Impact of an Online Positive Affect Journaling Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Impact of an Online Positive Affect Journaling Intervention

Conditions
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Stress

Intervention / Treatment
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* Behavioral: Positive Affect Journaling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br> <br> |
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Health Interview Survey | The NHIS measures perceived levels of stress over the past 12 months. | 3 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Resilience Scale | 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 | 3 month follow up | 
| Perceived Stress Scale | 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 month follow up | 
| Satisfaction with Life scale | 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 | 3 month follow up | 
| Social Provisions Scale | 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 | 3 month follow up | 
| Healthy Days score | 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 | 3 month follow up | 
| Positive and Negative Affect Schedule score | 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) | 3 month follow up | 
| Cancer Quality of Life | The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. | 3 month follow up |