Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder; Mixed With Depression (Mild) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACE4 | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ACE4 and TAU
- description
- This group will receive ACE4 as an intervention and treatment as usual.
- interventionNames
- Behavioral: ACE4
- type
- NO_INTERVENTION
- label
- TAU Only
- description
- This group will receive only the treatment as usual.
Primary outcomes (1)
- measure
- The Hospital Anxiety and Depression Scale (HAD)
- timeFrame
- At the base line and then at the end of therapy (8 weeks).
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available