Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03799419
Other study ID # 2017P002864
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date December 2024

Study information

Verified date March 2023
Source Mclean Hospital
Contact Martha Falkenstein
Phone 617-855-4424
Email mfalkenstein@mclean.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will conduct the development and preliminary evaluation of Cognitive Bias Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as augmentations to treatment as usual for OCD and related disorders. CBM-I refers to computerized interventions designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are re-trained. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I and AAT. Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from a treatment program for these disorders and participants will be randomly assigned to either receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Currently receiving treatment at the McLean Hospital OCD Institute - For CBM-I condition only: report a score of at least 131 on the Obsessive Beliefs Questionnaire-44 upon admission to the OCD Institute - For AAT condition only: endorse score of at least 7 on the DOCS subscale #1 (contamination subscale) upon admission to the OCD Institute - Able to complete a computer task for 20 minutes - Consent to main OCD Institute study protocol Exclusion Criteria: - Currently undergoing electroconvulsive therapy (ECT) - Current symptoms of acute mania or psychosis - A reported diagnosis at admission of a psychotic disorder - History of traumatic brain injury

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive bias modification for interpretation bias
Eight sessions of scenario-based CBM-I training for OCD will be administered, based on the widely-used paradigm of ambiguous scenario training developed by Mathews and Mackintosh (2000), in which participants are presented with scenarios that are ambiguous in whether or not they are threatening. Participants will complete a computer task consisting of a series of written scenarios designed to improve interpretation and attributional biases; these scenarios conclude with word fragments, which participants must fill in to resolve the ambiguity.
Psychoeducation
Eight sessions of psychoeducation will be administered, which will describe symptoms of anxiety, the nature of biased thinking in anxiety, and summarize common psychosocial as well as pharmacological treatments for anxiety. The sessions will provide relevant information but will not provide training in changing thinking styles.
Approach avoidance training
Eight sessions of this computerized training program will be used to train approach tendencies, following previously validated procedures (Najmi, Kuckertz, & Amir, 2010). During the training program, participants will view a series of these images and be prompted to push or pull a joystick according to prompts on the screen, instead of the content of the picture. Avoidance will be stimulated through both pushing away (images on the screen will decrease in size upon the joystick being pushed), and approach will be stimulated through pulling towards pictures (images will increase in size to simulate approach).
Inactive sham approach avoidance training
Eight sessions of the approach avoidance training will be administered, however the percentage of push vs pull trials will be altered in this sham version of the training.

Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Average Score on Obsessive Beliefs Questionnaire Measure of interpretation biases, specifically: Inflated Responsibility/Overestimation of Threat, Perfectionism/Intolerance of Uncertainty, and Importance/Control of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity. Weeks 0, 2, 4, and 8
Secondary Change in Average Score on Yale-Brown Obsessive Compulsive Scale Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity. Weeks 0, 4, and 8
Secondary Change in Columbia-Suicide Severity Rating Scale An interviewer-rated assessment of retrospective suicidality as well as recent suicidal ideation and behavior. Minimum total score 0, maximum total score 5, higher total scores indicate more suicidal ideation and/or behavior. Weeks 0, 4, and 8
Secondary Change in Suicide Implicit Association Test Computerized task which assesses implicit thoughts about self-injury, death, and suicide. Weeks 0, 2, and 4
Secondary Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity. Self-report measure of suicidality Weeks 0, 1, 2, 3, and 4
Secondary Credibility/Expectancy Questionnaire Measure of treatment expectancy and rationale credibility in our study. The items are rated on 9-point scales, with a total score range of 3 to 27. Greater scores indicate greater expectations and perceptions of treatment credibility. Week 0
Secondary Exit Interview This interview will be conducted by a member of the study staff to obtain participant feedback on satisfaction and how the intervention might be improved. Week 4
Secondary Change in Behavioral Approach Test Behavioral Approach Test (BAT) will be administered as a measure of OCD-related avoidance, based on previously validated procedures (Cougle et al., 2007; Amir, Kuckertz, & Najmi, 2013). Participants rate peak anxiety 0-100 for each step of approaching feared stimuli.
Three different types of BAT will be implemented in order to measure avoidance with multiple types of contaminants, each with six steps on a hierarchy to be completed sequentially, providing a rating of anxiety 0-100 for each step.
Weeks 0, 2, and 4
Secondary Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales 24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed. Weeks 0, 2, 4, and 8
Secondary Dimensional Obsessive-Compulsive Scale (DOCS; Abramowitz et al., 2010) participants with contamination fears will be identified by their DOCS contamination subscale score; the DOCS is part of the admission measures in the OCD Institute's main study protocol. Additionally, we will examine these scores as an outcome measure for contamination-related obsessions and compulsions. It includes 20 items and is rated 0-4. Weeks 0, 2, 4, and 8
See also
  Status Clinical Trial Phase
Recruiting NCT04934007 - Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder N/A
Recruiting NCT04071990 - Family Involvement in CBGT of OCD: a Randomized Controlled Trial N/A
Completed NCT02541968 - Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Recruiting NCT05391503 - Light Therapy for Obsessive-compulsive Disorder (OCD) N/A
Recruiting NCT04539951 - Pragmatic Trial of Obsessive-compulsive Disorder Phase 2
Completed NCT03416504 - Methods for Managing Intrusive Thoughts N/A
Not yet recruiting NCT06029738 - Effect on Obsessive-Compulsive Beliefs and Symptoms of MCT-OCD N/A
Recruiting NCT02844049 - European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS N/A
Terminated NCT02909660 - What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder N/A
Completed NCT02911324 - Cannabinoid Medication for Adults With OCD Phase 1/Phase 2
Completed NCT02217995 - Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients N/A
Terminated NCT02234011 - A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder Phase 2
Withdrawn NCT01953042 - Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders N/A
Completed NCT02655926 - Deep Brain Stimulation for Severe Obsessive Compulsive Disorder N/A
Completed NCT04919785 - Deep Brain Stimulation in Severe Obsessive-compulsive Disorder N/A
Terminated NCT00758966 - Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder Phase 2
Completed NCT00742664 - Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project Phase 1/Phase 2
Completed NCT00523718 - Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder Phase 2
Completed NCT00074815 - Treatment of Obsessive Compulsive Disorder in Children Phase 3