Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06130020
Other study ID # Princeton15734
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2023
Est. completion date November 2024

Study information

Verified date November 2023
Source Trustees of Princeton University
Contact Claire Whiting, MRes
Phone (609) 258-5064
Email lemolab@princeton.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Expressive writing involves writing about one's deepest thoughts and feelings surrounding an emotional event. The current literature on the efficacy of expressive writing is mixed and warrants further investigation into how, when, and for whom expressive writing is an effective intervention. The goal of this study is to compare the efficacy of expressive writing interventions in young adults when people imagine that they're writing to themselves vs. a loved one. Participants will carry out an expressive writing exercise for 14 consecutive days. Participants are randomized into 3 groups: Self, Other, and Control. The Self group is instructed to write as if they were talking to themselves. The Other group is instructed to direct their writing to someone they feel close to. The Control group is asked to write down a factual description of their routine that day, and direct this writing to themselves. We will recruit participants until we have usable data from 53 participants per group (i.e., 159 in total).


Recruitment information / eligibility

Status Recruiting
Enrollment 159
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - US-based - Fluent English - Combined GAD-7 and PHQ-8 score of = 5 Exclusion Criteria: - "Completion" of a writing session requires participants to spend at least 15 minutes on the writing page. We will monitor completion of the daily writing exercise, and will contact participants who miss or spend less than 15 minutes on the exercise. Participants who fail to complete 3 consecutive daily writing sessions will be deemed non-compliant, removed from the study, and paid a prorated amount for the tasks they have completed in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Expressive Writing: Self
This intervention consists of a daily expressive writing exercise carried out for 14 consecutive days, for 15 minutes each day. Expressive writing involves asking participants to write about their deepest thoughts and feelings surrounding an emotional event. Participants in this condition will write as if they are writing to themselves.
Expressive Writing: Other
This intervention consists of a daily expressive writing exercise carried out for 14 consecutive days, for 15 minutes each day. Expressive writing involves asking participants to write about their deepest thoughts and feelings surrounding an emotional event. Participants in this condition will write as if they are writing/talking to someone they're close to.
Factual Writing
This intervention consists of a daily factual writing exercise carried out for 14 consecutive days, for 15 minutes each day. Participants are asked to give a factual description of their day. This is a standard control for Expressive writing studies. Participants in this condition will be asked to direct their writing to themselves.

Locations

Country Name City State
United States Peretsman Scully Hall Princeton New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Trustees of Princeton University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pennebaker JW, Beall SK. Confronting a traumatic event: toward an understanding of inhibition and disease. J Abnorm Psychol. 1986 Aug;95(3):274-81. doi: 10.1037//0021-843x.95.3.274. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Sleep Quality Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0-21, with higher scores indicating poorer sleep quality. Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
Other Depression, Anxiety, and Stress Depression, Anxiety, and Stress-21 (DASS-21). Scores for each of the three subscales range from 0-42, with higher scores indicating greater severity. Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
Other Alexithymia (TAS) Toronto Alexithymia Scale-20 (TAS-20). Scores range from 20-100, with higher scores indicating greater alexithymia. Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
Other Alexithymia (PAQ) Perth Alexithymia Questionnaire (PAQ). Total scores range from 24-168, with higher scores indicating greater alexithymia. Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
Other Emotion Regulation Emotion Regulation Questionnaire (ERQ). Scores for the reappraisal and suppression subscales range from 6-42 and 4-28 respectively. Higher scores indicate greater use of the strategy. Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
Other Interpersonal Regulation Interpersonal Regulation Questionnaire (IRQ). Total scores range from 16-112, with higher scores indicating greater tendency to use/efficacy of interpersonal emotion regulation. Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
Other Social Desirability Marlow-Crowne Social Desirability Scale (MC-SDS). Scores range from 0-33, with higher scores indicating greater social desirability. Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
Other Social Connectedness Social Connectedness Scale (SCS). Scores range from 8-48, with higher scores indicating greater connectedness to others. Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
Other Daily Sleep Consensus Sleep Diary (CSD). Items are used to derive estimates of sleep indices, such as time in bed and total sleep time. Daily from day 1 to day 14
Other Sleepiness Karolinska Sleepiness Scale (KSS). Scores on this single-item scale range from 1-10, with higher scores indicating greater sleepiness. Daily from day 1 to day 14
Primary Anxiety Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0-21, with higher scores indicating more severe anxiety. Initial visit (day 1), mid-point (day 7) final visit (day 15), 1-month follow-up (1 month after day 14)
Primary Depression Patient Health Questionnaire-8 (PHQ-8). Scores range from 0-24, with higher scores indicating more severe depression. Initial visit (day 1), mid-point (day 7), final visit (day 15), 1-month follow-up (1 month after day 14)
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1