DepressionNCT06265701
Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms?
A study testing Derailment-Focused Reflective Journaling and Everyday Tasks Reflective Journaling in people with Depression and Depressive Symptoms, run by Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Depression, Depressive Symptoms, Derailment
- What is being tested?
- Derailment-Focused Reflective Journaling and Everyday Tasks Reflective Journaling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreasing Depressive Symptoms Through a Derailment-Focused Reflective Journaling Intervention
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.
Read the 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.
- Conditions
- Depression, Depressive Symptoms, Derailment, Anxiety
- Being tested
- Derailment-Focused Reflective Journaling, Everyday Tasks Reflective Journaling
- Keywords
- Depression, Identity Continuity, Randomized Control Trial, Journaling
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Derailment-Focused Reflective JournalingBehavioural
Experimental group aimed at decreasing anxiety symptoms
Everyday Tasks Reflective JournalingOther
Control group
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: 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.). Receives: Other: Everyday Tasks Reflective Journaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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).
Measured: Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Feb 2024
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265701
- Sponsor's protocol ID
- IRB0148200
- Status last verified
- Oct 2024
- First submitted
- 12 Feb 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Depressive Symptoms Through a Derailment-Focused Reflective Journaling Intervention
- ClinicalTrials.gov ID
- NCT06265701
- Acronym / sponsor ID
- IRB0148200
- Conditions
- Depression, Depressive Symptoms, Derailment, Anxiety
- Keywords
- Depression, Identity Continuity, Randomized Control Trial, Journaling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derailment-Focused Reflective Journaling Condition | Experimental | Behavioral: Derailment-Focused Reflective JournalingParticipants 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.). |
| Everyday Tasks Reflective Journaling Condition | Placebo comparator | Other: Everyday Tasks Reflective JournalingParticipants 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.). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Derailment-Focused Reflective JournalingExperimental group aimed at decreasing anxiety symptoms | Behavioural | Derailment-Focused Reflective Journaling Condition |
| Everyday Tasks Reflective JournalingControl group | Other | Everyday Tasks Reflective Journaling Condition |
Primary outcome
Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment)
Time frame: Baseline (Pre-Assessment) and 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.
Change from Pre-Assessment in Levels of Derailment on the Derailment Scale at Session 5
Time frame: Pre-Assessment (Baseline) and 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.
4 secondary outcomes
Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Derailment-Focused Reflective Journaling and Everyday Tasks Reflective Journaling in people with Depression and Depressive Symptoms, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment) (time frame: Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.