Obsessive-Compulsive DisorderNCT03799419
Cognitive Bias Modification for OCD
A study testing Cognitive bias modification for interpretation bias, Psychoeducation and Approach avoidance training in people with Obsessive-Compulsive Disorder and Obsessive-compulsive Disorders and Symptoms, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder, Obsessive-compulsive Disorders and Symptoms
- What is being tested?
- Cognitive bias modification for interpretation bias, Psychoeducation and Approach avoidance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 23 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD
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.
- Being tested
- Cognitive bias modification for interpretation bias, Psychoeducation, Approach avoidance training, Inactive sham approach avoidance training
- Keywords
- cognitive bias modification, interpretation bias, approach avoidance
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive bias modification for interpretation biasBehavioural
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.
PsychoeducationBehavioural
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 trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive bias modification with treatment as usual | Experimental | Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting interpretation bias Receives: Behavioral: Cognitive bias modification for interpretation bias |
| Psychoeducation with treatment as usual | Sham comparator | Participants in this group will receive usual treatment in the program and 8 sessions of psychoeducation Receives: Behavioral: Psychoeducation |
| Approach avoidance training with treatment as usual | Experimental | Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting automatic approach tendencies Receives: Behavioral: Approach avoidance training |
| Inactive sham approach avoidance training | Sham comparator | Participants in this group will receive usual treatment in the program and 8 sessions of a sham approach avoidance training Receives: Behavioral: Inactive sham approach avoidance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0, 2, 4, and 8
Secondary outcomes (9)
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.
Measured: Weeks 0, 4, and 8
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.
Measured: Weeks 0, 4, and 8
Change in Suicide Implicit Association Test
Computerized task which assesses implicit thoughts about self-injury, death, and suicide.
Measured: Weeks 0, 2, and 4
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
Measured: Weeks 0, 1, 2, 3, and 4
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.
Measured: Week 0
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.
Measured: Week 4
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.
Measured: Weeks 0, 2, and 4
Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales
24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed.
Measured: Weeks 0, 2, 4, and 8
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.
Measured: Weeks 0, 2, 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Apr 2019
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha J Falkenstein, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799419
- Sponsor's protocol ID
- 2017P002864
- Status last verified
- Jul 2024
- First submitted
- 2 Jan 2019
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD
- ClinicalTrials.gov ID
- NCT03799419
- Acronym / sponsor ID
- 2017P002864
- Keywords
- cognitive bias modification, interpretation bias, approach avoidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive bias modification with treatment as usual | Experimental | Behavioral: Cognitive bias modification for interpretation biasParticipants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting interpretation bias |
| Psychoeducation with treatment as usual | Sham comparator | Behavioral: PsychoeducationParticipants in this group will receive usual treatment in the program and 8 sessions of psychoeducation |
| Approach avoidance training with treatment as usual | Experimental | Behavioral: Approach avoidance trainingParticipants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting automatic approach tendencies |
| Inactive sham approach avoidance training | Sham comparator | Behavioral: Inactive sham approach avoidance trainingParticipants in this group will receive usual treatment in the program and 8 sessions of a sham approach avoidance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive bias modification for interpretation biasEight 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. | Behavioural | Cognitive bias modification with treatment as usual |
| PsychoeducationEight 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. | Behavioural | Psychoeducation with treatment as usual |
| Approach avoidance trainingEight 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). | Behavioural | Approach avoidance training with treatment as usual |
| Inactive sham approach avoidance trainingEight 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. | Behavioural | Inactive sham approach avoidance training |
Primary outcome
Change in Average Score on Obsessive Beliefs Questionnaire
Time frame: Weeks 0, 2, 4, and 8
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.
9 secondary outcomes
Change in Average Score on Yale-Brown Obsessive Compulsive Scale
Time frame: Weeks 0, 4, and 8
Change in Columbia-Suicide Severity Rating Scale
Time frame: Weeks 0, 4, and 8
Change in Suicide Implicit Association Test
Time frame: Weeks 0, 2, and 4
Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity.
Time frame: Weeks 0, 1, 2, 3, and 4
Credibility/Expectancy Questionnaire
Time frame: Week 0
Exit Interview
Time frame: Week 4
Change in Behavioral Approach Test
Time frame: Weeks 0, 2, and 4
Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales
Time frame: Weeks 0, 2, 4, and 8
Dimensional Obsessive-Compulsive Scale
Time frame: Weeks 0, 2, 4, and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive bias modification for interpretation bias, Psychoeducation and Approach avoidance training in people with Obsessive-Compulsive Disorder and Obsessive-compulsive Disorders and Symptoms, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Score on Obsessive Beliefs Questionnaire (time frame: Weeks 0, 2, 4, and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.