Positive AffectSTEP YANCT06621992
Skills to Enhance Positivity in Young Adults
A study testing Skills to Enhance Positivity and Treatment as Usual in people with Positive Affect and Mindfulness, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The goal of this study is to test the feasibility and acceptability of a positive affect intervention for suicide in a population of young adults. Skills to Enhance Positivity (STEP) has been demonstrated to be feasible and acceptable among adolescents when delivered individually. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Positive Affect, Mindfulness, Gratitude
- What is being tested?
- Skills to Enhance Positivity and Treatment as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jul 2019
- 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 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must have a recent history of depression and are English-speaking
- Participants also must have a cell phone with text-messaging capabilities
Who cannot join
- Participants who have acute psychotic disorders or cognitive deficits that would preclude full understanding of the protocol, intervention and assessment materials
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
The goal of this study is to test the feasibility and acceptability of a positive affect intervention for suicide in a population of young adults. Skills to Enhance Positivity (STEP) has been demonstrated to be feasible and acceptable among adolescents when delivered individually. The current study aims to test feasibility and acceptability in a group setting of young adults. The specific aims of STEP also seek to establish whether participants who received STEP report a significant increase in attention towards positive affect compared to those receiving Treatment As Usual (TAU). They also seek to explore whether participants who received STEP will report a significant decrease in suicidal ideation and depression compared to those receiving TAU. The final aim is to explore whether an increase in attention to positive affect regardless of condition is a potential mechanism of change for reductions in suicidal ideation and depression. Participants will be randomized into STEP or TAU groups, they will complete baseline and follow-up assessments after a period of 3-months. Participants enrolled in STEP will receive in-person group sessions focusing on psychoeducation of positive affect as well as skills in mindfulness, gratitude and savoring designed to promote positive affect. After completing the group sessions they will also receive text messages for one month, where they will receive prompts to practice skills they learned in the group setting.
- Conditions
- Positive Affect, Mindfulness, Gratitude, Savoring, Depression
- Being tested
- Skills to Enhance Positivity, Treatment as Usual
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills to Enhance PositivityOther
Treatment as UsualOther
Participants received treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Skills to Enhance Positivity | Experimental | Participants received 4 group sessions, session 1 focused on positive affect psychoeducation, session 2 on mindfulness, 3 on savoring and 4 on gratitude. Once completing the group sessions participants received text messages for 1 month before tapering off. Receives: Other: Skills to Enhance Positivity |
| Treatment as Usual | Active comparator | Participants received their standard treatment as usual Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability of a group intervention
Feasibility and acceptability will be evaluated using self-report questionnaires and interviews
Measured: Will be assessed at follow-up at 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startDec 2016
- Primary completionJul 2019
- Study completionJul 2019
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 Positive AffectStudies of the same condition, open and under way.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621992
- Sponsor's protocol ID
- 016816
- Acronym
- STEP YA
- Status last verified
- Aug 2024
- First submitted
- 30 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request to Principal Investigator
Publications
Tezanos KM, Macrynikola N, Villareal L, Doerr J, Suazo N, Whiteley L, Yen S. A pilot randomized clinical trial of the Skills to Enhance Positivity (STEP) group intervention for young adults with depression: Examining feasibility and acceptability. PLoS One. 2026 Jun 10;21(6):e0350008. doi: 10.1371/journal.pone.0350008. eCollection 2026.
PubMed 42268843
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills to Enhance Positivity in Young Adults
- ClinicalTrials.gov ID
- NCT06621992
- Acronym / sponsor ID
- STEP YA / 016816
- Conditions
- Positive Affect, Mindfulness, Gratitude, Savoring, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 1 Oct 2024 (actual)
- 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.
The goal of this study is to test the feasibility and acceptability of a positive affect intervention for suicide in a population of young adults. Skills to Enhance Positivity (STEP) has been demonstrated to be feasible and acceptable among adolescents when delivered individually. The current study aims to test feasibility and acceptability in a group setting of young adults. The specific aims of STEP also seek to establish whether participants who received STEP report a significant increase in attention towards positive affect compared to those receiving Treatment As Usual (TAU). They also seek to explore whether participants who received STEP will report a significant decrease in suicidal ideation and depression compared to those receiving TAU. The final aim is to explore whether an increase in attention to positive affect regardless of condition is a potential mechanism of change for reductions in suicidal ideation and depression. Participants will be randomized into STEP or TAU groups, they will complete baseline and follow-up assessments after a period of 3-months. Participants enrolled in STEP will receive in-person group sessions focusing on psychoeducation of positive affect as well as skills in mindfulness, gratitude and savoring designed to promote positive affect. After completing the group sessions they will also receive text messages for one month, where they will receive prompts to practice skills they learned in the group setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skills to Enhance Positivity | Experimental | Other: Skills to Enhance PositivityParticipants received 4 group sessions, session 1 focused on positive affect psychoeducation, session 2 on mindfulness, 3 on savoring and 4 on gratitude. Once completing the group sessions participants received text messages for 1 month before tapering off. |
| Treatment as Usual | Active comparator | Other: Treatment as UsualParticipants received their standard treatment as usual |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must have a recent history of depression and are English-speaking
- Participants also must have a cell phone with text-messaging capabilities
Key exclusion criteria (1 listed)
- Participants who have acute psychotic disorders or cognitive deficits that would preclude full understanding of the protocol, intervention and assessment materials
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 |
|---|---|---|
| Skills to Enhance Positivity | Other | Skills to Enhance Positivity |
| Treatment as UsualParticipants received treatment as usual | Other | Treatment as Usual |
Primary outcome
Feasibility and Acceptability of a group intervention
Time frame: Will be assessed at follow-up at 3-months
Feasibility and acceptability will be evaluated using self-report questionnaires and interviews
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 1 Oct 2024.
- Derived from this study: PubMed 42268843Tezanos KM, Macrynikola N, Villareal L, Doerr J, Suazo N, Whiteley L, Yen S. A pilot randomized clinical trial of the Skills to Enhance Positivity (STEP) group intervention for young adults with depression: Examining feasibility and acceptability. PLoS One. 2026 Jun 10;21(6):e0350008. doi: 10.1371/journal.pone.0350008. eCollection 2026.
- Individual participant dataSharing planned: Yes. Upon request to Principal Investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills to Enhance Positivity and Treatment as Usual in people with Positive Affect and Mindfulness, run by Rhode Island Hospital 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 2 inclusion and 1 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 1 Oct 2024. 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?
Feasibility and Acceptability of a group intervention (time frame: Will be assessed at follow-up at 3-months). 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 NCT06621992, 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 1 Oct 2024.