A Pilot Randomized Controlled Trial to Test Effectiveness of the ACE4 (Activity Challenge - 4 Areas) for Depression and Anxiety: A Behavioural Activation Based Game.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The Hospital Anxiety and Depression Scale (HAD)
研究概览
简要总结
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.
详细描述
INTRODUCTION:
Behavioral activation (BA) is an evidence based intervention that has been found to be effective in treating depression (ref). It has the advantage of being low cost and can be used by people with low literacy. BA can be easily delivered in low and middle income countries like Pakistan, if appropriately adapted.
We have developed 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. This is a pilot study using a RCT design to test the effectiveness of this game.
Objective To assess effectiveness of ACE4, for depression against care as usual. Study design and duration This study is a Randomized Controlled Trial (RCT) which aims to assess effectiveness of ACE4 against care as usual for depression. Study participants will be randomly assigned to two groups the intervention group will receive ACE4 and TAU, while the control group will receive only TAU.
ACE4: Introduction Intervention focuses on behavioral activation. Although ACE4 is a single player game, it can be facilitated by a carer. The game comes with 15 cards in four colour, with each colour representative of an activity area (for example, Creative activities, recreational, self care and work, social and spiritual activities). The idea is to choose equal number of activities from each colour. Every card has a number. Patients have to write this number on activity calendar that comes with this game, along with the time activity was performed. The aim of the game is to score maximum points at the end of the 6 weeks. Those with scores in high range get ACE4 badge (in addition to getting an improvement in their mood)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The Hospital Anxiety and Depression Scale (HAD)
时间窗: At the base line and then at the end of therapy (8 weeks).
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).
次要结局
- 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).)
研究者
Dr. Farooq Naeem
Principal Investigator
Queen's University