Comparing Targets of Expressive Writing
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Claire Whiting, MRes
- Phone Number: (609) 258-5064
- Email: lemolab@princeton.edu
Study Locations
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New Jersey
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Princeton, New Jersey, United States, 08540
- Peretsman Scully Hall
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Self
The Self group is instructed to carry out the expressive writing exercise as if they were writing to themselves.
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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.
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety
Time Frame: Initial visit (day 1), mid-point (day 7) final visit (day 15), 1-month follow-up (1 month after day 14)
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Generalized Anxiety Disorder-7 (GAD-7).
Scores range from 0-21, with higher scores indicating more severe anxiety.
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Initial visit (day 1), mid-point (day 7) final visit (day 15), 1-month follow-up (1 month after day 14)
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Depression
Time Frame: Initial visit (day 1), mid-point (day 7), final visit (day 15), 1-month follow-up (1 month after day 14)
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Patient Health Questionnaire-8 (PHQ-8).
Scores range from 0-24, with higher scores indicating more severe depression.
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Initial visit (day 1), mid-point (day 7), final visit (day 15), 1-month follow-up (1 month after day 14)
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Other Outcome Measures
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)
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Pittsburgh Sleep Quality Index (PSQI).
Total scores range from 0-21, with higher scores indicating poorer sleep quality.
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Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Depression, Anxiety, and Stress
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Depression, Anxiety, and Stress-21 (DASS-21).
Scores for each of the three subscales range from 0-42, with higher scores indicating greater severity.
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Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Alexithymia (TAS)
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Toronto Alexithymia Scale-20 (TAS-20).
Scores range from 20-100, with higher scores indicating greater alexithymia.
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Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Alexithymia (PAQ)
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Perth Alexithymia Questionnaire (PAQ).
Total scores range from 24-168, with higher scores indicating greater alexithymia.
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Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Emotion Regulation
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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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.
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Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Interpersonal Regulation
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Interpersonal Regulation Questionnaire (IRQ).
Total scores range from 16-112, with higher scores indicating greater tendency to use/efficacy of interpersonal emotion regulation.
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Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Social Desirability
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Marlow-Crowne Social Desirability Scale (MC-SDS).
Scores range from 0-33, with higher scores indicating greater social desirability.
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Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Social Connectedness
Time Frame: Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Social Connectedness Scale (SCS).
Scores range from 8-48, with higher scores indicating greater connectedness to others.
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Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)
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Daily Sleep
Time Frame: Daily from day 1 to day 14
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Consensus Sleep Diary (CSD).
Items are used to derive estimates of sleep indices, such as time in bed and total sleep time.
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Daily from day 1 to day 14
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Sleepiness
Time Frame: Daily from day 1 to day 14
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Karolinska Sleepiness Scale (KSS).
Scores on this single-item scale range from 1-10, with higher scores indicating greater sleepiness.
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Daily from day 1 to day 14
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Erik Nook, PhD, Princeton University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 15734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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