Emotional DistressNCT04837521
Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility
A study testing Unified Protocol in people with Emotional Distress and Anxiety, run by Duke University at 1 site in United States.
Trial summary
Research suggests older adults report wide-ranging emotional distress (e.g., symptoms of anxiety, depression) that negatively impacts their physical and mental health and is associated with a reduction in daily activity. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Emotional Distress, Anxiety, Depression
- What is being tested?
- Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- are age 65+
- report moderate or higher emotional distress
- report reduced engagement in daily activities
- are willing to engage in telehealth.
Who cannot join
- present with conditions requiring immediate prioritization (e.g., suicide attempt within past 6months, suicidal ideation with intent/plan, diagnosed with mania/bipolar I, psychosis)
- are currently receiving psychotherapy
- have been diagnosed with dementia or has significant concerns with memory as per online/phone screener
- have changed their psychiatric medications in the past six weeks
- cannot read
- are blind
- cannot speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Adapting the Unified Protocol to Facilitate Activity in Older Adults
Research suggests older adults report wide-ranging emotional distress (e.g., symptoms of anxiety, depression) that negatively impacts their physical and mental health and is associated with a reduction in daily activity. The overarching goal of this proposal is to adapt an existing evidence-based intervention, the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), to increase activity in older adults by reducing emotional distress. The primary aim of the proposed study is to adapt a 5-session version of the UP for use with older adults reporting emotional distress and reduced engagement in daily activities and to develop a self-guided version of this intervention.
This aim will be accomplished in two phases. In Phase 1, patients will receive a short 5-session version of the UP via telehealth. At the end of treatment, they will provide feedback on the treatment, including any suggested changes, as well as suggestions for changing the treatment that might allow an individual to successfully complete it on their own. This information will be used to iteratively change the treatment and develop a self-guided version of the treatment.
In Phase 2, the study team will compare the therapist-delivered and self-guided versions of treatment to see if patients find them acceptable. In this phase, patients will be randomized to receive one of these two treatments.
Read the detailed description
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an optimal intervention to adapt for older adults to increase their engagement in daily activities. The UP is a type of cognitive behavioral therapy (CBT) with evidence base to reduce psychopathology, especially in transdiagnostic anxiety. As a transdiagnostic treatment, it can be applied across diagnostic categories to address a wide range of presenting problems. The UP is efficacious for anxiety, depression, and related emotional problems and has been used with older adults. The UP contains five core skills that are relevant to increasing activity engagement: Session 1 (Motivation \& Psychoeducation about Emotions); Session 2 (Breaking down Emotions \& Mindfulness); Session 3 (Cognitive Flexibility); Session 4 (Countering Emotion-Driven Behaviors); Session 5 (Exposure and Relapse Prevention).
Transdiagnostic treatments, like the UP, are advantageous for dissemination and implementation because they are adaptable and reduce clinician training burden. The UP has demonstrated adaptability for underserved patient populations and has been successfully abbreviated to meet the needs of unique patient populations. Further, it has been successfully delivered by clinicians without previous CBT experience, increasing its potential for dissemination. A five-session version of this treatment (UP-5) was developed that includes the core skills and showed acceptability in adults with acute suicide risk. The primary aim of this study is to adapt the UP-5 for use with older adults reporting emotional distress to increase their daily activity. Because research indicates the proportion of older adults who access and receive evidence-based treatments is low, the study team is proposing to develop therapist-delivered and self-guided versions of the treatment. Self-guided interventions may be ideal for older adults because they do not compete with other healthcare demands and they have the potential for significant public health impact for older adults where access to services is low. The secondary aim of this study is to compare the self-guided and therapist-delivered versions to begin identifying the minimum level of intervention needed to increase activity in older adults. This project is significant because it will produce an implementable, evidence-based treatment to increase access to evidence-based interventions designed to increase daily activity in older adults.
