NCT01873599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

June 5, 2013

Last Update Submit

July 9, 2014

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • National Health Interview Survey

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

    3 month follow up

Secondary Outcomes (7)

  • Brief Resilience Scale

    3 month follow up

  • Perceived Stress Scale

    3 month follow up

  • Satisfaction with Life scale

    3 month follow up

  • Social Provisions Scale

    3 month follow up

  • Healthy Days score

    3 month follow up

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Positive Affect JournalingBEHAVIORAL
Intervention

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • 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.

    PMID: 30530460DERIVED

Study Officials

  • Christopher Sciamanna

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of General Internal Medicine

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 10, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

US(1)