NCT02510898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

July 28, 2015

Last Update Submit

March 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Connor-Davidson Resilience Scale (CD-RISC)

    6 weeks

Secondary Outcomes (3)

  • 10-Item Perceived Stress Scale (PSS-10)

    6 weeks

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

    6 weeks

  • 22-item Rumination Response Scale (RRS)

    6 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

All subjects enrolled in the study will receive the intervention. This is a one-arm study.

Behavioral: 6-week Writing to Heal course

Interventions

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.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Integrative Medicine

Durham, North Carolina, 27705, United States

Location

Study Officials

  • Adam Perlman, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

July 29, 2015

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations