Construal Level as a Novel Pathway for Affect Regulation and Cancer Control

NCT04620915 | Active Not Recruiting

• 1 other identifier: EPCS27942
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the proposed research is to conduct a longitudinal experiment on the neurocognitive pathways and individual differences in high-level construal for affect regulation and smoking cessation. The population is adult smokers aged 25-55 who have tried and failed to quit and who are experiencing poverty. The primary endpoints are (a) the similarity in neural representation of high-level construal to one of two candidate pathways, (b) the presence of meaningful individual differences in the neural representation of high-level construal, and (c) as a secondary endpoint, the effect size of the high-level construal condition on smoking as measured by cigarettes per day. Each of these endpoints corresponds to a specific null hypothesis. The null hypothesis for the first endpoint is that high-level construal is not significantly different in its neural representation from down-regulation of craving, which would suggest that high-level construal does not operate through distinct mechanisms from traditional treatments. The null hypothesis for the second endpoint is that the between-subjects variability in the neural representation of construal level does not significantly relate to relevant individual differences measures (e.g., traits, task behavior), which would suggest that individual differences are not meaningfully related to outcomes. Finally, the null hypothesis for the secondary endpoint is that the magnitude of the effect of high-level construal on smoking as measured by reductions in average cigarettes per day is not significantly greater than in the other conditions, which would suggest that the efficacy of the high-level construal condition is not significantly greater than a standard text-messaging intervention. The primary endpoints will be assessed at baseline and change from pre-to-post training (8 weeks).

Conditions

Smoking Cessation; Smoking Reduction; Cancer

Keywords

Smoking; Construal level; Cigarettes; Quitting

Outcome Measures

Primary Outcomes (6)

• Aim 1: Neural similarity at baseline among the proposed psychological mechanisms

  Neural similarity as indexed by Pearson's correlations derived from the similarity matrices produced by Representational Similarity Analysis. The correlation is among the vectorized 3D images representing the patterns of BASELINE functional neural activity related to (a) high-level construal, (b) down-regulation, and (c) up-regulation of goal energization. There will be 3 correlations in total (a with b, a with c, and b with c).

  At baseline

• Aim 1: Neural similarity in pre-post change among the proposed psychological mechanisms

  Neural similarity as indexed by Pearson's correlations derived from the similarity matrices produced by Representational Similarity Analysis. The correlation is among the vectorized 3D images representing the patterns of PRE-TO-POST CHANGE in the functional neural activity related to (a) high-level construal, (b) down-regulation, and (c) up-regulation of goal energization. There will be 3 correlations in total (a with b, a with c, and b with c).

  56 days after the baseline session

• Aim 2: Correlation of pattern representation of high-level construal with survey measure

  Correlation between the similarity matrices produced by Representational Similarity Analysis and the self-report measures assessed at baseline. The measure is the Pearson's correlation between (a) the vectorized 3D image representing the patterns of baseline functional neural activity related to high-level construal and (b) the Levels of Personal Agency Questionnaire. The Outcome is the Pearson's r between (a) and (b).

  Within two weeks of enrollment

• Aim 2: Degree of prediction success of change in smoking from surveys

  Cross-validated machine learning (ML) prediction of endpoint (56-day) smoking quantity in terms of cigarettes per day based on responses to baseline responses to the Levels of Personal Agency Questionnaire. Degree of prediction will be expressed in Pearson's r correlation between (a) actual # of cigarettes per day at endpoint and (b) ML-predicted # of cigarettes per day.

  56 days after the baseline session

• Aim 2: Prediction success of change in smoking from task data

  Cross-validated machine learning prediction of endpoint (56-day) smoking quantity in terms of cigarettes per day based on responses to behavioral performance on the Construal Level Task as measured by the difference in response time in milliseconds between in the high- and low-level conditions. Degree of prediction will be expressed in Pearson's r correlation units.

  56 days after the baseline session

• Aim 2: Prediction of craving ratings from multivariate representations of high-level construal

  Cross-validated machine learning prediction of baseline craving ratings during reactivity to personalized cigarette smoking cues based on multivariate neural representation of high-level construal. Ratings are on a 1 to 5 scale from "no craving" to "extreme craving". Degree of prediction will be expressed in Pearson's r units. Higher r values indicate better prediction of craving ratings.

