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ResilienceNCT02510898

Examining the Role of Expressive Writing (EW) to Improve Resilience

A study testing 6-week Writing to Heal course in people with Resilience, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether a 6-week writing to heal seminar/workshop/class, Transform Your Life: Write to Heal, raises resilience scores as measured by the Connor-Davidson Resilience Scale for people who have recently experienced an emotional or physical trauma. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Resilience
What is being tested?
6-week Writing to Heal course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
Jan 2016to Apr 2016
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • They are at least 18 years of age.
  • They self-identify as having had a recent emotional upheaval or physical health challenge (within the past 12 months, but not within the past month).
  • Potential challenges include, but are not limited to: i. Death of spouse ii. Divorce iii. Marital separation iv. Death of a parent v. Job loss vi. Personal injury or critical illness vii. Death of a close personal friend viii. Retirement ix. Marriage x. Significant change in financial security
  • They are able to read and write in English.
  • They are able to attend 6 weekly sessions of the Transform Your Health: Write to Heal course held at Duke Integrative Medicine.
  • They are able and willing to provide informed consent.

Who cannot join

  • They are NOT at least 18 years of age.
  • They do NOT self-identify as having had a recent emotional upheaval or physical health challenge (within the past 12 months, but not within the past month).
  • They are NOT able to read and write in English.
  • They are NOT able to attend 6 weekly sessions of the Transform Your Health: Write to Heal course held at Duke Integrative Medicine.
  • They are NOT able and willing to provide informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke Integrative Medicine

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Examining the Role of Expressive Writing (EW) to Improve Resilience Among Those Experiencing an Emotional Upheaval or a Physical Health Challenge

The purpose of this study is to determine whether a 6-week writing to heal seminar/workshop/class, Transform Your Life: Write to Heal, raises resilience scores as measured by the Connor-Davidson Resilience Scale for people who have recently experienced an emotional or physical trauma.

Eligible subjects will be adults who self-identify as having had a recent emotional upheaval or physical health challenge. Potential subjects will be recruited through the use of flyers, advertisements, and emails to the Duke Integrative Medicine email list. Subjects will complete pen and paper measures at baseline and immediately post-treatment, including: the Connor-Davidson Resilience Scale, the 10-item Perceived Stress Scale, The 20-item Center for Epidemiological Studies Depression Scale, the 22-item Rumination Response Scale, and a baseline questionnaire.

The investigators aim to target a sample of 30 completers by enrolling 37 participants. The risks of participation in this study are minimal, and include temporary sadness after the initial writing experience.

Read the detailed description

Background The literature of several health care professions suggests that for many people, writing to heal is beneficial and useful for obtaining and sustaining emotional, physical, and spiritual health. Since the 1980s, a growing body of research shows that the heart rate lowers and people are more equipped to fight off infections when they release their worries in writing. In addition to demonstrating better coping with stressful situations, this research shows that writing can have a positive impact on self-esteem and result in helping people overcome their own obstacles.

Much of the research about writing and healing was pioneered by James Pennebaker, Ph.D., and is now sustained by others who work in the disciplines of writing, psychology, medicine, counseling, nursing, coaching, hospice and education. The biological underpinnings of writing for health are currently found in overlapping scientific areas such as: applied psychoneuorimmunology, psychobiology, applied psychophysiology and recent findings in epigenetics. Research about writing to heal, the kind of writing that is deeply personal and is written for one's own eyes only, demonstrates that such expressive writing:

  • Boosts thinking ability
  • Increases working memory
  • Reduces pain, tension, and fatigue
  • Enhances mood and sleep quality
  • Positively influences immune system function

Rationale A recent study suggests that writing to heal as part of a larger program may be useful in raising resilience for critical care nurses who have been shown to have lower than average resilience scores on the Connor-Davidson Resilience Scale (2014 Mealer, et.al). In Mealer's multi-modal study, subjects participated in a four hour writing to heal workshop and then wrote according to prescribed prompts once a week for the next twelve weeks. Subjects also participated in Mindfulness-Based Stress Reduction (MBSR) and an exercise program. Post-treatment scores on the CD Resilience Scale were higher for nearly all subjects in this study. However, the potential effect of the writing treatment alone is unclear. Therefore, the aim of this study is to isolate the effect of expressive writing on resilience among those who have experienced an emotional upheaval or a physical health challenge.

