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Impact of an Online Positive Affect Journaling Intervention

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ClinicalTrials.gov Identifier: NCT01873599
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : July 10, 2014
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

Brief Summary:
In this study the investigators plan to recruit 70 patients reporting high levels of stress to test the impact of Positive Affect Journaling. Patients randomized to use the online intervention will be asked to journal about one of seven topics, several days each week, for three months. The topics (e.g., "What went well") are designed to help the individual focus on some positive aspect of their life or themselves over the past day. Each topic is based on prompts shown to be effective in studies of up to one week in duration. In the summer of 2012, our research team pilot tested each prompt with 20 patients with high levels of anxiety, which led to important changes to the prompts, to increase their potential impact. The main aim is to understand the impact of Positive Affect Journaling on psychological distress, as measured by the National Health Interview Survey.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Positive Affect Journaling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of an Online Positive Affect Journaling Intervention
Study Start Date : June 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: Intervention
Participants in the intervention condition will be asked to write for 15 minutes on three days each week to one of the seven positive affect writing prompts on www.stressvax.com. Subjects who do not complete a journal entry within 7 days will receive an email reminder, in case they have lost their password or have some technical problem accessing the site.
Behavioral: Positive Affect Journaling
No Intervention: Control
As there is no clinical standard of care treatment for psychological distress, patients randomized into this condition will receive their usual care. At the end of three months, subjects in this condition will be given access to the positive affect journaling intervention.



Primary Outcome Measures :
  1. National Health Interview Survey [ Time Frame: 3 month follow up ]
    The NHIS measures perceived levels of stress over the past 12 months.


Secondary Outcome Measures :
  1. Brief Resilience Scale [ Time Frame: 3 month follow up ]
    The BRS is a 6-item self-report measure of perceived resilience, including items such as "It does not take me long to recover from a stressful event" The BRS has high levels of internal consistency, with Cronbach's alpha ranging from .80-.91

  2. Perceived Stress Scale [ Time Frame: 3 month follow up ]
    The PSS consists of 10 items that assess perceived stress. The items are scored on a 4-point scale (45). The measure demonstrates strong internal consistency with a Cronbach's alpha of .88

  3. Satisfaction with Life scale [ Time Frame: 3 month follow up ]
    The SWL is a five-item scale that assesses overall life satisfaction. The SWL has a 2-month test-retest reliability of 0.82 and a Cronbach's alpha of 0.87

  4. Social Provisions Scale [ Time Frame: 3 month follow up ]
    The SPS assesses the extent to which one perceives their social relationships to be supportive. This 24-item measure has a Cronbach's alpha of 0.91

  5. Healthy Days score [ Time Frame: 3 month follow up ]
    Created by the Centers for Disease Control, this measure assesses the number of days of poor mental health, physical health, poor sleep and other symptoms, as well as overall health

  6. Positive and Negative Affect Schedule score [ Time Frame: 3 month follow up ]
    The 20-item PANAS consists of two subscales, in which respondents indicate the extent to which they felt specific positive and negative emotions over a specific time frame. Internal consistencies are high (Crohnbach's alpha = 0.85-0.88)

  7. Cancer Quality of Life [ Time Frame: 3 month follow up ]
    The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fluently speaks, writes, and read English
  • Report elevated levels of stress
  • Be between 21-80 years of age
  • Have access to the Internet
  • Have an ECOG Performance Status of 0 (Fully active) through 3 (Limited self-care)

Exclusion Criteria:

  • High risk for suicidality on the Structured Clinical Interview for DSM Disorders (SCID).
  • Pregnant or planning to get pregnant in the next 3 months
  • Moving in the next 6 months

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): NCT01873599


Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Penn State University
Investigators
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Principal Investigator: Christopher Sciamanna Milton S. Hershey Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christopher Sciamanna, MD, MPH, Chief, Division of General Internal Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01873599     History of Changes
Other Study ID Numbers: 41160EP
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014