Trials / Recruiting
RecruitingNCT06941155
Gamified Combined Cognitive Bias Modification in Adults Diagnosed With OCD: Randomized Controlled Trial
A Randomized Controlled Trial on the Effects of Mobile-Based Gamified Combined Cognitive Bias Modification on OCD Symptoms, Obsessive Beliefs, Cognitive Biases, Depressive Symptoms and Distress in Adults Diagnosed With OCD
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Dokuz Eylul University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This randomized controlled trial examines the effects of a mobile-based gamified combined cognitive bias modification (CBM-C) intervention on obsessive-compulsive symptoms, obsessive beliefs, attentional and interpretation biases, depressive symptoms, and psychological distress. The gamified CBM-C condition is compared to a standard mobile-based CBM-C and a placebo control condition. All interventions are delivered via a mobile application. Assessments are conducted at baseline, post-intervention (week 4), and 3-month follow-up.
Detailed description
Cognitive Bias Modification (CBM) is a cognitive intervention that experimentally modifies cognitive biases by using a series of disorder-related stimuli designed to manipulate cognitive processes relevant to psychopathology. There are two major forms of CBM interventions: Cognitive Bias Modification-Attention (CBM-A) and Cognitive Bias Modification-Interpretation (CBM-I). CBM is also a promising treatment for Obsessive- Compulsive Disorder (OCD). In recent years, there has been a growing consensus that there may be causal relations among different cognitive biases ("combined cognitive bias hypothesis"). In line with this hypothesis, it is reasonable to suggest that modification in one section will also have an impact on other biases. There are a few studies testing the effect of Combined CBM (CBM-C) programs on anxiety symptoms, depressive symptoms, and OCD symptoms in subclinical samples with promising results. In recent years, gamification has also been used in order to increase motivation and participation in experimental tasks that constitute the content of both CBM-A and CBM-I interventions. It is possible to see examples of this method in the field of mental health in general and it is stated that it has the potential to be effective as an intervention on reducing the symptoms of psychiatric disorders. However, there is no study to investigate the effect of gamified CBM in individuals with OCD. Based on these new developments and their positive effects, the aim of the study is to investigate the effect of the gamified CBM-C on reducing the severity of OCD symptoms, obsessive beliefs, interpretation and attentional biases, depressive symptoms, and psychological distress, and increasing motivation and participation in experimental tasks. The study will be conducted on adult participants primarily diagnosed with OCD according to the DSM-5 criteria by a psychiatrist at Dokuz Eylul University Hospital and referred for outpatient treatment at the same hospital. Participants will be randomly assigned to one of three groups: gamified CBM-C, standard CBM-C, or a placebo control condition. The intervention will be delivered via a mobile phone. Data collection will include self-report assessments and behavioral tasks. Attentional bias will be measured using a dot-probe task with eye-tracking, and interpretation bias will be assessed through a recognition scenario task. Measurements will be taken at baseline, post-intervention (week 4), and at 3-month follow-up. It is expected that participants in the gamified CBM-C condition will demonstrate greater improvements across clinical symptoms, cognitive biases, and motivational outcomes compared to participants in the standard CBM-C and placebo control groups. To the best of current knowledge, this study will be the first to evaluate the effects of a gamified CBM-C intervention in individuals diagnosed with OCD. Its findings are anticipated to contribute to the development of scalable, accessible, and cost-effective digital interventions for clinical populations with elevated dropout and relapse rates.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Gamified-Combined Cognitive Bias Modification | A gamified version of the combined cognitive bias modification (CBM-C) intervention, which includes both attention and interpretation bias modification tasks. The attention component is a modified dot-probe task, and the interpretation component consists of OCD-related scenarios with word-completion exercises. Gamification elements such as feedback and visual rewards are embedded to enhance motivation and engagement. The presentation order of the two intervention components will be counterbalanced: half of the participants will receive the attention bias task first followed by the interpretation task; the other half will receive the interpretation task first followed by the attention bias task. The intervention is delivered via mobile phone in eight sessions over four weeks (two sessions per week). |
| BEHAVIORAL | Standard Combined Cognitive Bias Modification | A standard version of the combined cognitive bias modification (CBM-C) intervention, consisting of attention and interpretation bias tasks without gamification features. The attention task is a modified dot-probe paradigm, and the interpretation task involves OCD-related scenarios followed by word-completion exercises. The presentation order of the two intervention components will be counterbalanced: half of the participants will receive the attention bias task first followed by the interpretation task; the other half will receive the interpretation task first followed by the attention bias task. The intervention is delivered via mobile phone in eight sessions over four weeks (two sessions per week). |
| BEHAVIORAL | Placebo | A placebo version of the standard CBM-C intervention that retains the same structure and timing but omits all active bias modification elements. The attention task (modified dot-probe) presents probes equally behind threat and neutral stimuli, and the interpretation task includes OCD-related scenarios with word-completion items that lead to neutral outcomes. No manipulations are applied to shift cognitive bias. The presentation order of the two intervention components will be counterbalanced: half of the participants will receive the attention bias task first followed by the interpretation task; the other half will receive the interpretation task first followed by the attention bias task. The intervention is delivered via mobile phone in eight sessions over four weeks (two sessions per week). |
Timeline
- Start date
- 2025-05-14
- Primary completion
- 2027-04-02
- Completion
- 2027-04-02
- First posted
- 2025-04-23
- Last updated
- 2025-05-15
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06941155. Inclusion in this directory is not an endorsement.