MoodNCT05234476
Behavioral Activation Plus Savoring for University Students
A study testing Behavioral Activation plus Savoring and Empathic Listening in people with Mood and Anhedonia, run by Southern Methodist University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood, Anhedonia, Depression
- What is being tested?
- Behavioral Activation plus Savoring and Empathic Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University student
- Own a smartphone
- Positive affect score less than 32 on the Positive and Negative Affect Schedule, Short Form (PANAS-SF)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southern Methodist University
Dallas, Texas, 75206
Divya Kumar, 972-953-9445, divyak@smu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Mood, Anhedonia, Depression
- Being tested
- Behavioral Activation plus Savoring, Empathic Listening
- Medical subject headings
- Anhedonia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation plus SavoringBehavioural
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.
Empathic ListeningBehavioural
Individuals in the active control condition will complete two sessions of reflecting on tracking their mood and empathic listening with a study therapist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Empathic Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from first session to post-treatment (14 days)
Secondary outcomes (2)
Positive and Negative Affect Schedule (PANAS)
Change in reported symptoms of positive and negative affect following the intervention
Measured: Change from baseline to post-treatment (21 days)
Depression, Anxiety, and Stress Scale (DASS-21)
Change in self-reported symptoms of depression, anxiety, and stress following the intervention
Measured: Change from baseline to post-treatment (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start6 Sep 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234476
- Sponsor's protocol ID
- 21-118
- Status last verified
- Feb 2022
- First submitted
- 8 Oct 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38653177
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Behavioral Activation Plus Savoring for University Students With Positive Valence Dysregulation
- ClinicalTrials.gov ID
- NCT05234476
- Acronym / sponsor ID
- 21-118
- Conditions
- Mood, Anhedonia, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation plus Savoring | Experimental | Behavioral: Behavioral Activation plus SavoringIndividuals 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. |
| Empathic Listening | Active comparator | Behavioral: Empathic ListeningIndividuals in the active control condition will complete two sessions of reflecting on tracking their mood and empathic listening with a study therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- University student
- Own a smartphone
- Positive affect score less than 32 on the Positive and Negative Affect Schedule, Short Form (PANAS-SF)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation plus SavoringIndividuals 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. | Behavioural | Behavioral Activation plus Savoring |
| Empathic ListeningIndividuals in the active control condition will complete two sessions of reflecting on tracking their mood and empathic listening with a study therapist. | Behavioural | Empathic Listening |
Primary outcome
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.
2 secondary outcomes
Positive and Negative Affect Schedule (PANAS)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Derived from this study: PubMed 38653177Kumar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation plus Savoring and Empathic Listening in people with Mood and Anhedonia, run by Southern Methodist University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Divya Kumar, M.A. (2147681767, divyak@smu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Emotions: Modified Differential Emotions Scale (mDES; Fredrickson et al., 2003) (time frame: Change from first session to post-treatment (14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05234476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.