Impact of an Online Positive Affect Journaling Intervention

Stress Clinical Trial

Official title:

Impact of an Online Positive Affect Journaling Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873599
• Other study ID #: 41160EP
• Status: Completed
• Phase: N/A
• First received: June 5, 2013
• Last updated: July 9, 2014
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: July 2014
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Positive Affect Journaling

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Health Interview Survey	The NHIS measures perceived levels of stress over the past 12 months.	3 month follow up	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No