Phase 1. The purpose of Phase 1 was to adapt self-guided and therapist-delivered versions of the UP from the existing UP-5 using stakeholder feedback. The study used a successive cohort design and delivered the UP-5 to two cohorts of two patients (total of 4). One week after the fifth session, patients provided feedback about the treatment in exit interviews, which was used to develop and refine a self-guided version of the UP-5.
Phase 2. Phase 2 was a pilot randomized controlled trial comparing the adapted self-guided and therapist-delivered versions of the UP-5. Patients were randomized to complete one of these two treatments, 8 patients in each treatment arm. Therapist-delivered treatment was provided by telehealth via the study interventionist. All sessions were audio or video recorded so that a percentage could be rated for therapist adherence. Participants were provided with a pedometer to keep track of their step count throughout treatment. During each therapist-delivered treatment session, starting at session 2, the interventionist completed a Clinical Global Impressions-Improvement (CGI-I) rating and documented how much of the homework they thought the participant completed since the last session (0-100%). Outcomes were evaluated pre/post treatment and include measures of daily activity (PSFS), depression (PROMIS-depression), anxiety (PROMIS-anxiety), cognitive flexibility, experiential avoidance (BEAQ), and mindfulness (SMQ). Treatment satisfaction (Client-Satisfaction Questionnaire) and credibility and expectancy of improvement (CEIS) were evaluated post-treatment. The post-treatment visit was 1 week after completing self-guided or therapist-driven treatment. Five weeks after completing the final treatment session, measures and reporting of daily step count were collected remotely, one final time.
- Conditions
- Emotional Distress, Anxiety, Depression
- Being tested
- Unified Protocol
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
Five session psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Therapist Delivered Unified Protocol | Experimental | This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Receives: Behavioral: Unified Protocol |
| Self-Guided Unified Protocol | Experimental | This is a five session treatment that patients can complete independently. Receives: Behavioral: Unified Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire (CSQ)
The CSQ is measured on a scale of 8-32, with higher scores indicating higher levels of treatment satisfaction
Measured: 1 week (post treatment), 1 month (post treatment)
Change in Patient Specific Functional Scale (PSFS)
The PSFS is a measure that can be used to quantify activity limitation and adapted to particular individuals and their functional status. Participants can include up to five activities, of which they rate their limitations on a 0-10 scale, where 0 corresponds to unable to perform and 10 corresponds to able to perform at the activity as well as usual. This scale is not specifically designed for between-subjects comparisons of specific activities, but has been validated and shown to be sensitive to changes in musculoskeletal conditions within subjects. The scores represent changes from baseline at the reported follow-up periods
Measured: 1 week (post treatment), 1 month (post treatment)
Retention of Participants
Retention of participants through completion of the study
Measured: 1 Month Post Treatment
Secondary outcomes (10)
Change in PROMIS-depression
The PROMIS-depression is measured on a scale of 8-40, with higher scores indicating higher levels of depression. The scores represent changes from baseline at the reported follow up periods.
Measured: 1 week (post treatment), 1 month (post treatment)
Change in PROMIS-anxiety
The PROMIS-anxiety is measured on a scale of 7-35, with higher scores indicating higher levels of anxiety. The scores represent changes from baseline at the reported follow up periods.
Measured: 1 week (post treatment), 1 month (post treatment)
Brief Experiential Avoidance Questionnaire (BEAQ).
The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item self-report measure that assesses an individual's tendency to avoid or escape from unwanted internal experiences, such as uncomfortable emotions, thoughts, memories, or sensations. Higher scores represent more avoidance (range 15- 90). The scores reported here represent changes from baseline at the reported follow up periods.
Measured: 1 week (post treatment), 1 month (post treatment)
Cognitive Flexibility Scale (CFS)
The Cognitive Flexibility Scale (CFS) measures one's ability to adapt in response to changes in environments and situations, on a range from 1 to 72. Higher scores on the CFS indicate greater cognitive flexibility. The scores represent changes from baseline at the reported follow-up periods. Therefore, a positive score represents an increase in cognitive flexibility from baseline.
Measured: 1 week (post treatment), 1 month (post treatment)
Southampton Mindfulness Questionnaire (SMQ)
The SMQ ranges from 0 to 96, with higher scores indicating more mindfulness. The scores represent changes from baseline at the reported follow-up periods.
Measured: 1 week (post treatment), 1 month (post treatment)
PROMIS Physical Function Score
The PROMIS Physical Function Scale is an 8-item self-report examining difficulty with engaging in daily activities. Items are rated on a scale of 1-5 (unable to do -- can do without any difficulty), with lower scores representing more impairment in functioning. The scale ranges from 8 to 40. Here we present changes from baseline.
Measured: 1 week (post treatment), 1 month (post treatment)
Gait Speed
The Short Physical Performance Battery (SPPB) is a performance-based assessment designed to evaluate lower extremity function in older adults(Guralnik et al., 1994). The SPPB includes three components, but in this study, we utilized only the gait speed subtest. Performance was measured by a study team member through a virtual session at some point before the first treatment session and once again at the 1-week follow-up visit. Participants were mailed necessary materials, including measuring tape and black tape, to demarcate a length of three meters. Participants were instructed to walk this distance at their ordinary pace while the time was recorded to calculate their gait speed. Mean gait speed across two trials was calculated at each assessment.
Measured: Baseline (1 week before treatment), 1 week post treatment
Weekly Steps
average for each condition of total weekly steps taken by study participants measured on a pedometer
Measured: at baseline (i.e., the week before session 1 of treatment), during each of the four remaining therapy weeks (session 1--> session 2; 2--> 3; 3-->4; 4--> 5), the week following treatment, the week following a month after treatment ended.
Credibility and Expectancy Score
The CEQ (Devilly \& Borkovec, 2000) is a six-item scale intended to measure patients' perceptions of a treatment's logicality and potential success with good evidence for validity and reliability. At intake, we administered a 6-item adaptation, assessing how logical the UP protocol sounded before being administered and expectations about how effective the treatment would be in reducing distress. We then administered a 5-item adapted version of this questionnaire at one-week and one-month follow-up visits. Participants rated each item on a scale from 1 to 9 ("not at all" - "very"). Items included how logical they perceived the treatment to be, how confident they were in successfully using the strategies presented and recommending it to a friend, and how successful they thought the treatment was at improving emotional well-being and activity levels. A summary score is computed by averaging the answers, with higher scores indicating more credibility of the intervention (range 1-9).
Measured: one week after treatment, one month after treatment
Percent of Adherent Sessions Completed in the Therapist Delivered Arm of the Study.
A rater trained by the PI scored 35% of therapist-driven sessions. Each session was rated using yes/no answers for 12 different domains . An overall computed score captured how many domains were coded as yes in the particular session. The session duration needed to be at least 30 minutes for the session to be considered adherent. In addition, each session was rated for adequacy using 5 items that assessed the therapist's level of engagement and ability to manage the session on a 0-5 scale("Poor" to "Excellent"). These items were averaged. We computed a binary yes/no score that captured whether the session adhered to the protocol. To be adherent, a session needed to include at least 10/12 elements and have an average adequacy rating of at least 3/5. Adherence was not measured in the self-help group because the therapist did not deliver any direct intervention in this group. We present the percentage of sessions coded as adherent from a random selection of videotaped sessions.
Measured: End of the 5 week-treatment for all participants, approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start25 Apr 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Model description
- Phase 1 is Single Group. However, Phase 2 is a parallel comparison of self-guided with therapist-delivered versions of the UP-5
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Andrada Neacsiu, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837521
- Sponsor's protocol ID
- Pro00108029
- Other IDs
- 5P30AG064201-03, DBSR-11068
- Status last verified
- May 2024
- First submitted
- 6 Apr 2021
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available on request and in compliance with IRB regulations.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the Unified Protocol to Facilitate Activity in Older Adults
- ClinicalTrials.gov ID
- NCT04837521
- Acronym / sponsor ID
- Pro00108029
- Conditions
- Emotional Distress, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Posted 10 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research suggests older adults report wide-ranging emotional distress (e.g., symptoms of anxiety, depression) that negatively impacts their physical and mental health and is associated with a reduction in daily activity. The overarching goal of this proposal is to adapt an existing evidence-based intervention, the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), to increase activity in older adults by reducing emotional distress. The primary aim of the proposed study is to adapt a 5-session version of the UP for use with older adults reporting emotional distress and reduced engagement in daily activities and to develop a self-guided version of this intervention.
This aim will be accomplished in two phases. In Phase 1, patients will receive a short 5-session version of the UP via telehealth. At the end of treatment, they will provide feedback on the treatment, including any suggested changes, as well as suggestions for changing the treatment that might allow an individual to successfully complete it on their own. This information will be used to iteratively change the treatment and develop a self-guided version of the treatment.
In Phase 2, the study team will compare the therapist-delivered and self-guided versions of treatment to see if patients find them acceptable. In this phase, patients will be randomized to receive one of these two treatments.
Detailed description
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an optimal intervention to adapt for older adults to increase their engagement in daily activities. The UP is a type of cognitive behavioral therapy (CBT) with evidence base to reduce psychopathology, especially in transdiagnostic anxiety. As a transdiagnostic treatment, it can be applied across diagnostic categories to address a wide range of presenting problems. The UP is efficacious for anxiety, depression, and related emotional problems and has been used with older adults. The UP contains five core skills that are relevant to increasing activity engagement: Session 1 (Motivation \& Psychoeducation about Emotions); Session 2 (Breaking down Emotions \& Mindfulness); Session 3 (Cognitive Flexibility); Session 4 (Countering Emotion-Driven Behaviors); Session 5 (Exposure and Relapse Prevention).
Transdiagnostic treatments, like the UP, are advantageous for dissemination and implementation because they are adaptable and reduce clinician training burden. The UP has demonstrated adaptability for underserved patient populations and has been successfully abbreviated to meet the needs of unique patient populations. Further, it has been successfully delivered by clinicians without previous CBT experience, increasing its potential for dissemination. A five-session version of this treatment (UP-5) was developed that includes the core skills and showed acceptability in adults with acute suicide risk. The primary aim of this study is to adapt the UP-5 for use with older adults reporting emotional distress to increase their daily activity. Because research indicates the proportion of older adults who access and receive evidence-based treatments is low, the study team is proposing to develop therapist-delivered and self-guided versions of the treatment. Self-guided interventions may be ideal for older adults because they do not compete with other healthcare demands and they have the potential for significant public health impact for older adults where access to services is low. The secondary aim of this study is to compare the self-guided and therapist-delivered versions to begin identifying the minimum level of intervention needed to increase activity in older adults. This project is significant because it will produce an implementable, evidence-based treatment to increase access to evidence-based interventions designed to increase daily activity in older adults.
Phase 1. The purpose of Phase 1 was to adapt self-guided and therapist-delivered versions of the UP from the existing UP-5 using stakeholder feedback. The study used a successive cohort design and delivered the UP-5 to two cohorts of two patients (total of 4). One week after the fifth session, patients provided feedback about the treatment in exit interviews, which was used to develop and refine a self-guided version of the UP-5.
Phase 2. Phase 2 was a pilot randomized controlled trial comparing the adapted self-guided and therapist-delivered versions of the UP-5. Patients were randomized to complete one of these two treatments, 8 patients in each treatment arm. Therapist-delivered treatment was provided by telehealth via the study interventionist. All sessions were audio or video recorded so that a percentage could be rated for therapist adherence. Participants were provided with a pedometer to keep track of their step count throughout treatment. During each therapist-delivered treatment session, starting at session 2, the interventionist completed a Clinical Global Impressions-Improvement (CGI-I) rating and documented how much of the homework they thought the participant completed since the last session (0-100%). Outcomes were evaluated pre/post treatment and include measures of daily activity (PSFS), depression (PROMIS-depression), anxiety (PROMIS-anxiety), cognitive flexibility, experiential avoidance (BEAQ), and mindfulness (SMQ). Treatment satisfaction (Client-Satisfaction Questionnaire) and credibility and expectancy of improvement (CEIS) were evaluated post-treatment. The post-treatment visit was 1 week after completing self-guided or therapist-driven treatment. Five weeks after completing the final treatment session, measures and reporting of daily step count were collected remotely, one final time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 is Single Group. However, Phase 2 is a parallel comparison of self-guided with therapist-delivered versions of the UP-5
| Arm | Type | Receives |
|---|---|---|
| Therapist Delivered Unified Protocol | Experimental | Behavioral: Unified ProtocolThis is a five session psychotherapy designed to help people with problems such as anxiety and depression. |
| Self-Guided Unified Protocol | Experimental | Behavioral: Unified ProtocolThis is a five session treatment that patients can complete independently. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- are age 65+
- report moderate or higher emotional distress
- report reduced engagement in daily activities
- are willing to engage in telehealth.
Key exclusion criteria (7 listed)
- present with conditions requiring immediate prioritization (e.g., suicide attempt within past 6months, suicidal ideation with intent/plan, diagnosed with mania/bipolar I, psychosis)
- are currently receiving psychotherapy
- have been diagnosed with dementia or has significant concerns with memory as per online/phone screener
- have changed their psychiatric medications in the past six weeks
- cannot read
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 |
|---|---|---|
| Unified ProtocolFive session psychotherapy | Behavioural | Self-Guided Unified Protocol, Therapist Delivered Unified Protocol |
Primary outcome
Client Satisfaction Questionnaire (CSQ)
Time frame: 1 week (post treatment), 1 month (post treatment)
The CSQ is measured on a scale of 8-32, with higher scores indicating higher levels of treatment satisfaction
Change in Patient Specific Functional Scale (PSFS)
Time frame: 1 week (post treatment), 1 month (post treatment)
The PSFS is a measure that can be used to quantify activity limitation and adapted to particular individuals and their functional status. Participants can include up to five activities, of which they rate their limitations on a 0-10 scale, where 0 corresponds to unable to perform and 10 corresponds to able to perform at the activity as well as usual. This scale is not specifically designed for between-subjects comparisons of specific activities, but has been validated and shown to be sensitive to changes in musculoskeletal conditions within subjects. The scores represent changes from baseline at the reported follow-up periods
Retention of Participants
Time frame: 1 Month Post Treatment
Retention of participants through completion of the study
10 secondary outcomes
Change in PROMIS-depression
Time frame: 1 week (post treatment), 1 month (post treatment)
Change in PROMIS-anxiety
Time frame: 1 week (post treatment), 1 month (post treatment)
Brief Experiential Avoidance Questionnaire (BEAQ).
Time frame: 1 week (post treatment), 1 month (post treatment)
Cognitive Flexibility Scale (CFS)
Time frame: 1 week (post treatment), 1 month (post treatment)
Southampton Mindfulness Questionnaire (SMQ)
Time frame: 1 week (post treatment), 1 month (post treatment)
PROMIS Physical Function Score
Time frame: 1 week (post treatment), 1 month (post treatment)
Gait Speed
Time frame: Baseline (1 week before treatment), 1 week post treatment
Weekly Steps
Time frame: at baseline (i.e., the week before session 1 of treatment), during each of the four remaining therapy weeks (session 1--> session 2; 2--> 3; 3-->4; 4--> 5), the week following treatment, the week following a month after treatment ended.
Credibility and Expectancy Score
Time frame: one week after treatment, one month after treatment
Percent of Adherent Sessions Completed in the Therapist Delivered Arm of the Study.
Time frame: End of the 5 week-treatment for all participants, approximately 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will be available on request and in compliance with IRB regulations.
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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.
Andrada Neacsiu, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol in people with Emotional Distress and Anxiety, run by Duke 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 1 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Client Satisfaction Questionnaire (CSQ) (time frame: 1 week (post treatment), 1 month (post treatment)). 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 1 Jul 2025.