NCT05234476

Brief Summary

The current investigation aims to examine whether a brief, two-session, virtual behavioral activation plus savoring intervention will increase daily positive emotion in university students.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 6, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

October 8, 2021

Last Update Submit

February 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Positive Emotions: Modified Differential Emotions Scale (mDES; Fredrickson et al., 2003)

    Positive mood, as measured by the mDES, will be collected two times a day. Participants will be asked to rate their level of positive mood in the moment. Positive mood will be collected on a daily basis throughout the study and change in reported positive emotions will be assessed.

    Change from first session to post-treatment (14 days)

Secondary Outcomes (2)

  • Positive and Negative Affect Schedule (PANAS)

    Change from baseline to post-treatment (21 days)

  • Depression, Anxiety, and Stress Scale (DASS-21)

    Change from baseline to post-treatment (21 days)

Study Arms (2)

Behavioral Activation plus Savoring

EXPERIMENTAL

Individuals in this intervention will complete two sessions of behavioral activation, where they will be provided psychoeducation on behavioral models of mood, schedule activities, and discuss barriers to completion. Additionally, they will practice savoring as a cognitive strategy to increase positive emotions with a study therapist.

Behavioral: Behavioral Activation plus Savoring

Empathic Listening

ACTIVE COMPARATOR

Individuals in the active control condition will complete two sessions of reflecting on tracking their mood and empathic listening with a study therapist.

Behavioral: Empathic Listening

Interventions

Individuals in this intervention will complete two sessions of behavioral activation, where they will be provided psychoeducation on behavioral models of mood, schedule activities, and discuss barriers to completion. Additionally, they will practice savoring as a cognitive strategy to increase positive emotions with a study therapist.

Behavioral Activation plus Savoring

Individuals in the active control condition will complete two sessions of reflecting on tracking their mood and empathic listening with a study therapist.

Empathic Listening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • University student
  • Own a smartphone
  • Positive affect score less than 32 on the Positive and Negative Affect Schedule, Short Form (PANAS-SF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75206, United States

RECRUITING

Related Publications (1)

  • Kumar D, Corner S, Kim R, Meuret A. A randomized controlled trial of brief behavioral activation plus savoring for positive affect dysregulation in university students. Behav Res Ther. 2024 Jun;177:104525. doi: 10.1016/j.brat.2024.104525. Epub 2024 Mar 24.

MeSH Terms

Conditions

AnhedoniaDepression

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Central Study Contacts

Divya Kumar, M.A.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2021

First Posted

February 10, 2022

Study Start

September 6, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations