activity Challenge- 4 Areas) for Depression and Anxiety
A Pilot Randomized Controlled Trial to Test Effectiveness of the ACE4 (Activity Challenge - 4 Areas) for Depression and Anxiety: A Behavioural Activation Based Game.
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 29, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 2, 2015
August 1, 2015
1 year
August 29, 2015
August 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The Hospital Anxiety and Depression Scale (HAD)
A 14 item, self assessment scale designed to measure anxiety and depression. It has a high internal consistency, face validity and concurrent validity. Even-numbered questions relate to depression and odd-numbered questions relate to anxiety. Each question has 4 possible responses. Responses are scored on a scale from 3 to 0. The maximum score is therefore 21 for depression and 21 for anxiety. A score of 11 or higher indicates the probable presence of the mood disorder with a score of 8 to 10 being just suggestive of the presence of the respective state. The two subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS is now divided into four ranges: normal (0-7), mild (8-10), moderate (11-15) and severe (16-21).
At the base line and then at the end of therapy (8 weeks).
Secondary Outcomes (2)
The Clinical Outcome in Routine Evaluation (CORE)
At the base line and then at the end of therapy (8 weeks).
Brief Disability Questionnaire (BDQ)
At the base line and then at the end of therapy (8 weeks).
Study Arms (2)
ACE4 and TAU
ACTIVE COMPARATORThis group will receive ACE4 as an intervention and treatment as usual.
TAU Only
NO INTERVENTIONThis group will receive only the treatment as usual.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
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 & Addington
Kingston, Ontario, K7L 1B9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Farooq Naeem, MsC, PhD
Queen's University
Central Study Contacts
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 2, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 2, 2015
Record last verified: 2015-08