- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05541900
A Conditioning Paradigm to Increase Affinity for Sacredness of Life
A Conditioning Paradigm to Increase Affinity for Sacredness of Life and Decrease Experiences of Suicide-related Thoughts and Behaviors
Study Overview
Status
Intervention / Treatment
Detailed Description
The present study uses an adapted version of the Therapeutic Evaluative Conditioning paradigm and principles of classical conditioning. Therapeutic Evaluative Conditioning (TEC) was designed as a brief, game-like intervention. The conditioning paradigm will follow the same structure as the original TEC intervention with specific themes modified to the current study aims. The intervention will be administered via a cloud software platform designed specifically for the administration of behavioral paradigms. Following instructions, the participant is shown three pairs of stimuli (i.e., three "matches"). In subsequent trials, one of the three matches is presented, along with non-target matches. The participant is asked to identify and select the correct match on each trial as quickly as possible. On average, each match will be presented on one-third of trials. For the active intervention group, the three match types are as follows: (1) a self-related word paired with a life-related stimulus; (2) a sacredness of life related stimulus paired with a pleasant stimulus; and (3) a neutral stimulus paired with a neutral stimulus. The control paradigm maintains the same parameters, however, all three match pairings will be neutral. Each trial presents only one possible match.
A total of 60 trials are completed in one iteration and it takes approximately 1 - 2 minutes to complete. A total of 5 iterations will be completed each week. Distraction stimuli follow the themes of the target stimuli (i.e., sacredness of life, positive stimuli, self-related words, life-related stimuli, and neutral stimuli) to add difficulty and increase the effects of the conditioning principles. For example, if the pre-determined matched pair for a trial was sacredness of life stimulus with a positive stimulus, the distraction stimuli would be either sacredness of life-related stimuli, positive stimuli, or neutral stimuli.
Pleasant and neutral stimuli will be images obtained from the International Affective Pictures System (IAPS). The sacredness of life stimuli will be generated using images from stock photo websites with free use without attribution licenses (Creative Commons Zero licenses) and words related to sacredness of life. These images and words will include both theistic and nontheistic representation of sacredness of life.
Procedures Involved:
A sample of 200 US adults (100 per group) will be recruited for the present study. All study procedures will be completed online in a location and using a device of the participant's choosing. Participants will be recruited from (1) online web forums focused on topics of self-injury or psychopathology (i.e. Reddit: r/Depression, r/SuicideWatch, r/MentalHealth; Facebook: "Suicide is real I don't want to die [help/talk], Depression/suicide, Suicide, Self Harm, I am not okay **memes&support**, Depression, Anxiety, Self Harm, Suicide Support, Depression, anxiety, and suicide, Suicide Awareness and Prevention, Support Group for Suicide, Depression, and Self Harm, Suicide Awareness, Grieving, Depression, PTSD, PP Depression, Suicide Ideation you must go), (2) email listservs for groups related to self-injury or psychopathology (i.e. listserv of the American Association of Suicidology, listserv of the Society of Clinical Psychology, Division 12 of APA, listserv of the Association of Behavioral and Cognitive Therapies, Zerosuicide listserv), and (3) from general posts on social media platforms (i.e. Facebook, Twitter, and Instagram). Postings will include a link to the screening survey. Should inclusionary criteria be met, the participant will be directed to the consent form and then to start the baseline questionnaire. Following consent, the participant will be required to provide an email address where all study contact will be made (i.e. compensation, weekly reminders, month follow-up reminder, and suicide risk outreach as needed). Participants will be provided with a unique ID number at the time of their first weekly task that they will input at the onset of each iteration of the study in order to link responses across weeks.
The experiment will be conducted fully online and will consist of assessments at baseline, weekly intervals during the treatment period, and at a month following the completion of treatment (baseline, week 1, week 2, week 3, week 4, and posttreatment). Following the completion of the baseline assessments, participants will be randomized to either the active intervention or control.
