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Oxford Social Movement Activation Study (SOMA)

Primary Purpose

Depression, Low Mood, Depressive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Salsa Dancing
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring low mood, depression, social movement, dance, salsa dance

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals aged 18 to 24 at time of eligibility screening; Competency to give informed consent; Individuals will *not* be excluded for a formal diagnosis of depression from a GP or other mental healthcare provider, nor for being presently or formerly on medication for depression; nor for presently or formerly attending talk therapies; Individuals who do not meet the exclusion criteria specified below. Exclusion Criteria: Individuals with a PHQ-9 score of less than 5 (indicating no low mood) or greater than 19 (indicating a low mood that could be too severe for this research); individuals who self-report a current or recent diagnosis of any psychotic disorder (e.g., bipolar, schizophrenia, schizoaffective disorder), substance use disorders, eating disorders, or personality disorders individuals who self-report that they are unfit for light physical exertion; individuals who regularly, or have regularly, attended partner dance classes or partner dance events within the last six months (as they would already be receiving the potential benefits we are investigating in this study); and individuals for whom the Principal Investigator determines that the study is not suitable.

Sites / Locations

  • University of Oxford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Salsa Dancing

Waitlist Control

Arm Description

Participants will complete eight weeks of a salsa course in Oxford (of which they need to attend six classes to remain in the study), followed by a one-month follow-up time point.

Participants will wait twelve weeks, completing the questionnaires and tasks at the same study time points as participants in the experimental condition.They will then be offered the opportunity to complete the eight-week salsa course. Should they choose to participate in the salsa course, they will additionally be offered the opportunity to complete questionnaires at two additional time points.

Outcomes

Primary Outcome Measures

Change in depressive symptoms from baseline at week four, eight, and twelve
Patient Health Questionnaire (PHQ-9) score. Higher scores indicate greater depressive symptoms.

Secondary Outcome Measures

Change in anxiety symptoms from baseline at week four, eight, and twelve
Generalized Anxiety Disorder Scale (GAD-7) score. Higher scores indicate greater anxiety.
Change in social anxiety symptoms from baseline at week four, eight, and twelve
Social Anxiety Scale - Adolescent (SAS-A) score. Higher scores indicate greater social anxiety.
Change in loneliness from baseline at week four, eight, and twelve
UCLA Loneliness Scale (+ Loneliness Question) score. Higher scores indicate more loneliness.
Change in daily mood questionnaire scores
Scoring one Likert scale mood questionnaire ("How happy do you feel?"), range 1-10. Higher values represent more happiness.
Change in social anhedonia from baseline at week four, eight, and twelve
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) score. Higher scores indicate lower social anhedonia.
Change in recognition of positive and negative facial expressions from baseline at week 8
Hit rate for detecting positive versus negative faces in a facial expression recognition task (FERT)
Change in speed during recognition of positive and negative facial expressions
Reaction times for correctly recognised positive versus negative faces in facial expression recognition task (FERT)
Change in emotional categorisation (ECAT)
Reaction times for correctly classifying positive versus negative personality characteristic words
Change in recall in the emotional recall task (EREC)
Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
Change in memory in the emotional memory task (EMEM)
Number of positive and negative words correctly (and incorrectly) recalled as familiar and novel
Change in trust behavior in the trust game (Trust Game)
Investment behavior and sensitivity to trustee's generosity when playing the role of the investor in a trust game

Full Information

First Posted
July 18, 2023
Last Updated
July 18, 2023
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT05963581
Brief Title
Oxford Social Movement Activation Study
Acronym
SOMA
Official Title
Investigating the Effects of Social Movement on Mood and Social and Emotional Functioning in Young People Experiencing Low Mood
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 17, 2023 (Anticipated)
Primary Completion Date
July 16, 2024 (Anticipated)
Study Completion Date
July 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

