Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms?

Depression Clinical Trial

Official title:

Decreasing Depressive Symptoms Through a Derailment-Focused Reflective Journaling Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06265701
• Other study ID #: IRB0148200
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2024
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The population will consist of those who: are considered as emergent adults (18-29 years) with at least moderate to severe depressive symptoms (a score of at least 20 on the BDI-II), moderate anxiety symptoms (a score of at least 10 on the GAD-7), and high levels of derailment (a score of at least 37 on the Derailment Scale).

Main research questions are as follows:

• Does the "Me Through Time" journaling intervention predict decreased derailment and depressive symptoms at post-assessment compared to the severity of pre-assessment derailment and depressive symptoms?

• Are post-assessment derailment and depressive symptoms lower for those who engaged in the "Me Through Time" journaling intervention compared to a control journaling intervention?

Participants will be asked to complete structured journal entries over the course of 5 sessions over 2 weeks, whereby each session addresses a different critical time period. These include: (1) first semester of college, (2) high school years, (3) middle school years, (4) early childhood, and finally (5) desired future. Participants will also be tasked with completing several assessment scales both before and after completing the "Me Through Time" journaling experience, as well as at the midway point.

The investigators will compare an experimental group engaging in the novel, derailment-focused "Me Through Time" journaling intervention with a control group engaging in a neutral, non-identity-based reflective journaling activity spanning the same time period as the "Me Through Time" intervention to see if post-assessment derailment and depressive symptoms are lower for those who engaged in the "Me Through Time" journaling intervention compared to the control journaling intervention.

The investigators hypothesize that those in the experimental condition will endorse significantly lower derailment and depressive symptoms at T2 than those in the control condition. Further, the investigators hypothesize significant decreases in T1 to T2 depressive symptoms and derailment for those in the experimental condition, but not in the control condition.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: March 12, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Derailment-Focused Reflective Journaling
Experimental group aimed at decreasing anxiety symptoms

Other:
• Everyday Tasks Reflective Journaling
Control group

Locations

Country	Name	City	State
United States	Cornell University	Ithaca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment)	The Generalized Anxiety Disorder 7-item is a validated, self-reported instrument that is used to assess symptoms of anxiety based on the generalized anxiety disorder diagnostic criteria described in the Diagnostic and Statistical Manual of Mental Disorders. Possible scores range from 0 to 21, whereby higher score indicate higher levels of anxiety symptoms. Specifically, a raw score of 0-4 is considered minimal range, 5-9 is mild, 10-14 is moderate, and 15-21 is severe.	Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
Secondary	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)	The Positive and Negative Affect Schedule is a validated, self-reported instrument that is used to measure mood and emotion, specifically positive affect and negative affect. It contains 20 items, 10 of which measure positive affect (e.g., excited, inspired) and the other 10 of which measure negative affect (e.g., upset, afraid). One's score on this instrument is separated into Positive Affect and Negative Affect scores, with a higher score indicating more positive or negative affect, respectively. Scores for both Positive Affect and Negative Affect Scores can range from 10-50.	Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
Secondary	Change from Pre-Assessment in Levels of Perceived Stress on the Perceived Stress Scale (PSS) at Week 2 (Session 6/Post-Assessment)	The Perceived Stress Scale is a validated, 10-item self-reported instrument that measures the perception of stress; that is, it is a measure of the degree to which situations in one's life are appraised as stressful. Possible scores range from 0-40, with higher scores representing higher levels of stress.	Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
Secondary	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	The Life Orientation Test - Revised is a validated, 10-item self-reported instrument that is used to measure individual differences in optimism versus pessimism. Negatively worded items (Items 3, 7, and 9) are reverse coded before scoring. Responses to these items are then summed with the participant's responses to Items 1, 4, and 10 to compute an overall optimism score. Items 2, 5, 6, and 8 are fillers and should not be scored. Thus, scores on this instrument range from 0 to 24, whereby lower scores indicate lower optimism (higher pessimism) and higher scores indicate higher optimism (lower pessimism).	Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)