- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05234476
Behavioral Activation Plus Savoring for University Students
February 15, 2022 updated by: Southern Methodist University
A Randomized Controlled Trial of Behavioral Activation Plus Savoring for University Students With Positive Valence Dysregulation
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
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 Contact
- Name: Divya Kumar, M.A.
- Phone Number: 2147681767
- Email: divyak@smu.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75206
- Recruiting
- Southern Methodist University
-
Contact:
- Divya Kumar
- Phone Number: 972-953-9445
- Email: divyak@smu.edu
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- University student
- Own a smartphone
- Positive affect score less than 32 on the Positive and Negative Affect Schedule, Short Form (PANAS-SF)
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral Activation plus Savoring
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 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.
|
Active Comparator: Empathic Listening
Individuals in the active control condition will complete two sessions of reflecting on tracking their mood and empathic listening 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Emotions: Modified Differential Emotions Scale (mDES; Fredrickson et al., 2003)
Time Frame: Change from first session to post-treatment (14 days)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive and Negative Affect Schedule (PANAS)
Time Frame: Change from baseline to post-treatment (21 days)
|
Change in reported symptoms of positive and negative affect following the intervention
|
Change from baseline to post-treatment (21 days)
|
Depression, Anxiety, and Stress Scale (DASS-21)
Time Frame: Change from baseline to post-treatment (21 days)
|
Change in self-reported symptoms of depression, anxiety, and stress following the intervention
|
Change from baseline to post-treatment (21 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 6, 2021
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
October 8, 2021
First Submitted That Met QC Criteria
February 1, 2022
First Posted (Actual)
February 10, 2022
Study Record Updates
Last Update Posted (Actual)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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