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

5. Study Description

Brief Summary
For adolescents and young people particularly, there is need for better and more readily available treatments for depression and low mood. Comparatively less work has been done to characterize and treat depression specifically in young people. Previous literature indicates that often the unaddressed or under-addressed mental health difficulties in youth perseverate into adulthood and contribute to a host of individual and communal difficulties throughout the lifespan (Layard & Clark, 2015). Specifically, if depression goes unaddressed in young adulthood, the likelihood of a chronic course and multiple relapses or recurrences is much higher (Saunders et al., 2021; Buckman et al., 2018). In the present research, we seek to investigate the potential efficacy of a novel intervention for young people with low mood. Depression disrupts social functioning, and social connectedness is especially important during adolescence for healthy development. Within a growing body of literature, social dance has been linked to social and mental health benefits along the dimensions of those disrupted in depression (Lakes et al., 2016; Shuper & Vulcan, 2021; Hyvönen et al., 2020). We hypothesize that social dance might preferentially and efficiently target the goals of addressing loneliness, closeness, and enjoyment in young people compared to other approaches to the treatment of low mood and depression in a way that could lead to mood improvements. Specifically, we are interested in the impact of a social movement-based activity, salsa dancing, on young peoples' mood and social and emotional processing. Social and emotional processing (SEP) tasks, such as emotional facial recognition and memory for emotional words, have been demonstrated to correspond with early changes that can be predictive of mood changes and treatment efficacy downstream (e.g., Harmer et al., 2017). Including SEP tasks in this research will help to elucidate the potential mechanisms underlying mood improvements, should social dance correspond to improved mood in participants. The present research seeks to: Aim 1: Investigate the effect of a social dance intervention on low mood. This will be assessed by administering psychological questionnaires to participants before, during, and after the study course of social dance sessions. In particular, we hypothesize that participants will experience reductions in low mood (assessed via the PHQ-9) following the social movement intervention as compared to a waitlist control. Aim 2: Characterize any early social and emotional processing changes that correspond to social dance versus a waitlist control. This will be assessed via social and emotional processing task performance before, during, and following the social movement sessions. We anticipate that improvements in social and emotional functioning as demonstrated via one or several of these tasks will assist in elucidating the possible mechanisms responsible for mood improvement from social movement. Aim 3: Characterize any social interaction difference from pre to post intervention that correspond to the social dance versus waitlist condition. This will be assessed via a version of the trust game before and following the social movement sessions and waitlist control. We anticipate seeing more disrupted trust behavior prior to the intervention or control conditions and less disrupted trust behavior following salsa dancing classes, but not the waitlist control. In this randomized controlled trial, participants in the experimental group will complete six to eight sessions of social movement (salsa dance) classes within an eight-week period, and complete psychological questionnaires and tasks before, during, and after these eight weeks. Their scores will be compared with those of a control group that will participate in an active waitlist condition. If the present study suggests that social movement benefits young people with low mood, it could form the basis for investigating a potential new cost-effective, non-invasive, accessible intervention that could be made available to young people.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Low Mood, Depressive Disorder, Mood Disorders, Depressive Symptoms
Keywords
low mood, depression, social movement, dance, salsa dance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to either the salsa dancing intervention (46 participants) or the passive waiting-list control group (46 participants). Randomization will be stratified by gender.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Salsa Dancing
Arm Type
Experimental
Arm Description
Participants will complete eight weeks of a salsa course in Oxford (of which they need to attend six classes to remain in the study), followed by a one-month follow-up time point.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Participants will wait twelve weeks, completing the questionnaires and tasks at the same study time points as participants in the experimental condition.They will then be offered the opportunity to complete the eight-week salsa course. Should they choose to participate in the salsa course, they will additionally be offered the opportunity to complete questionnaires at two additional time points.
