Internet-delivered CBM-C for OC-symptoms

NCT ID: NCT04575805

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-03-01

Brief Summary

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A factorial randomised controlled trial comparing internet-delivered combined cognitive bias modification intervention (iCBM-C) versus internet-delivered CBM-interpretation intervention (iCBM-I), internet-delivered CBM-attention intervention (iCBM-A) and wait-list control on obsessive-compulsive (OC) symptoms, OC-beliefs, OC-related interpretation and attention biases

Detailed Description

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Cognitive behavioral therapy, consisting of exposure and response prevention and cognitive restructuring, is still one of the most effective treatments for obsessive compulsive disorder. However, some patients do not fully benefit from the treatment. This condition results in more search for novel approaches that can contribute to effectiveness of standard treatments. In this regard, the use of technology-based methods in recent researches is noteworthy. Cognitive bias modification (CBM) is one of these current efforts of technology-based methods. CBM involves computerized tasks designed to modify some cognitive biases such as attention and interpretation associated with psychopathology, particularly anxiety disorders. Researches have generally demonstrated that cognitive bias modification can be effective way to alter cognitive biases and to reduce anxiety symptoms. In recent years, there have been also some studies to investigate the potential effects of cognitive bias modification for obsessive compulsive disorder.The results of both CBM-Interpretation (CBM-I) and CBM-Attention (CBM-A) studies have shown that it is an effective and promising method in reducing cognitive biases in obsessive compulsive disorder (OCD). Although these studies are highly informative, they do not provide information about the causal role one bias has during the operation of another. In recent years, there has been a growing consensus that both biases arise from the same system, thereby, it is possible that modifying the system to alter one bias (e.g., attention), will also impact on the presence of the other bias.). In line with this notion, there are a couple of studies to test the effect of Combined Cognitive Bias Modification (CBM-C) which is combination of both CBM-A and CBM-I in intervention programs. The results of these studies are generally very positive. Although it is well established that attention bias and interpretation bias each have a key role in the development and maintenance of OCD, only one bias is targeted in CBM studies of OCD. Considering that a "combined cognitive bias" may contribute to the maintenance of several disorders, in order to try to maximise the potential clinical impact, the present research aims at exploring whether the combination of the CBM-A and CBM-I procedures would be more effective in reducing cognitive biases and OC symptoms than either alone. It is expected that internet-delivered CBM-C (iCBM-C) will result in superior treatment outcomes as indexed by internet-delivered CBM-I intervention only (iCBM-I), internet-delivered CBM-A intervention only (iCBM-A), and wait-list control (WLC).

Conditions

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Obsessive-compulsive Disorders and Symptoms Obsessive Thoughts Obsessive Compulsive Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Factor 1: Cognitive Bias Modification-Interpretation (yes or no)

Factor 2: Cognitive Bias Modification-Attention (yes or no)

Each participant will be randomized to one of four conditions:

Condition 1: Cognitive Bias Modification-Interpretation and Cognitive Bias Modification-Attention

Condition 2: Cognitive Bias Modification-Interpretation and No Cognitive Bias Modification-Attention

Condition 3: No Cognitive Bias Modification-Interpretation and Cognitive Bias Modification-Attention

Condition 4: No Cognitive Bias Modification-Interpretation and No Attention Bias Modification-Attention
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Internet-delivered Combined Cognitive Bias Modification

CBM Version 1 is the combination of internet-delivered Cognitive Bias Modification-Interpretation and internet-delivered Cognitive Bias Modification-Attention interventions taking place over 4 weeks (eight sessions, twice per week).

Group Type EXPERIMENTAL

Internet-delivered Combined Cognitive Bias Modification (iCBM-C)

Intervention Type BEHAVIORAL

The iCBM-C is online CBM intervention which is the combination of iCBM-I and iCBM-A interventions for obsessive-compulsive symptoms delivered in eight sessions, twice per week for 4 weeks. The presentation order of the two intervention components will be counterbalanced to allow exploration of any order effects. Thereby, half of the participants in iCBM-C group will complete the iCBM-A task followed by iCBM-I, while the other half will complete the iCBM-I task followed by iCBM-A during each session.

Internet-delivered Cognitive Bias Modification-Interpretation

CBM Version 2 is an internet-delivered Cognitive Bias Modification-Interpretation intervention taking place over 4 weeks (eight sessions, twice per week).

Group Type EXPERIMENTAL

Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I)

Intervention Type BEHAVIORAL

The iCBM-I is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of OCD related scenarios taking place over eight sessions, twice per week for 4 weeks.

Internet-delivered Cognitive Bias Modification-Attention

CBM Version 3 is an internet-delivered Cognitive Bias Modification-Attention intervention taking place over 4 weeks (eight sessions, twice per week).

Group Type EXPERIMENTAL

Internet-delivered Cognitive Bias Modification-Attention (iCBM-A)

Intervention Type BEHAVIORAL

The iCBM-A is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of the modified dot-probe task taking place over eight sessions, twice per week for 4 weeks.

Wait-List Control

This arm is wait-list control group which will also receive internet-delivered Combined Cognitive Bias Modification intervention after the follow-up assessment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet-delivered Combined Cognitive Bias Modification (iCBM-C)

The iCBM-C is online CBM intervention which is the combination of iCBM-I and iCBM-A interventions for obsessive-compulsive symptoms delivered in eight sessions, twice per week for 4 weeks. The presentation order of the two intervention components will be counterbalanced to allow exploration of any order effects. Thereby, half of the participants in iCBM-C group will complete the iCBM-A task followed by iCBM-I, while the other half will complete the iCBM-I task followed by iCBM-A during each session.

Intervention Type BEHAVIORAL

Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I)

The iCBM-I is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of OCD related scenarios taking place over eight sessions, twice per week for 4 weeks.

Intervention Type BEHAVIORAL

Internet-delivered Cognitive Bias Modification-Attention (iCBM-A)

The iCBM-A is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of the modified dot-probe task taking place over eight sessions, twice per week for 4 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Fluent in written and spoken Turkish
* Daily access to the internet by computer
* No participation on any other interventional study or clinical trial
* The presence of high obsessive compulsive symptoms (Turkish version of Padua Inventory-Washington State University Revision scores \> 65.81).

Exclusion Criteria

* The absence of high obsessive compulsive symptoms (Turkish version of Padua Inventory-Washington State University Revision scores \< 65.81)
* Suicidal ideation and severe psychotic symptoms (a rating of slight (i.e., 1) or greater on any item within the domain based on their responses to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version
* No access to the internet and computer
* Color blindness
* A current diagnosis of neurological and psychiatric disorder
* Ongoing psychological/psychiatric treatment
* Ongoing participation in other interventional study or clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Sıla Derin, MA

Cilinical Psychologist, MA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sıla Derin, MA

Role: STUDY_CHAIR

Dokuz Eylul University

Locations

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Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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120K044

Identifier Type: -

Identifier Source: org_study_id

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