Chronic PainNCT07791355
Pain Reprocessing Therapy (PRT) in a Specialist Pain Clinic: A Feasibility Study
A study testing Pain Reprocessing Therapy in people with Chronic Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Long-term pain, which is pain that lasts for more than three months, is a major health problem. It can severely impact a person's physical and mental well-being, quality of life, and ability to work. It also carries high costs for society, mainly due to high rates of sick leave. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain Reprocessing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older.
- Completed medical investigation regarding the pain diagnosis. Primary pain conditions (according to ICD-11) or nociplastic pain, as well as mixed conditions where patients have nociplastic pain combined with nociceptive and/or neuropathic pain (e.g., fibromyalgia, chronic widespread pain, primary chronic back pain).
- Pain duration of at least 3 months.
- Current medication regimen compatible with participating in and benefiting from highly specialized rehabilitation.
- Ability to read, speak, and understand the Swedish language.
Who cannot join
- Severe psychiatric conditions (e.g., psychosis, severe depression, and suicidality).
- Current substance abuse (including overuse of prescription medications) or dementia.
- Cancer pain, cauda equina syndrome, or other medical conditions that constitute the primary explanation for the patient's pain.
- Another psychological treatment for pain within the past 3 months.
- Ongoing parallel treatments related to the patient's pain at other clinics, with the exception of ongoing pharmacological treatment.
- Ongoing legal disputes or active claims for disability compensation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm
Andreas Hellerström, +46704535889, andreas.hellerstrom@ki.se
About this study
Official title: Breaking the Pain Cycle: Implementing a Novel Neuroscience-based Behavioral Therapy for Chronic Pain in a Pain Rehabilitation Setting
Long-term pain, which is pain that lasts for more than three months, is a major health problem. It can severely impact a person's physical and mental well-being, quality of life, and ability to work. It also carries high costs for society, mainly due to high rates of sick leave.
For many people with long-term pain, there is no clear injury or disease that fully explains why it hurts. In these cases, the pain is believed to be caused by how the brain and nervous system process pain signals. This is sometimes called "nociplastic pain."
Read more
Even though there are many treatments for pain-like medications and therapies-they don't work for everyone, and many people are left without meaningful relief. Because of this, it is important to find and test new ways to treat pain. In this study, the investigators evaluate a relatively new psychological treatment called Pain Reprocessing Therapy (PRT), which has been tested in the US with promising results.
PRT helps individuals with chronic pain to understand and change how they think about their pain by explaining how the brain works. The treatment focuses on teaching the difference between acute (new) pain and long-term pain. It also involves exercises to help people alter emotions related to their pain. A key part of the treatment is a technique where patients practice paying attention to what is happening in their bodies in a safe, relaxed way. The goal is to teach the brain that the pain signals are not a threat. This can help break the vicious cycle of fear, avoiding activities, and worsening pain.
While many people are interested in treatments like PRT, it hasn't yet been tested in specialized care for patients with complex pain. This trial is a pilot study-a smaller, initial investigation to evaluate how well the treatment works in a clinical setting, and to determine if both patients and therapists find it acceptable and practical to use. This will give us important information to help prepare for larger studies in the future.
The main goal of this pilot study is to see if PRT is a practical and accepted treatment in a Swedish pain rehabilitation setting. The investigators also want to look at whether the treatment helps reduce pain, psychological distress, negative thoughts about pain, and the fear of moving. Finally, the investigators will explore how a patient's expectations and thinking skills (such as memory and focus) might affect how well the treatment works, and take physical measurements before and after the treatment to see if the nervous system becomes better at regulating pain.
Read the detailed description
The overall aim of this project is to conduct a pilot study investigating the feasibility, patient satisfaction, and acceptability of a recently developed psychological treatment for pain: Pain Reprocessing Therapy (PRT). The study will be conducted within a clinical pain rehabilitation setting, where patients frequently present with severe pain, psychiatric comorbidity, and reduced or absent work capacity.
Within the framework of this project, the investigators will evaluate whether PRT can be effectively implemented in a pain rehabilitation context and whether the treatment is perceived as acceptable and feasible by both patients and clinicians. Furthermore, the investigators intend to conduct exploratory analyses to determine if specific clinical subgroups appear more responsive to the intervention.
A secondary aim is to evaluate changes in pain intensity, functional capacity, fear of movement (kinesiophobia), pain catastrophizing, as well as symptoms of anxiety and depression. Although study participants will not be randomized, the results will be compared to a matched reference group drawn from the Swedish Quality Registry for Pain Rehabilitation (SQRP). This reference group, comprising individuals who have undergone standard multimodal pain rehabilitation, is included to provide a contextualizing indication of whether PRT is associated with clinically relevant changes in the outcome measures.