Intervention Type
Behavioral
Intervention Name(s)
Salsa Dancing
Intervention Description
Participants will complete salsa dancing classes in central Oxford with instructor(s) from the Oxford University Salsa Society
Primary Outcome Measure Information:
Title
Change in depressive symptoms from baseline at week four, eight, and twelve
Description
Patient Health Questionnaire (PHQ-9) score. Higher scores indicate greater depressive symptoms.
Time Frame
Will be assessed at week 0, 4, 8, and 12 of the intervention
Secondary Outcome Measure Information:
Title
Change in anxiety symptoms from baseline at week four, eight, and twelve
Description
Generalized Anxiety Disorder Scale (GAD-7) score. Higher scores indicate greater anxiety.
Time Frame
Will be assessed at week 0, 4, 8, and 12 of the intervention
Title
Change in social anxiety symptoms from baseline at week four, eight, and twelve
Description
Social Anxiety Scale - Adolescent (SAS-A) score. Higher scores indicate greater social anxiety.
Time Frame
Will be assessed at week 0, 4, 8, and 12 of the intervention
Title
Change in loneliness from baseline at week four, eight, and twelve
Description
UCLA Loneliness Scale (+ Loneliness Question) score. Higher scores indicate more loneliness.
Time Frame
Will be assessed at week 0, 4, 8, and 12 of the intervention
Title
Change in daily mood questionnaire scores
Description
Scoring one Likert scale mood questionnaire ("How happy do you feel?"), range 1-10. Higher values represent more happiness.
Time Frame
daily from baseline through week 12 of the intervention
Title
Change in social anhedonia from baseline at week four, eight, and twelve
Description
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) score. Higher scores indicate lower social anhedonia.
Time Frame
Will be assessed at week 0, 4, 8, and 12 of the intervention
Title
Change in recognition of positive and negative facial expressions from baseline at week 8
Description
Hit rate for detecting positive versus negative faces in a facial expression recognition task (FERT)
Time Frame
Will be assessed at week 0 and week 8 of the intervention
Title
Change in speed during recognition of positive and negative facial expressions
Description
Reaction times for correctly recognised positive versus negative faces in facial expression recognition task (FERT)
Time Frame
Will be assessed at week 0 and week 8 of the intervention
Title
Change in emotional categorisation (ECAT)
Description
Reaction times for correctly classifying positive versus negative personality characteristic words
Time Frame
Will be assessed at week 0 and week 8 of the intervention
Title
Change in recall in the emotional recall task (EREC)
Description
Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
Time Frame
Will be assessed at week 0 and week 8 of the intervention
Title
Change in memory in the emotional memory task (EMEM)
Description
Number of positive and negative words correctly (and incorrectly) recalled as familiar and novel
Time Frame
Will be assessed at week 0 and week 8 of the intervention
Title
Change in trust behavior in the trust game (Trust Game)
Description
Investment behavior and sensitivity to trustee's generosity when playing the role of the investor in a trust game
Time Frame
Will be assessed at week 0 and week 8 of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals aged 18 to 24 at time of eligibility screening; Competency to give informed consent; Individuals will *not* be excluded for a formal diagnosis of depression from a GP or other mental healthcare provider, nor for being presently or formerly on medication for depression; nor for presently or formerly attending talk therapies; Individuals who do not meet the exclusion criteria specified below. Exclusion Criteria: Individuals with a PHQ-9 score of less than 5 (indicating no low mood) or greater than 19 (indicating a low mood that could be too severe for this research); individuals who self-report a current or recent diagnosis of any psychotic disorder (e.g., bipolar, schizophrenia, schizoaffective disorder), substance use disorders, eating disorders, or personality disorders individuals who self-report that they are unfit for light physical exertion; individuals who regularly, or have regularly, attended partner dance classes or partner dance events within the last six months (as they would already be receiving the potential benefits we are investigating in this study); and individuals for whom the Principal Investigator determines that the study is not suitable.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susannah Murphy, DPhil
Phone
+44 (0)1865 618313
Email
susannah.murphy@psych.ox.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Harmer, DPhil
Email
catherine.harmer@psych.ox.ac.uk
Facility Information:
Facility Name
University of Oxford
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susannah Murphy, DPhil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Oxford Social Movement Activation Study

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