Emails will be sent on a weekly basis with links to complete each iteration of the intervention and the related questionnaires (for weeks 2 and 4 and posttreatment). Participants will receive daily email reminders for 5 consecutive days or until survey completion for that week, whichever comes first. At the end of each survey completion, participants will be given a series of mental health and suicide resources, regardless of their answers to the questionnaires.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32304
- Florida State Univeristy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English-language Proficiency
- History of suicide-related thoughts and behaviors and/or elevated on depressive disorder symptoms within the past month, as assessed by an elevated scored (5 or higher) and/or endorsement on Item 9 (on suicide risk) of the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
Exclusion Criteria:
- Under 18
- Unable to consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: TEC-Sacredness
Active condition of the intervention.
For the active intervention group, the three match types are as follows: (1) a self-related word paired with a life-related stimulus; (2) a sacredness of life-related stimulus paired with a pleasant stimulus; and (3) a neutral stimulus paired with a neutral stimulus.
|
The participant is asked to identify and select the correct match on each trial as quickly as possible.
Match pairs (i.e., a self-related word paired with a life-related stimulus, a sacredness of life-related stimulus paired with a pleasant stimulus, and a neutral stimulus paired with a neutral stimulus) are first presented to the participant.
A grid is then shown containing one of the match pairs along with distraction stimuli.
|
PLACEBO_COMPARATOR: TEC-Control
Control condition of the intervention.
The control paradigm maintains the same parameters, however, all three match pairings will be neutral.
|
The participant is asked to identify and select the correct match on each trial as quickly as possible.
Match pairs (i.e., a neutral stimulus paired with a neutral stimulus) are first presented to the participant.
A grid is then shown containing one of the match pairs along with distraction stimuli.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Sacredness of Life
Time Frame: After treatment completion (week 4)
|
Scores on the Perceiving Sacredness of Life scale will be utilized as the main outcome for treatment targets.
The Perceiving Sacredness in Life Scale assesses the extent to which an individual perceives life as sacred.
The initial section of the scale lists six statements about God: theistic, deistic, pantheistic or panentheistic, agnostic, atheistic, and none of the above.
This initial section is designed to orient the individual to answer the remaining 28-items (14 theistic and 14 non-theistic) based on their individual definition of God.
Items are rated based on frequency of each experience and scaled from 1 - Never to 5 - Very Often.
Items cover nine categories of perceiving sacredness of life, including, in general, nature and creation, time, everyday life, the journey of life, people in general, relationships with people, the self, and qualities or aspects of life.
Higher scores indicate a higher perception of sacredness of life.
|
After treatment completion (week 4)
|
Perceived Sacredness of Life
Time Frame: One-month following treatment completion
|
Scores on the Perceiving Sacredness of Life scale will be utilized as the main outcome for treatment targets.
The Perceiving Sacredness in Life Scale assesses the extent to which an individual perceives life as sacred.
The initial section of the scale lists six statements about God: theistic, deistic, pantheistic or panentheistic, agnostic, atheistic, and none of the above.
This initial section is designed to orient the individual to answer the remaining 28-items (14 theistic and 14 nontheistic) based on their individual definition of God.
Items are rated based on frequency of each experience and scaled from 1 - Never to 5 - Very Often.
Items cover nine categories of perceiving sacredness of life, including, in general, nature and creation, time, everyday life, the journey of life, people in general, relationships with people, the self, and qualities or aspects of life.
Higher scores indicate a higher perception of sacredness of life.
|
One-month following treatment completion
|
Suicide-Related Thoughts and Behaviors
Time Frame: After treatment completion (week 4)
|
Responses on an online-version of the Self-injurious Thoughts and Behaviors Interview - Short Form will assess circumstances around previous suicidal ideation, attempts, and non-suicidal self-injury (NSSI).
