Clinical trial NCT05541900: A Conditioning Paradigm to Increase Affinity for Sacredness of Life
Official title: A Conditioning Paradigm to Increase Affinity for Sacredness of Life and Decrease Experiences of Suicide-related Thoughts and Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Suicide, Attempted
Suicide and Self-harm
Non-suicidal Self-injury
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Military Suicide Research Consortium
First posted: 2022-09-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Suicide-related experiences affect millions of people every year in the United States. Through decades of research, interventions targeting these experiences have developed with varied empirical support. Many of these treatments require regular attendance to in-person sessions with a trained behavioral health professional. Limitations of in-person services have led to the development of digital-based interventions, such as Therapeutic Evaluative Conditioning (TEC). TEC is based in evaluative conditioning principles and is a brief (1-2 minutes) digital intervention designed to increase aversion to self-injurious behaviors while decreasing aversion to the self through a match game-like task. Initial assessment of the intervention demonstrated promising results although treatment effects did not remain over time. Separately, sanctification, or the process through which aspects of life are perceived as having divine character and significance, can come from a theistic or nontheistic background and does not require a belief in a God or higher power to be experienced. When something is discovered as sacred, that sacredness becomes a priority for the individual, initiating motivation to conserve what is viewed as sacred. The primary aim of the current study is to develop and test the effectiveness of an adapted version of TEC designed to increase affinity for sacredness of life and increase the connection to life as mechanisms for decreasing suicide-related experiences. Results will provide insight into the perception of sacredness of life as a potential treatment target and are foundational work in a novel approach to address the public health priority of prevention and treatment of suicide-related experiences.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Sacredness of Life
timeFrame: After treatment completion (week 4)
measure: Perceived Sacredness of Life
timeFrame: One-month following treatment completion
measure: Suicide-Related Thoughts and Behaviors
timeFrame: After treatment completion (week 4)
measure: Suicide-Related Thoughts and Behaviors
timeFrame: One-month following treatment completion
measure: Modified Affect Misattribution Procedure: Implicit affinity to sacredness of life.
timeFrame: After treatment completion (week 4)
measure: Modified Affect Misattribution Procedure: Implicit affinity to sacredness of life.
timeFrame: One-month following treatment completion
measure: "Death/Life" Implicit Association Test.
timeFrame: After treatment completion (week 4)
measure: "Death/Life" Implicit Association Test.
timeFrame: One-month following treatment completion
Secondary outcomes:
measure: Connection to Others
timeFrame: After treatment completion (week 4)
measure: Religious and Spiritual Struggles
timeFrame: After treatment completion (week 4)
measure: Reasons for Living
timeFrame: After treatment completion (week 4)
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State Univeristy
state: Florida
Study officials:
affiliation: Florida State University
name: Anna Gai, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franklin JC, Fox KR, Franklin CR, Kleiman EM, Ribeiro JD, Jaroszewski AC, Hooley JM, Nock MK. A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials. J Consult Clin Psychol. 2016 Jun;84(6):544-57. doi: 10.1037/ccp0000093. Epub 2016 Mar 28.