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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Yale-Brown Obsessive Compulsive Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participants will know that they will receive a treatment, but they will be blinded to randomization, i.e. will not know which groups they can be randomized to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Primary diagnosis of obsessive-compulsive disorder (OCD), confirmed by a licensed clinician using the Structured Clinical Interview for DSM-5 (SCID-5)
- •No current suicidal ideation or psychotic symptoms
- •Access to the internet and a mobile phone
- •Stable psychiatric medication use for at least one month prior to enrollment, with no changes in dosage during the 4-week intervention period
- •No current neurological or medical condition that would interfere with participation
- •Ability to perceive colored visual stimuli (e.g., no color blindness)
- •Not currently enrolled in another intervention-based study
- •Not receiving any other form of psychological treatment at the time of participation
排除标准
- •Presence of active suicidal ideation or psychotic symptoms
- •Unstable psychiatric medication use (e.g., recent dose change within the past month or expected change during the intervention period)
- •Significant neurological or medical illness that may interfere with participation
- •Visual impairments that would prevent accurate perception of colored stimuli (e.g., color blindness)
- •Current participation in another clinical trial involving psychological intervention
- •Receiving concurrent psychotherapy or other psychological treatments outside of the study
研究组 & 干预措施
Gamified-Combined Cognitive Bias Modification
Participants in this group will receive the gamified version of the combined cognitive bias modification (CBM-C) intervention, consisting of eight sessions over four weeks (two sessions per week), delivered via mobile phone. The intervention includes both attention and interpretation bias modification tasks enhanced with gamification elements.
干预措施: Gamified-Combined Cognitive Bias Modification (Behavioral)
Standart Combined Cognitive Bias Modification
Participants in this group will receive the standard version of the combined cognitive bias modification (CBM-C) intervention, consisting of eight sessions over four weeks (two sessions per week), delivered via mobile phone. The intervention includes both attention and interpretation bias modification tasks, without any gamification features.
干预措施: Standard Combined Cognitive Bias Modification (Behavioral)
Placebo Control
Participants in this group will receive a placebo version of the standard combined cognitive bias modification (CBM-C) intervention, consisting of eight sessions over four weeks (two sessions per week), delivered via mobile phone. The placebo version retains the structure of the standard intervention but does not include any active bias modification components.
干预措施: Placebo (Behavioral)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale
时间窗: Baseline, Post-Intervention (Week 4), 3-Month Follow-Up
This clinician-administered measure is used to assess the severity of obsessive-compulsive symptoms. It includes 19 items in total; however, only the first 10 items are used to calculate the total score. Each item is rated on a 0 to 4 scale, resulting in a total score range of 0 to 40. Higher scores indicate greater symptom severity (worse outcome).The measure is conducted through a semi-structured clinical interview.
Obsessive Beliefs Questionnaire-44
时间窗: Baseline, Post-Intervention (Week 4), 3-Month Follow-Up
This self-report measure is used to assess dysfunctional beliefs commonly associated with obsessive-compulsive symptoms. It consists of 44 items rated on a Likert-type scale ranging from 1 to 7. The total score ranges from 44 to 308. Higher scores indicate that the individual has more maladaptive obsessive-compulsive beliefs (worse outcome).
OC bias index
时间窗: Baseline, Post-Intervention (Week 4), 3-Month Follow-Up
Measure of interpretation biases. It is a computerized task that requires participants to read and imagine themselves in 10 OC-relevant test scenarios and 10 non-OC-relevant scenarios with a title and missing letter in the final word of the sentence. Participants are then provided with a recognition rating form where they see the title of only the 10 OC-relevant scenarios in which they had previously imagined themselves. Each title corresponds with four different interpretations: target bias (OC-positive and OC-negative), and foil bias (foil-positive and foil-negative). Participants are asked to rate (on a 4-point scale) each sentence independently in terms of how similar each interpretation option is to the meaning of the scenario they had previously read. Target and Foil Bias Index scores are calculated by subtracting ratings for negative items from ratings for positive items. A positive score indicates that the individual has more OC-positive interpretations (better outcome).
Dot-Probe Task with Eye-Tracking
时间窗: Baseline, Post-Intervention (Week 4), 3-Month Follow-Up
A computerized task measuring attention bias using 48 trials combining probe type, position, and image type (neutral vs. OCD-related). Each trial includes a fixation cross (500 ms), a picture pair (1500 ms), and a directional probe replacing one image. Participants respond via keyboard; bias scores are calculated by subtracting response times for probes replacing OCD-related vs. neutral images. More negative bias scores indicate reduced attention to OCD-related stimuli (better outcome). Eye-tracking (Gazepoint HD 150Hz) measures (a) vigilance: first fixation latency and frequency (including direction bias), (b) disengagement: first fixation duration, and (c) sustained attention: total fixation count and duration. Post-assessment reductions in early, frequent, or prolonged fixations on OCD-related stimuli compared to baseline are interpreted as improved attentional control (better outcome).
次要结局
- Hamilton Depression Rating Scale(Baseline, Post-Intervention (Week 4), 3-Month Follow-Up)
- Kessler Psychological Distress Scale(Baseline, Post-Intervention (Week 4), 3-Month Follow-Up)
研究者
Sıla Derin, PhD
Cilinical Psychologist, PhD
Dokuz Eylul University