Skills to Enhance Positivity in Young Adults (STEP YA)

September 30, 2024 updated by: Rhode Island Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants must have a recent history of depression and are English-speaking
  • Participants also must have a cell phone with text-messaging capabilities

Exclusion Criteria:

  • Participants who have acute psychotic disorders or cognitive deficits that would preclude full understanding of the protocol, intervention and assessment materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skills to Enhance Positivity
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.
Other: Skills to Enhance Positivity
Active Comparator: Treatment as Usual
Participants received their standard treatment as usual
Other: Treatment as Usual
Participants received treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Will be assessed at follow-up at 3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 016816

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request to Principal Investigator

IPD Sharing Time Frame

Upon request

IPD Sharing Access Criteria

Upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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