Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms?

NCT06265701 | Completed

• 1 other identifier: IRB0148200
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the efficacy of a reflective journaling intervention-"Me Through Time"- in decreasing levels of derailment, and its impact on downstream depressive symptoms.

Conditions

Depression; Depressive Symptoms; Derailment; Anxiety

Keywords

Depression; Identity Continuity; Randomized Control Trial; Journaling

Outcome Measures

Primary Outcomes (2)

• Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment)

  The Beck Depression Inventory II is a validated, 21-item self-reported instrument assessing the severity of depression symptomatology in adolescents and adults. Items are summed to create a total score, whereby higher scores indicate higher levels of depressive symptoms. Scores range from 0-63, and a total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

  Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)

• Change from Pre-Assessment in Levels of Derailment on the Derailment Scale at Session 5

  The Derailment Scale is a validated, 10-item self-reported instrument that measures one's level of derailment - that is, one's perceptions of global change in self and direction. Possible scores range from 10-50, whereby higher scores indicate higher levels of derailment.

  Pre-Assessment (Baseline) and Session 5

Secondary Outcomes (4)

• Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment)

  Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)

• Change from Pre-Assessment in Levels of Positive and Negative Affect on the Positive and Negative Affect Schedule (PANAS) at Week 2 (Session 6/Post-Assessment)

  Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)

• Change from Pre-Assessment in Levels of Perceived Stress on the Perceived Stress Scale (PSS) at Week 2 (Session 6/Post-Assessment)

  Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)

• Change from Pre-Assessment in Levels of Optimism Versus Pessimism on the Life Orientation Test - Revised (LOT - Revised) at Week 2 (Session 6/Post-Assessment

  Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)

Study Arms (2)

Derailment-Focused Reflective Journaling Condition

EXPERIMENTAL

Participants will be tasked with engaging in a 5-session journaling intervention where participants reflect on core aspects about their (participants') selves within traditional developmental stages (e.g., first semester in college, early childhood, etc.).

Behavioral: Derailment-Focused Reflective Journaling

Everyday Tasks Reflective Journaling Condition

PLACEBO COMPARATOR

Participants will be tasked with engaging in a 5-session journaling intervention where they (participants) reflect on everyday tasks (e.g., their last trip to the grocery store, the last movie they saw, etc.).

Other: Everyday Tasks Reflective Journaling

Interventions

Derailment-Focused Reflective Journaling BEHAVIORAL

Experimental group aimed at decreasing anxiety symptoms

Derailment-Focused Reflective Journaling Condition

Everyday Tasks Reflective Journaling OTHER

Control group

Everyday Tasks Reflective Journaling Condition

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be aged 18-29.
• Participants must be fluent in English.
• Participants must have attended at least one semester of college.
• Participants must live in the United States
• Participants must have a score on the Derailment Scale of at least 37 at pre-assessment.
• Participants must have a score on the Beck Depression Inventory II of at least 20 at pre- assessment.
• Participants must have a score on the GAD-7 of at least 10 at pre-assessment.
• Participants must be willing and able to engage in a 2-week reflective journaling experience.

You may not qualify if:

• Those outside of the specified age range.
• Those who are not fluent in English.
• Those who have not attended at least one semester of college.
• Those who do not live in the United States.
• Those who have a score on the Derailment Scale of less than 37 at pre-assessment.
• Those have a score on the Beck Depression Inventory II of less than 20 at pre- assessment.
• Those who have a score on the GAD-7 of less than 10 at pre-assessment.
• Those who are neither willing nor able to engage in a 2-week reflective journaling experience.

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Cornell University

Ithaca, New York, 14850, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Investigators will utilize a single-blind approach where participants will not be made aware of the purpose of the intervention. Participants in both arms will be told that the purpose of the study is "to determine the efficacy of a novel five-session journaling intervention, which explores concepts related to self-continuity". This is partly true for those in the experimental arm. The main purpose of the study is twofold: (1) to explore the efficacy of the experimental journaling intervention's in reducing levels of derailment and (2) to test the hypothesis that decreasing derailment- a temporal discordance of the self- will lead to a decrease in depressive symptoms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: February 15, 2024
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)