Objective: Obtain preliminary data that can be used for grant application addressing the following research question:

Does a 6-week writing to heal workshop, Transform Your Health: Write to Heal, raise resilience, as measured by the Connor-Davidson Resilience Scale for people who have experienced an emotional or physical trauma in the past 12 months?

Design This prospective, observational trial will examine the impact of the 6-week writing course on resilience scores as measured by the Connor-Davidson Resilience Scale (CD-Risc) in a 30-participant pilot trial.

Procedures Potential subjects will be recruited through the use of flyers, advertisements, and via emails to the Duke Integrative Medicine email list.

Potential subjects who call in response to the flyers or who express interest in the study via email will be contacted and screened over the phone by the study coordinator.

Potential subjects will be considered eligible if:

  1. They are at least 18 years of age.
  2. They self-identify as having had a recent emotional upheaval or physical health challenge (within the past 12 months, but not within the past month).
  3. Potential challenges include, but are not limited to: i. Death of spouse ii. Divorce iii. Marital separation iv. Death of a parent v. Job loss vi. Personal injury or critical illness vii. Death of a close personal friend viii. Retirement ix. Marriage x. Significant change in financial security
  4. They are able to read and write in English.
  5. They are able to attend 6 weekly sessions of the Transform Your Health: Write to Heal course held at Duke Integrative Medicine.
  6. They are able and willing to provide informed consent. The Transform Your Health: Write to Heal course for this study will be devoted entirely to research subjects, and will not be open to the general public.

A group informed consent will be administered by Duke Integrative Medicine staff (either the study coordinator or the principal investigator) during the first session of the course, before any study activities take place. Subjects will do baseline measures (baseline questionnaire, the Connor-Davidson Resilience scale, perceived stress scale, \& rumination scale) immediately after the consent.

The expected duration of the subjects' participation is 2 hours each week for 6 weeks, with the first and final classes being slightly longer. The first class in the series will be 2 hours and 30 minutes to allow time for the consent and baseline measures, and the final class will be 2 hours and 30 minutes to allow subjects time to take the post-treatment measures.

In order to have 30 evaluable subjects, using a typical 20% attrition rate for behavioral intervention studies, we plan to consent 37 subjects.

Measures Pen and paper measures will be collected at baseline and immediately post-treatment.

Primary outcome:

  1. Connor-Davidson Resilience Scale (CD-RISC): This 25-item scale addresses resilience, and has been studied in a variety of populations. Resilience is considered as the capacity to overcome adversity.

Secondary measures:

  1. Baseline questionnaire: This self-report questionnaire will gather basic sociodemographic information (i.e., gender, age, ethnicity, race, marital status, living situation, education). This questionnaire will be given at baseline only.
  2. 10-item Perceived Stress Scale (PSS-10): The PSS a well-known 10-item questionnaire used to evaluate responders' perceptions about their level of stress and their ability to cope with stress over the last month. Results from this questionnaire have demonstrated acceptable levels of validity and reliability. This inventory asks participants to respond using a 10-point Likert-type scale when endorsing the degree to which each item best reflects their thoughts and feelings within the past month (Cohen, Kamarck, \& Mermelstein, 1983).
  3. 20-item Center for Epidemiological Studies Depression Scale (CES-D): The CES-D is one of the most common screening tests that measures depressive feelings and behaviors within the past week. Almost 85% of those found to have depression after an in-depth structured interview with a psychiatrist will have a high score on the CES-D. However, about 20% of those who score high on the CES-D will have rapid resolution of their symptoms and not meet full criteria for major or clinical depression (Radloff, 1977).
  4. 22-item Rumination Response Scale (RRS): The RRS is questionnaire used to examine response styles for depression (Nolen-Hoeksema, 2003).

