Psychological DistressNCT02662205
Group Yoga Therapy at a College Counseling Center
A study testing Psychotherapy Group, Yoga class and Yoga Therapy Group in people with Psychological Distress and Mindfulness, run by Jenilee Sneed.
Trial summary
Clients of the student counseling center at Oklahoma State University who are interested in participating in the study will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Outcome of the three conditions will be compared. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Mindfulness
- What is being tested?
- Psychotherapy Group, Yoga class and Yoga Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- 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
- Students at Oklahoma State University
- Appropriate for group therapy
- Physically capable of doing yoga
Who cannot join
- non-students
- inappropriate for group therapy treatment
- physical injuries not appropriate for yoga participation
About this study
Official title: A Controlled Trial of Group Yoga Therapy at a College Counseling Center
Clients of the student counseling center at Oklahoma State University who are interested in participating in the study will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Outcome of the three conditions will be compared.
Read the detailed description
Clients will be screened for appropriateness for group treatment and yoga. They will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Each condition will run concurrently for 8 weeks. Outcome measures will be administered before trial commencement and after the trial ends.
- Conditions
- Psychological Distress, Mindfulness
- Being tested
- Psychotherapy Group, Yoga class, Yoga Therapy Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy GroupOther
Traditional process group
Yoga classOther
Yin yoga class
Yoga Therapy GroupOther
Yoga psychotherapy group integrating yoga and process dialogue
| Study group | Role | What they receive |
|---|---|---|
| Traditional Group | Active comparator | Traditional process psychotherapy group Receives: Other: Psychotherapy Group |
| Yoga Therapy Group | Experimental | Psychotherapy group integrating yoga and process dialogue Receives: Other: Yoga Therapy Group |
| Yoga Class | Active comparator | Yin yoga class Receives: Other: Yoga class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counseling Center Assessment of Psychological Symptoms-62
Change in psychological symptoms from baseline on the Counseling Center Assessment of Psychological Symptoms-62 at 8 weeks is being assessed.
Measured: change from baseline at 8 weeks
Outcome Questionnaire- 45.2
Change in psychological symptoms from baseline on the Outcome Questionnaire- 45.2 at 8 weeks is being assessed.
Measured: change from baseline at 8 weeks
Mindful Attention and Awareness Scale
Change in mindfulness from baseline on the Mindful Attention and Awareness Scale at 8 weeks is being assessed.
Measured: change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: We did not get adequate referrals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenilee Sneed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jenilee Sneed, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662205
- Sponsor's protocol ID
- OKState
- Status last verified
- Mar 2016
- First submitted
- 12 Jan 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Group Yoga Therapy at a College Counseling Center
- ClinicalTrials.gov ID
- NCT02662205
- Acronym / sponsor ID
- OKState
- Conditions
- Psychological Distress, Mindfulness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We did not get adequate referrals.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jenilee SneedUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 25 Jan 2016 (estimated)
- 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.
Clients of the student counseling center at Oklahoma State University who are interested in participating in the study will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Outcome of the three conditions will be compared.
Detailed description
Clients will be screened for appropriateness for group treatment and yoga. They will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Each condition will run concurrently for 8 weeks. Outcome measures will be administered before trial commencement and after the trial ends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Group | Active comparator | Other: Psychotherapy GroupTraditional process psychotherapy group |
| Yoga Therapy Group | Experimental | Other: Yoga Therapy GroupPsychotherapy group integrating yoga and process dialogue |
| Yoga Class | Active comparator | Other: Yoga classYin yoga class |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Students at Oklahoma State University
- Appropriate for group therapy
- Physically capable of doing yoga
Key exclusion criteria (3 listed)
- non-students
- inappropriate for group therapy treatment
- physical injuries not appropriate for yoga participation
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 |
|---|---|---|
| Psychotherapy GroupTraditional process group | Other | Traditional Group |
| Yoga classYin yoga class | Other | Yoga Class |
| Yoga Therapy GroupYoga psychotherapy group integrating yoga and process dialogue | Other | Yoga Therapy Group |
Primary outcome
Counseling Center Assessment of Psychological Symptoms-62
Time frame: change from baseline at 8 weeks
Change in psychological symptoms from baseline on the Counseling Center Assessment of Psychological Symptoms-62 at 8 weeks is being assessed.
Outcome Questionnaire- 45.2
Time frame: change from baseline at 8 weeks
Change in psychological symptoms from baseline on the Outcome Questionnaire- 45.2 at 8 weeks is being assessed.
Mindful Attention and Awareness Scale
Time frame: change from baseline at 8 weeks
Change in mindfulness from baseline on the Mindful Attention and Awareness Scale at 8 weeks is being assessed.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy Group, Yoga class and Yoga Therapy Group in people with Psychological Distress and Mindfulness, run by Jenilee Sneed.
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 3 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: withdrawn, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Counseling Center Assessment of Psychological Symptoms-62 (time frame: change from baseline at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2016.