- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06130020
Comparing Targets of Expressive Writing
November 13, 2023 updated by: Erik Nook, Trustees of Princeton University
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
159
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Claire Whiting, MRes
- Phone Number: (609) 258-5064
- Email: lemolab@princeton.edu
Study Locations
-
-
New Jersey
-
Princeton, New Jersey, United States, 08540
- Recruiting
- Peretsman Scully Hall
-
Contact:
- Claire Whiting, MRes
- Email: claire.whiting@princeton.edu
-
Sub-Investigator:
- Claire Whiting, MRes
-
Principal Investigator:
- Erik Nook, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self
The Self group is instructed to carry out the expressive writing exercise as if they were writing to themselves.
|
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.
|
Experimental: Other
The Other group is instructed to carry out the expressive writing exercise as if they were writing to someone they feel close to.
|
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.
|
Placebo Comparator: Control
The Control group is asked to write down a factual description of their routine that day, as if they were writing to themselves.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Initial visit (day 1), mid-point (day 7) final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Depression
Time Frame: Initial visit (day 1), mid-point (day 7), final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Quality
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Depression, Anxiety, and Stress
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Alexithymia (TAS)
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Alexithymia (PAQ)
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Emotion Regulation
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Interpersonal Regulation
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Social Desirability
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Social Connectedness
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
|
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)
|
Daily Sleep
Time Frame: Daily from day 1 to day 14
|
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
|
Sleepiness
Time Frame: Daily from day 1 to day 14
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erik Nook, PhD, Princeton University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2023
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
November 1, 2024
Study Registration Dates
First Submitted
November 6, 2023
First Submitted That Met QC Criteria
November 6, 2023
First Posted (Actual)
November 13, 2023
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Princeton15734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Upon study completion, a subset of the de-identified data will be transferred to OSF, which will provide public access to this data.
Writing content will not be transferred to OSF, though we will make thoroughly de-identified data available to researchers who have completed appropriate ethics training, agree to confidentiality restrictions, and whose research goals are in line with the purpose of this study.
IPD Sharing Time Frame
Beginning after publication of results with no end date.
IPD Sharing Access Criteria
A subset of the de-identified data will be publicly available on the OSF.
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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