The SITBI-SF is a 72-item measure assessing the circumstances around previous suicidal ideation, attempts, and non-suicidal self-injury (NSSI).
The SITBI-SF includes both yes/no questions on presence of suicide-related experiences as well as individual items assessing severity and other circumstances around suicide-related experiences, with higher ratings indicating more severity.
|
After treatment completion (week 4)
|
Suicide-Related Thoughts and Behaviors
Time Frame: One-month following treatment completion
|
Responses on an online-version of the Self-injurious Thoughts and Behaviors Interview - Short Form will assess circumstances around previous suicidal ideation, attempts, and non-suicidal self-injury (NSSI).
The SITBI-SF is a 72-item measure assessing the circumstances around previous suicidal ideation, attempts, and non-suicidal self-injury (NSSI).
The SITBI-SF includes both yes/no questions on presence of suicide-related experiences as well as individual items assessing severity and other circumstances around suicide-related experiences, with higher ratings indicating more severity.
|
One-month following treatment completion
|
Modified Affect Misattribution Procedure: Implicit affinity to sacredness of life.
Time Frame: After treatment completion (week 4)
|
A modified version of the Affect Misattribution Procedure (AMP) will be used to assess for changes in implicit attitudes on the sacredness of life.
During each trial, one of the stimuli utilized in the active conditioning paradigm is presented on the screen as an emotional prime (75ms), followed by a blank screen (125ms), an ambiguous Chinese symbol (100ms) and a final blank screen.
The participant is instructed to indicate whether they felt the Chinese symbol presented was "pleasant" or "unpleasant".
An AMP score is calculated as the proportion of pleasant ratings within a given stimulus category rated as pleasant.
For the current study, 48 trials of the AMP will be administered.
|
After treatment completion (week 4)
|
Modified Affect Misattribution Procedure: Implicit affinity to sacredness of life.
Time Frame: One-month following treatment completion
|
A modified version of the Affect Misattribution Procedure (AMP) will be used to assess for changes in implicit attitudes on the sacredness of life.
During each trial, one of the stimuli utilized in the active conditioning paradigm is presented on the screen as an emotional prime (75ms), followed by a blank screen (125ms), an ambiguous Chinese symbol (100ms) and a final blank screen.
The participant is instructed to indicate whether they felt the Chinese symbol presented was "pleasant" or "unpleasant".
An AMP score is calculated as the proportion of pleasant ratings within a given stimulus category rated as pleasant.
For the current study, 48 trials of the AMP will be administered.
|
One-month following treatment completion
|
"Death/Life" Implicit Association Test.
Time Frame: After treatment completion (week 4)
|
The d-IAT uses reaction time to measure automatic implicit associations with death and life stimuli.
Procedures follow those of the original IAT, with participants classifying stimuli representing constructs of "death" and "life", and attributes them to "me" and "not me".
A "D" score is calculated for each participant using reaction time.
Positive D scores indicate a stronger association between death and self while negative scores represent a stronger association between life and self.
|
After treatment completion (week 4)
|
"Death/Life" Implicit Association Test.
Time Frame: One-month following treatment completion
|
The d-IAT uses reaction time to measure automatic implicit associations with death and life stimuli.
Procedures follow those of the original IAT, with participants classifying stimuli representing constructs of "death" and "life", and attributes them to "me" and "not me".
A "D" score is calculated for each participant using reaction time.
Positive D scores indicate a stronger association between death and self while negative scores represent a stronger association between life and self.
|
One-month following treatment completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Connection to Others
Time Frame: After treatment completion (week 4)
|
The Interpersonal Needs Questionnaire (INQ-15) is a measure assessing beliefs about being a burden on others (i.e.
perceived burdensomeness), and the extent to which an individual feels disconnected from others (i.e.
thwarted belongingness).
The scale is made up of a total of 15 items, six items assess for belongingness, and nine items measure burdensomeness.