  Within two weeks of enrollment

Secondary Outcomes (2)

• Aim 3: Effect size of high-level construal on smoking at endpoint

  56 days after the baseline session

• Aim 3: Time-series of the effect size of high-level construal on smoking across the training period

  Inclusive of days 1-56 of the training period

Study Arms (3)

High-level construal

EXPERIMENTAL

Participants will be sent messages asking them to imagine what their lives will look like in the future if they succeed ("What would quitting mean to you and your family's future?"; Yeager et al., 2014).

Behavioral: High-level construal

Effortful down-regulation of craving for cigarettes

EXPERIMENTAL

Participants will be sent messages that encourage inhibitory control of cravings for cigarettes (e.g., using cognitive reappraisal or attentional control) and that provide strategies to do so (e.g., "When you feel an urge to smoke, think about the health consequences").

Behavioral: Down-regulation of craving for cigarettes

Up-regulation of goal energization

EXPERIMENTAL

Participants will be sent messages that encourage them to consider the core values that drive their desire to quit smoking.

Behavioral: Up-regulation of goal energization

Interventions

High-level construal BEHAVIORAL

In the high-level construal condition, participants will be sent messages asking them to consider why they are quitting ("What are your main reasons for quitting?") and to imagine what their lives will look like in the future if they succeed ("What would quitting mean to you and your family's future?"; Yeager et al., 2014). The corpus for this condition is 100 messages composed by a large independent sample of mTurk workers who are smokers and validated by a team of RAs trained to 0.8 reliability on ratings of high-level construal. To meet criteria for inclusion, a message must be rated as significantly closer to high-level (vs. low-level) on a rating scale of construal level. In addition to the texting, participants will complete biweekly online "booster" sessions using Qualtrics with a custom, personalized link sent to the participant via email and text.

High-level construal

Down-regulation of craving for cigarettes BEHAVIORAL

In the down-regulation of craving condition, participants will be sent messages that encourage inhibitory control of cravings for cigarettes (e.g., using cognitive reappraisal or attentional control) and that provide strategies to do so (e.g., "When you feel an urge to smoke, think about the health consequences"). The corpus for this condition is 100 messages composed by a large, independent sample of mTurk smokers and validated by a team of RAs trained to 0.8 reliability on ratings of plausibility AND effortful cognitive inhibition or control. In addition to the texting, participants will complete biweekly online "booster" sessions using Qualtrics with a custom, personalized link sent to the participant via email and text.

Effortful down-regulation of craving for cigarettes

Up-regulation of goal energization BEHAVIORAL

In the up-regulation of goal energization condition, participants will be sent messages that encourage them to consider the core values that drive their desire to quit smoking. These messages will name a specific core value that the participant rated in the top three (of 19) during the baseline session, and will draw a connection between quitting and the core value. For example, a message for a person who nominated "family" as one of her top three core values might read, "Quitting will help you model a healthy lifestyle for your family." This intervention is grounded in robust theory and evidence supporting Self-Affirmation Theory. The corpus for this condition is 100 messages composed by a large, independent sample of mTurk smokers and validated by a team of RAs trained to 0.8 reliability in correctly identifying to which core value the message is tied. In addition to the texting, participants will complete biweekly online "booster" sessions using Qualtrics.

Up-regulation of goal energization

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Low-SES
• Persistent smokers: cigarette smokers (at least 10 cigarettes/day for at least 1 year)
• Want to quit but have tried and failed at least once
• Income-to-needs ratio (INR) is less than 2.0, meaning that their household income adjusted for household size is below 200% of the federal poverty line
• Ages 25-55

You may not qualify if:

• Metal implants (e.g., braces, permanent retainers, pins)
• Metal fragments, pacemakers or other electronic medical implants
• Claustrophobia
• Weight ˃ 550 lbs.
• Women who are pregnant or believe they might be pregnant

Sponsors & Collaborators

• University of Oregon: lead
• Ohio State University: collaborator

Study Sites (2)

University of Oregon, Lewis Integrative Sciences Building

Eugene, Oregon, 97403, United States

Location

University of Oregon, Social and Affective Neuroscience Laboratory

Eugene, Oregon, 97403, United States

Location

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MeSH Terms

Conditions

Smoking Cessation; Smoking Reduction; Neoplasms; Smoking

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Elliot T Berkman, Ph.D.

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology, Associate Director of the Center for Translational Neuroscience

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: November 9, 2020
• Study Start: October 11, 2021
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (2)