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Behavioral Activation Plus Savoring for University Students

Primary Purpose

Mood, Anhedonia, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation plus Savoring
Empathic Listening
Sponsored by
Southern Methodist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • Southern Methodist UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Activation plus Savoring

Empathic Listening

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Positive and Negative Affect Schedule (PANAS)
Change in reported symptoms of positive and negative affect following the intervention
Depression, Anxiety, and Stress Scale (DASS-21)
Change in self-reported symptoms of depression, anxiety, and stress following the intervention

Full Information

First Posted
October 8, 2021
Last Updated
February 15, 2022
Sponsor
Southern Methodist University
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1. Study Identification

Unique Protocol Identification Number
NCT05234476
Brief Title
Behavioral Activation Plus Savoring for University Students
Official Title
A Randomized Controlled Trial of Behavioral Activation Plus Savoring for University Students With Positive Valence Dysregulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Methodist University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Experiences of positive emotions are often unchanged following standard psychotherapy. To address this, the current investigation aims to enhance traditional brief behavioral activation with savoring, an emotion regulation strategy specifically targeting positive emotion, or affect, for university students endorsing low levels of the symptom. Individuals will be randomized to either a two-session behavioral activation plus savoring intervention or two sessions of empathic listening. Daily levels of positive emotions will be assessed throughout the study and for one week prior to and completing the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood, Anhedonia, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Activation plus Savoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Empathic Listening
Arm Type
Active Comparator
Arm Description
Individuals in the active control condition will complete two sessions of reflecting on tracking their mood and empathic listening with a study therapist.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation plus Savoring
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Empathic Listening
Intervention Description
Individuals in the active control condition will complete two sessions of reflecting on tracking their mood and empathic listening with a study therapist.
Primary Outcome Measure Information:
Title
Positive Emotions: Modified Differential Emotions Scale (mDES; Fredrickson et al., 2003)
Description
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.
Time Frame
Change from first session to post-treatment (14 days)
Secondary Outcome Measure Information:
Title
Positive and Negative Affect Schedule (PANAS)
Description
Change in reported symptoms of positive and negative affect following the intervention
Time Frame
Change from baseline to post-treatment (21 days)
Title
Depression, Anxiety, and Stress Scale (DASS-21)
Description
Change in self-reported symptoms of depression, anxiety, and stress following the intervention
Time Frame
Change from baseline to post-treatment (21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: University student Own a smartphone Positive affect score less than 32 on the Positive and Negative Affect Schedule, Short Form (PANAS-SF)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Divya Kumar, M.A.
Phone
2147681767
Email
divyak@smu.edu
Facility Information:
Facility Name
Southern Methodist University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Divya Kumar
Phone
972-953-9445
Email
divyak@smu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Behavioral Activation Plus Savoring for University Students

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