The project is designed as a single-arm pilot study in which all participants will receive PRT. Data collection will occur at baseline, during the intervention, and post-treatment. PRT, which has previously been evaluated primarily in a selected population with chronic back pain and limited comorbidity, aims to modify the patient's interpretation of the cause of their pain and its perceived threat value. By targeting fear-avoidance responses triggered by somatic signals, the ultimate objective of the treatment is to facilitate sustained symptom relief.
Primary Objective:
The primary objective is to investigate whether a 9-week treatment with Pain Reprocessing Therapy (PRT) meets predefined criteria for feasibility and acceptability.
Primary Research Questions:
- Is an adequate recruitment rate achieved among approached patients?
- Does a sufficiently large proportion of the included participants complete the treatment program (retention rate)?
- Does the treatment demonstrate adequate patient satisfaction?
- Are patient attendance and treatment adherence, in terms of completing homework assignments, consistent with predefined benchmarks?
- Do the clinicians demonstrate adequate treatment fidelity to the PRT manual?
Secondary Objective:
The secondary objective is to exploratively investigate whether PRT is associated with changes in predefined clinical outcome measures.
Secondary Research Questions:
- Are there observed changes in self-rated pain experience, quality of life, symptoms of anxiety and depression, fear of movement (kinesiophobia), pain-related catastrophizing, fatigue and sickness behavior?
- How do changes in outcome measures following PRT compare to a matched reference group that has undergone standard multimodal pain rehabilitation?
Exploratory Research Questions:
- Are participants' initial treatment expectations and perceived credibility , as well as their perception of clinician empathy, cognitive functioning and pain sensitivity associated with treatment outcomes?
- How are cognitive function and pain sensitivity affected by the treatment?
- How do participants describe their experiences of the treatment and perceived processes of change in qualitative interviews?
- Conditions
- Chronic Pain
- Being tested
- Pain Reprocessing Therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Reprocessing TherapyBehavioural
A 9-week intervention with 9 individual sessions and 3 group sessions based on Pain Reprocessing Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Pain Reprocessing Therapy | Experimental | Not described Receives: Behavioral: Pain Reprocessing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
The retention rate is defined as the percentage of participants who successfully complete the PRT intervention. To be considered a completer, a participant must attend at least 6 of the 9 individual sessions and complete all post-treatment outcome measures. The benchmark for study feasibility is set at 75%
Measured: From enrollment to 9 weeks (post treatment).
Recruitment rate
Feasibility of recruitment, defined as percentage of eligible participants who give informed consent and are enrolled in the study. The predefined benchmark for feasibility of recruitment rate is set as at least 70%
Measured: From study start to recruitment completion, an estimated 6 months
Patient treatment satisfaction
Assessed using the Client Satisfaction Questionnaire (CSQ-8). The total score ranges from 8 to 32. Higher scores indicate greater satisfaction with the treatment received, representing a better outcome. The predefined benchmark for acceptability is set to a mean total score of 24 or higher (out of a maximum of 32).
Measured: Post treatment (9 weeks)
Adherence to treatment
Adherence to the in-between session work with home assignments, as logged by the therapists during the 9-week program. The predefined benchmark for adequate adherence is at least 70% of assigned homework tasks.
Measured: From enrollment to the end of the treatment at 9 weeks
Therapists treatment fidelity
The degree to which the therapists adhere to the core interventions of the treatment. Evaluated by therapist self-report using a study-specific PRT fidelity checklist completed after each session. The predefined benchmark for adequate treatment fidelity is set to an average adherence score of at least 80%.
Measured: From treatment start to the end of treatment at 9 weeks
Secondary outcomes (10)
Pain Catastrophizing Scale (PCS)
The PCS assesses negative thoughts and emotions associated with past, present or anticipated pain. The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.
Measured: Baseline and week 9
Tampa Scale of Kinesiophobia (TSK)
The TSK assesses fear of movement or re-injury. The 17-item version is used. Total scores range from 17 to 68. Higher scores indicates a higher degree of kinesiophobia.
Measured: Baseline and week 9
Hospital Anxiety and Depression Scale (HADS)
The HADS scale measures anxiety and depression symptoms. The HADS contains of 14 items, divided into 2 subscales (anxiety and depression). For each subscale, the total score ranges from 0 to 21. Higher scores indicate greater severity of anxiety and depression symptoms.
Measured: Baseline and week 9
EQ-5D
The EQ-5D measures health-related quality of life across five dimensions. Responses are converted into a single index score. The index score typically ranges from a minimum of less than 0 (often around -0.59, representing a health state worse than death) to a maximum of 1.0 (representing full health). Higher index scores indicate a better health-related quality of life.
Measured: Baseline and week 9 (post treatment)
EQ-5D VAS
Measures self-rated overall health using a Visual Analogue Scale (EQ-VAS). Participants rate their overall health using a vertical visual analogue scale rangeing from 0-100. Higher scores indicates a better self-percieved health.
Measured: Baseline to 9 week (post treatment)
Sickness Questionnaire (SicknessQ)
The SicknessQ assesses self-reported sickness behavior (e.g., fatigue, social withdrawal. The scores ranges from 0 tp 30. Higher scores indicate a higher degree of sickness behavior.
Measured: Baseline and week 9.
Multidimensional Fatigue Inventory (MFI-20)
The MFI-20 assesses five dimensions of fatigue. The total score ranges from 20-100 where higher scores indicate higher levels of fatigue.
Measured: Baseline to 9-week (post treatment)
Numeric Rating Scale For Pain
The NRS measures pain intensity where participants rate their pain intensity during the past week on an 11 point scale from 0 to 10. Higher scores indicate worse pain intensity.
Measured: Baseline and week 9 (Post treatment)
Consultation and Relational Empathy Measure (CARE)
The CARE-scale assesses the participants perception of the therapists empathy during sessions. The maximum score is 50. Higher scores indicate greater percieved empathy from the treating clinician
Measured: Week 2 and 9 (post treatment)
Credibility/Expectancy Questionnaire (CEQ)
The CEQ assesses how logical the treatment seems to the patient, and how much improvement they expect. Scores for each subscale range from 3 to 27. Higher scores indicate higher perceived credibility and expectancy of clinical improvement.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- For exploratory purpouses, this pilot study will utilize a matched reference group drawn from the Swedish Quality Registry for Pain Rehabilitation.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Maria Lalouni, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791355
- Sponsor's protocol ID
- 2026-01099-01
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking the Pain Cycle: Implementing a Novel Neuroscience-based Behavioral Therapy for Chronic Pain in a Pain Rehabilitation Setting
- ClinicalTrials.gov ID
- NCT07791355
- Acronym / sponsor ID
- 2026-01099-01
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Aug 2026 (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.
Long-term pain, which is pain that lasts for more than three months, is a major health problem. It can severely impact a person's physical and mental well-being, quality of life, and ability to work. It also carries high costs for society, mainly due to high rates of sick leave.
For many people with long-term pain, there is no clear injury or disease that fully explains why it hurts. In these cases, the pain is believed to be caused by how the brain and nervous system process pain signals. This is sometimes called "nociplastic pain."
Even though there are many treatments for pain-like medications and therapies-they don't work for everyone, and many people are left without meaningful relief. Because of this, it is important to find and test new ways to treat pain. In this study, the investigators evaluate a relatively new psychological treatment called Pain Reprocessing Therapy (PRT), which has been tested in the US with promising results.
PRT helps individuals with chronic pain to understand and change how they think about their pain by explaining how the brain works. The treatment focuses on teaching the difference between acute (new) pain and long-term pain. It also involves exercises to help people alter emotions related to their pain. A key part of the treatment is a technique where patients practice paying attention to what is happening in their bodies in a safe, relaxed way. The goal is to teach the brain that the pain signals are not a threat. This can help break the vicious cycle of fear, avoiding activities, and worsening pain.
While many people are interested in treatments like PRT, it hasn't yet been tested in specialized care for patients with complex pain. This trial is a pilot study-a smaller, initial investigation to evaluate how well the treatment works in a clinical setting, and to determine if both patients and therapists find it acceptable and practical to use. This will give us important information to help prepare for larger studies in the future.
The main goal of this pilot study is to see if PRT is a practical and accepted treatment in a Swedish pain rehabilitation setting. The investigators also want to look at whether the treatment helps reduce pain, psychological distress, negative thoughts about pain, and the fear of moving. Finally, the investigators will explore how a patient's expectations and thinking skills (such as memory and focus) might affect how well the treatment works, and take physical measurements before and after the treatment to see if the nervous system becomes better at regulating pain.
Detailed description
The overall aim of this project is to conduct a pilot study investigating the feasibility, patient satisfaction, and acceptability of a recently developed psychological treatment for pain: Pain Reprocessing Therapy (PRT). The study will be conducted within a clinical pain rehabilitation setting, where patients frequently present with severe pain, psychiatric comorbidity, and reduced or absent work capacity.
