Internet-delivered CBM-C for OC-symptoms

NCT04575805 | Completed

• 1 other identifier: 120K044
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Change in Padua Inventory-Washington State University Revision

  Self-report questionnaire of obsessive compulsive symptoms composed of 39 items on a 5-point scale. Total score ranges from 0 to 156. Higher scores indicate greater severity of obsessive-compulsive symptoms (worse outcome).

  Screen, Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up

• Change in Obsessive Beliefs Questionnaire-44

  Self-report questionnaire of maladaptive obsessive-compulsive beliefs composed of 44 items on a 7-point scale. Total score ranges from 44 to 308. Higher score indicates that the individual has more maladaptive obsessive-compulsive beliefs (worse outcome).

  Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up

• Change in 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 (pre-intervention), post-intervention at week 4

• Change in dot-probe task

  Measure of attention biases. Participants are presented 48 trials comprising all combinations of probe type ("←" or "→"), probe position (top or bottom), and picture type (neutral or threat). Each trial begins with the presentation of a central fixation cross for 500 ms. The cross is then replaced by a picture pair presented in the center of the screen for 500ms. After 500 ms, both stimuli disappear and a probe is shown in the location of one of the stimuli. Participants are instructed to indicate as quickly as possible which probe was shown via using keyboardResponse latencies are averaged to provide a single mean reaction time score for each participant. Scores are calculated by subtracting response latencies for trials in which the probe replaces threat stimuli from response latencies for trials in which the probe replaces neutral stimuli. subtracting the average. A negative bias score indicates an attention bias away from threat-related pictures (better outcome).

  Baseline (pre-intervention), post-intervention at week 4

Secondary Outcomes (2)

• Change in Depression Anxiety Stress Scale-21

  Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up

• Change in Positive and Negative Affect Schedule

  Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up

Other Outcomes (1)

• Feedback Form Questionnaire

  post-intervention at week 4

Study Arms (4)

Internet-delivered Combined Cognitive Bias Modification

EXPERIMENTAL

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).

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

Internet-delivered Cognitive Bias Modification-Interpretation

EXPERIMENTAL

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

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

Internet-delivered Cognitive Bias Modification-Attention

EXPERIMENTAL

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

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

Wait-List Control

NO INTERVENTION

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

Interventions

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

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

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

Internet-delivered Cognitive Bias Modification-Attention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Compulsive Behavior

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Impulsive Behavior; Behavior

Study Officials

• Sıla Derin, MA

  Dokuz Eylul University

  STUDY CHAIR

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: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cilinical Psychologist, MA

Model Details: 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

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: October 5, 2020
• Study Start: September 15, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)