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.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Behavioral: Positive Affect Journaling

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Penn State University
• Investigators: Principal Investigator: Christopher Sciamanna, Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• Smyth JM, Johnson JA, Auer BJ, Lehman E, Talamo G, Sciamanna CN. Online Positive Affect Journaling in the Improvement of Mental Distress and Well-Being in General Medical Patients With Elevated Anxiety Symptoms: A Preliminary Randomized Controlled Trial. JMIR Ment Health. 2018 Dec 10;5(4):e11290. doi: 10.2196/11290.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: June 5, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 41160EP