Skills to Enhance Positivity in Young Adults

NCT06621992 | Completed DMC

• 1 other identifier: 016816
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Feasibility and Acceptability of a group intervention

  Feasibility and acceptability will be evaluated using self-report questionnaires and interviews

  Will be assessed at follow-up at 3-months

Study Arms (2)

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.

Other: Skills to Enhance Positivity

Treatment as Usual

ACTIVE COMPARATOR

Participants received their standard treatment as usual

Other: Treatment as Usual

Interventions

Skills to Enhance Positivity OTHER

Skills to Enhance Positivity

Treatment as Usual OTHER

Participants received treatment as usual

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 1, 2024
• Study Start: December 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 1, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request
• Access Criteria: Upon request

Locations

US (1)