Internet-delivered CBM-C for OC-symptoms

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Obsessive Compulsive Behavior; Obsessive-compulsive Disorders and Symptoms; Obsessive Thoughts

Treatments: Behavioral: Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I); Behavioral: Internet-delivered Combined Cognitive Bias Modification (iCBM-C); Behavioral: Internet-delivered Cognitive Bias Modification-Attention (iCBM-A)

Study type: Interventional

Funder types: Other

Identifiers

NCT04575805

120K044

Details and patient eligibility

About

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

Full description

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).

Enrollment: 94 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

94 participants in 4 patient groups

Internet-delivered Combined Cognitive Bias Modification

Experimental group

Description:

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).

Treatment:

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

Internet-delivered Cognitive Bias Modification-Interpretation

Experimental group

Description:

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

Treatment:

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

Internet-delivered Cognitive Bias Modification-Attention

Experimental group

Description:

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

Treatment:

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

Wait-List Control

No Intervention group

Description:

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