Compensation Subjects will receive the 6-week Transform Your Health: Write to Heal class at no cost. There is no monetary compensation for this study.

Curriculum During this 6-week class, an experienced writing-to-heal instructor will coach participants through a simple progression of writing exercises. Participation requires neither any prior writing experience nor any aspiration to become a writer. In fact, the practices cultivate participants' natural abilities to express the ideas that define who they are and how they experience their lives.

Weekly sessions build on previous sessions to provide a progression of experiences for participants to develop their natural styles of writing-to-heal. The instructor will guide participants through a variety of modes of writing that enhance health in different ways, including:

  1. Expressive Writing: moving beyond what you thought you could not get over. ii. Transactional Writing: communicating your desires with compassion, empathy, forgiveness and gratitude. iii. Poetic Writing: expressing your "rites of passage" with metaphor, story, poetry and creative nonfiction. iv. Affirmative Writing: discovering your gifts and describing your best possible life by writing it forward.
  2. Legacy Writing: sharing your values and the life lessons you have learned for those you love.

Data Analysis \& Statistical Considerations Given that the objective is to obtain pilot data for a future grant, we will target a sample of 30 completers by enrolling 37 participants. Relying on the tenets of the Central Limit Theorem and how scores on CD-RISC have behaved in other trials, we expect to have a fairly normal distribution of scores at both time points that will allow a simple dependent-measures t-test to estimate any change from pre to post intervention.

Discomforts and Risks The risks of participation in this study are minimal. Participants may experience a range of emotions, including sadness after the initial expressive writing experience. This is a common occurrence in this course and sadness is usually brief before negative mood lifts.

Potential Benefits Some participants who have taken the course have reported physical and emotional benefits, including a more balanced mood, increased ability to sleep, lower blood pressure, fewer symptoms of depression (Pennebaker \& Evans, 2014; Stockdale, 2011).

Confidentiality Every effort will be made to keep participants' information confidential. Subject study records will be assigned a unique code number, and the key to this code will be kept in a password-protected computer file in the principal investigator's or study coordinator's office until the completion of the study. All consent forms and questionnaire information will be stored separately in a locked file drawer in the study coordinator's office. All data considered sensitive electronic information will be stored on a DHTS network drive.

Additionally, participants' personal writing is not required to be shared and responses to the writing remain anonymous.

Conditions
Resilience
Being tested
6-week Writing to Heal course

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6-week Writing to Heal courseBehavioural

    During this 6-week class, a writing-to-heal instructor will coach participants through a simple progression of writing exercises. Participation requires neither any prior writing experience nor any aspiration to become a writer. In fact, the practices cultivate participants' natural abilities to express the ideas that define who they are and how they experience their lives.

    Weekly sessions build on previous sessions to provide a progression of experiences for participants to develop their natural styles of writing-to-heal. The instructor will guide participants through a variety of modes of writing that enhance health in different ways.

Study groups in NCT02510898
Study groupRoleWhat they receive
Intervention ArmExperimentalAll subjects enrolled in the study will receive the intervention. This is a one-arm study.
Receives: Behavioral: 6-week Writing to Heal course

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Connor-Davidson Resilience Scale (CD-RISC)

    Measured: 6 weeks

Secondary outcomes (3)
  1. 10-Item Perceived Stress Scale (PSS-10)

    Measured: 6 weeks

  2. 20-item Center for Epidemiological Studies Depression Scale (CES-D)

    Measured: 6 weeks

  3. 22-item Rumination Response Scale (RRS)

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionMar 2016
  4. Study completionApr 2016

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02510898
Sponsor's protocol ID
Pro00062054
Status last verified
Mar 2019
First submitted
28 Jul 2015
Last updated
12 Mar 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing 6-week Writing to Heal course in people with Resilience, run by Duke 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 6 inclusion and 5 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 12 Mar 2019. 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. 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?

Connor-Davidson Resilience Scale (CD-RISC) (time frame: 6 weeks). 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 12 Mar 2019.

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