Gamified Combined Cognitive Bias Modification in Adults Diagnosed With OCD: Randomized Controlled Trial

NCT06941155 | Recruiting

• 1 other identifier: 223S390
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive Compulsive Disorder (OCD)

Outcome Measures

Primary Outcomes (4)

• Yale-Brown Obsessive Compulsive Scale

  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.

  Baseline, Post-Intervention (Week 4), 3-Month Follow-Up

• Obsessive Beliefs Questionnaire-44

  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).

  Baseline, Post-Intervention (Week 4), 3-Month Follow-Up

• OC bias index

  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).

  Baseline, Post-Intervention (Week 4), 3-Month Follow-Up

• Dot-Probe Task with Eye-Tracking

  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).

  Baseline, Post-Intervention (Week 4), 3-Month Follow-Up

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Feedback Form Questionnaire

  3-Month Follow-Up

Study Arms (3)

Gamified-Combined Cognitive Bias Modification

EXPERIMENTAL

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.

Behavioral: Gamified-Combined Cognitive Bias Modification

Standart Combined Cognitive Bias Modification

ACTIVE COMPARATOR

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.

Behavioral: Standard Combined Cognitive Bias Modification

Placebo Control

PLACEBO COMPARATOR

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.

Behavioral: Placebo

Interventions

Gamified-Combined Cognitive Bias Modification BEHAVIORAL

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).

Gamified-Combined Cognitive Bias Modification

Standard Combined Cognitive Bias Modification BEHAVIORAL

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).

Standart Combined Cognitive Bias Modification

Placebo BEHAVIORAL

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).

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Dokuz Eylul University Hospital

Izmir, 35340, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Sıla Derin, PhD

  Dokuz Eylul University, İzmir, Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sıla Derin, PhD

CONTACT

+905543366293; siladerin@gmail.com

Orçun Yorulmaz, Prof. Dr.

CONTACT

+905068620350; orcun.yorulmaz@deu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cilinical Psychologist, PhD

Model Details: Participants will be randomly assigned to one of three parallel groups: (1) gamified cognitive bias modification-combined (CBM-C), (2) standard CBM-C, or (3) placebo control. Each group will receive only one type of intervention throughout the study period. Interventions will be delivered independently and simultaneously via mobile phone, and there will be no crossover between conditions.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): April 2, 2027
• Study Completion (Estimated): April 2, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)