A Conditioning Paradigm to Increase Affinity for Sacredness of Life

NCT05541900 | Completed

• 1 other identifier: STUDY00002785
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Suicide, Attempted; Suicide and Self-harm; Non-suicidal Self-injury

Outcome Measures

Primary Outcomes (8)

• Perceived Sacredness of Life

  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

  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

  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

  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.

  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.

  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.

  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.

  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 Outcomes (3)

• Connection to Others

  After treatment completion (week 4)

• Religious and Spiritual Struggles

  After treatment completion (week 4)

• Reasons for Living

  After treatment completion (week 4)

Study Arms (2)

TEC-Sacredness

ACTIVE COMPARATOR

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.

Behavioral: TEC-Sacredness

TEC-Control

PLACEBO COMPARATOR

Control condition of the intervention. The control paradigm maintains the same parameters, however, all three match pairings will be neutral.

Behavioral: TEC-Control

Interventions

TEC-Sacredness BEHAVIORAL

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.

TEC-Sacredness

TEC-Control BEHAVIORAL

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.

TEC-Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Under 18
• Unable to consent

Sponsors & Collaborators

• Florida State University: lead
• Military Suicide Research Consortium: collaborator

Study Sites (1)

Florida State Univeristy

Tallahassee, Florida, 32304, United States

Location

Related Publications (1)

• 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.

  PMID: 27018530 BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Suicide; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Anna Gai, MS

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 15, 2022
• Study Start: May 11, 2022
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)