Responses are rated on a 7-point Likert-scale (1 = not at all true for me; 7 = very true for me), with higher scores reflecting higher levels of thwarted belongingness and perceived burdensomeness.
|
After treatment completion (week 4)
|
Religious and Spiritual Struggles
Time Frame: After treatment completion (week 4)
|
The Religious and Spiritual Struggles Scale was developed as a self-report measure to assess supernatural, interpersonal, and intrapersonal struggles known as religious and spiritual struggles.
The measure was developed to be relevant to an individual irrespective of their perceived level of religiosity and spirituality.
The 26-item scale includes six subscales: Divine, Demonic, Interpersonal, Moral, Ultimate Meaning, and Doubt.
Items are rated on a 5-point scale (1 = not at all/does not apply; 5 = a great deal).
Higher scores indicate more religious and spiritual struggles.
|
After treatment completion (week 4)
|
Reasons for Living
Time Frame: After treatment completion (week 4)
|
The Reasons For Living Scale is a 48-item self-report scale that assesses reasons for not dying by suicide.
The scale includes six sub-scales, including survival and coping beliefs, responsibility to family, child-related concerns, fear of suicide, fear of social disapproval, and moral objections.
Each item is rated on its importance on a 6-point scale (1 = not at all important; 6 = extremely important).
Scale scores are the mean rating of each item set.
|
After treatment completion (week 4)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna Gai, MS, Florida State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00002785
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicidal Ideation
-
University of WashingtonUnited States Department of Defense; Military Suicide Research ConsortiumCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation ActiveUnited States
-
The Catholic University of AmericaUniversity of Washington; VA Office of Research and DevelopmentCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
Emory UniversityGeorgia Institute of TechnologyCompletedSuicide, Suicidal IdeationUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; University of Michigan; Duke University; US Department... and other collaboratorsUnknownSuicide, Attempted | Suicidal Ideation ActiveUnited States
-
Technische Universität DresdenUnknownDepression | Suicidal Ideation/BehaviorGermany
-
International Islamic University, IslamabadRecruitingImpulsivity | Suicidal Ideation and BehaviorPakistan
-
VA Office of Research and DevelopmentCentral Texas Veterans Health Care SystemRecruitingHealth | Reintegration Difficulties | Suicidal Ideation and Behaviors | ConnectednessUnited States
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Eisenhower Army Medical CenterAugusta University; The Geneva Foundation; Congressionally Directed Medical Research...CompletedSuicidal Ideation | Suicide | Suicidal Intention | Suicidal Impulses | Suicidal and Self-Injurious Behavior | Suicidal DepressionUnited States
-
Ohio State UniversityUniversity of Minnesota; Rutgers UniversityCompletedSuicidal Ideation | SuicidalUnited States
Clinical Trials on TEC-Sacredness
-
Nachum Soroker, MDTel Aviv UniversityUnknown
-
Quanta MedicalLattice MedicalRecruitingBreast Reconstruction | Breast Cancer Female | Breast Cancer PreventGeorgia, France
-
VA Office of Research and DevelopmentCompletedDiabetesUnited States
-
Rambam Health Care CampusRecruitingDental Implants,Peri-implantitis,SmokingIsrael
-
REGINA ALLANDE CUSSOCompletedOlder People | Social Exclusion | Care DependencySpain
-
Shanghai Zhongshan HospitalActive, not recruiting
-
Brooke Army Medical CenterUnknown
-
Beijing Jishuitan HospitalCompletedBone Marrow Stimulating | Modified Suture BridgeChina
-
University Hospital, Basel, SwitzerlandDr Josef Vavrina, HNO Seepraxen, CH-8810 Horgen, ZurichCompletedNasal Cartilage Septum PerforationsSwitzerland
-
University Hospital, Basel, SwitzerlandSwiss National Science Foundation; Wuerzburg University Hospital; Clinical Trial...Not yet recruitingPatellofemoral OsteoarthritisSwitzerland, Germany