ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02510898
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Resilience Behavioral: 6-week Writing to Heal course Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining the Role of Expressive Writing (EW) to Improve Resilience Among Those Experiencing an Emotional Upheaval or a Physical Health Challenge
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Intervention Arm
All subjects enrolled in the study will receive the intervention. This is a one-arm study.
Behavioral: 6-week Writing to Heal course

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.





Primary Outcome Measures :
  1. Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. 10-Item Perceived Stress Scale (PSS-10) [ Time Frame: 6 weeks ]
  2. 20-item Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: 6 weeks ]
  3. 22-item Rumination Response Scale (RRS) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  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).

    a. 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

  3. They are able to read and write in English.
  4. They are able to attend 6 weekly sessions of the Transform Your Health: Write to Heal course held at Duke Integrative Medicine.
  5. They are able and willing to provide informed consent.

Exclusion Criteria:

  1. They are NOT at least 18 years of age.
  2. 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).
  3. They are NOT able to read and write in English.
  4. They are NOT able to attend 6 weekly sessions of the Transform Your Health: Write to Heal course held at Duke Integrative Medicine.
  5. They are NOT able and willing to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510898


Locations
United States, North Carolina
Duke Integrative Medicine
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Adam Perlman, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02510898     History of Changes
Other Study ID Numbers: Pro00062054
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: January 2016