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Completed

NCT Number: NCT01873599

Impact of an Online Positive Affect Journaling Intervention

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.

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Key information

Conditions

Stress

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Affect Journaling

Behavioral

Primary outcomes

  1. National Health Interview Survey

    Time frame: 3 month follow up

    The NHIS measures perceived levels of stress over the past 12 months.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Penn State University

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2013
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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