NCT04575805|Completed
Internet-delivered CBM-C for OC-symptoms
Internet-delivered Combined Cognitive Bias Modification (iCBM-C) in People With High Obsessive Compulsive Symptoms: A Factorial Randomised Controlled Trial
Loading search results
Internet-delivered Combined Cognitive Bias Modification (iCBM-C) in People With High Obsessive Compulsive Symptoms: A Factorial Randomised Controlled Trial
Sponsor study identifier
interventional
94
1 country
1
Study Start
September 15, 2020
Actual (reported)Primary Completion
March 1, 2021
Actual (reported)Study Completion
March 1, 2021
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2020
Actual (reported)September 26, 2020
Actual (reported)October 5, 2020
Actual (reported)March 1, 2021
Actual (reported)March 1, 2021
Actual (reported)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).
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
Feedback Form Questionnaire
post-intervention at week 4
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).
CBM Version 2 is an internet-delivered Cognitive Bias Modification-Interpretation intervention taking place over 4 weeks (eight sessions, twice per week).
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.
Dokuz Eylul University
Izmir, Turkey (Türkiye)
Sıla Derin, MA
Dokuz Eylul University
94 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2020
Digital OC Training in Children and Adolescents
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
CBM Version 3 is an internet-delivered Cognitive Bias Modification-Attention intervention taking place over 4 weeks (eight sessions, twice per week).
This arm is wait-list control group which will also receive internet-delivered Combined Cognitive Bias Modification intervention after the follow-up assessment
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Posted
October 5, 2020
Study Start
September 15, 2020
Actual (reported)Primary Completion
March 1, 2021
Actual (reported)Study Completion
March 1, 2021
Actual (reported)Last Updated
August 14, 2023
Record last verified: 2023-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: