Clinical trial NCT06265701: Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms?
Official title: Decreasing Depressive Symptoms Through a Derailment-Focused Reflective Journaling Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Symptoms
Derailment
Anxiety
Keywords: Depression
Identity Continuity
Randomized Control Trial
Journaling
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment)
timeFrame: Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
measure: Change from Pre-Assessment in Levels of Derailment on the Derailment Scale at Session 5
timeFrame: Pre-Assessment (Baseline) and Session 5
Secondary outcomes:
measure: Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment)
timeFrame: Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
measure: 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)
timeFrame: Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
measure: Change from Pre-Assessment in Levels of Perceived Stress on the Perceived Stress Scale (PSS) at Week 2 (Session 6/Post-Assessment)
timeFrame: Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
measure: 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
timeFrame: Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
Study officials:
References: