StressNCT01873599
Impact of an Online Positive Affect Journaling Intervention
A study testing Positive Affect Journaling in people with Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stress
- What is being tested?
- Positive Affect Journaling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
- Conditions
- Stress
- Being tested
- Positive Affect Journaling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Affect JournalingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Health Interview Survey
The NHIS measures perceived levels of stress over the past 12 months.
Measured: 3 month follow up
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
- Investigators
- Christopher Sciamanna, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873599
- Sponsor's protocol ID
- 41160EP
- Status last verified
- Jul 2014
- First submitted
- 5 Jun 2013
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30530460
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Online Positive Affect Journaling Intervention
- ClinicalTrials.gov ID
- NCT01873599
- Acronym / sponsor ID
- 41160EP
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Positive Affect JournalingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Affect Journaling | Behavioural | Intervention |
Primary outcome
National Health Interview Survey
Time frame: 3 month follow up
The NHIS measures perceived levels of stress over the past 12 months.
7 secondary outcomes
Brief Resilience Scale
Time frame: 3 month follow up
Perceived Stress Scale
Time frame: 3 month follow up
Satisfaction with Life scale
Time frame: 3 month follow up
Social Provisions Scale
Time frame: 3 month follow up
Healthy Days score
Time frame: 3 month follow up
Positive and Negative Affect Schedule score
Time frame: 3 month follow up
Cancer Quality of Life
Time frame: 3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Derived from this study: PubMed 30530460Smyth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Sciamanna principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Affect Journaling in people with Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Health Interview Survey (time frame: 3 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01873599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.