Within the framework of this project, the investigators will evaluate whether PRT can be effectively implemented in a pain rehabilitation context and whether the treatment is perceived as acceptable and feasible by both patients and clinicians. Furthermore, the investigators intend to conduct exploratory analyses to determine if specific clinical subgroups appear more responsive to the intervention.
A secondary aim is to evaluate changes in pain intensity, functional capacity, fear of movement (kinesiophobia), pain catastrophizing, as well as symptoms of anxiety and depression. Although study participants will not be randomized, the results will be compared to a matched reference group drawn from the Swedish Quality Registry for Pain Rehabilitation (SQRP). This reference group, comprising individuals who have undergone standard multimodal pain rehabilitation, is included to provide a contextualizing indication of whether PRT is associated with clinically relevant changes in the outcome measures.
The project is designed as a single-arm pilot study in which all participants will receive PRT. Data collection will occur at baseline, during the intervention, and post-treatment. PRT, which has previously been evaluated primarily in a selected population with chronic back pain and limited comorbidity, aims to modify the patient's interpretation of the cause of their pain and its perceived threat value. By targeting fear-avoidance responses triggered by somatic signals, the ultimate objective of the treatment is to facilitate sustained symptom relief.
Primary Objective:
The primary objective is to investigate whether a 9-week treatment with Pain Reprocessing Therapy (PRT) meets predefined criteria for feasibility and acceptability.
Primary Research Questions:
- Is an adequate recruitment rate achieved among approached patients?
- Does a sufficiently large proportion of the included participants complete the treatment program (retention rate)?
- Does the treatment demonstrate adequate patient satisfaction?
- Are patient attendance and treatment adherence, in terms of completing homework assignments, consistent with predefined benchmarks?
- Do the clinicians demonstrate adequate treatment fidelity to the PRT manual?
Secondary Objective:
The secondary objective is to exploratively investigate whether PRT is associated with changes in predefined clinical outcome measures.
Secondary Research Questions:
- Are there observed changes in self-rated pain experience, quality of life, symptoms of anxiety and depression, fear of movement (kinesiophobia), pain-related catastrophizing, fatigue and sickness behavior?
- How do changes in outcome measures following PRT compare to a matched reference group that has undergone standard multimodal pain rehabilitation?
Exploratory Research Questions:
- Are participants' initial treatment expectations and perceived credibility , as well as their perception of clinician empathy, cognitive functioning and pain sensitivity associated with treatment outcomes?
- How are cognitive function and pain sensitivity affected by the treatment?
- How do participants describe their experiences of the treatment and perceived processes of change in qualitative interviews?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For exploratory purpouses, this pilot study will utilize a matched reference group drawn from the Swedish Quality Registry for Pain Rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| Pain Reprocessing Therapy | Experimental | Behavioral: Pain Reprocessing Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years and older.
- Completed medical investigation regarding the pain diagnosis. Primary pain conditions (according to ICD-11) or nociplastic pain, as well as mixed conditions where patients have nociplastic pain combined with nociceptive and/or neuropathic pain (e.g., fibromyalgia, chronic widespread pain, primary chronic back pain).
- Pain duration of at least 3 months.
- Current medication regimen compatible with participating in and benefiting from highly specialized rehabilitation.
- Ability to read, speak, and understand the Swedish language.
Key exclusion criteria (6 listed)
- Severe psychiatric conditions (e.g., psychosis, severe depression, and suicidality).
- Current substance abuse (including overuse of prescription medications) or dementia.
- Cancer pain, cauda equina syndrome, or other medical conditions that constitute the primary explanation for the patient's pain.
- Another psychological treatment for pain within the past 3 months.
- Ongoing parallel treatments related to the patient's pain at other clinics, with the exception of ongoing pharmacological treatment.
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 |
|---|---|---|
| Pain Reprocessing TherapyA 9-week intervention with 9 individual sessions and 3 group sessions based on Pain Reprocessing Therapy. | Behavioural | Pain Reprocessing Therapy |
Primary outcome
Retention rate
Time frame: From enrollment to 9 weeks (post treatment).
The retention rate is defined as the percentage of participants who successfully complete the PRT intervention. To be considered a completer, a participant must attend at least 6 of the 9 individual sessions and complete all post-treatment outcome measures. The benchmark for study feasibility is set at 75%
Recruitment rate
Time frame: From study start to recruitment completion, an estimated 6 months
Feasibility of recruitment, defined as percentage of eligible participants who give informed consent and are enrolled in the study. The predefined benchmark for feasibility of recruitment rate is set as at least 70%
Patient treatment satisfaction
Time frame: Post treatment (9 weeks)
Assessed using the Client Satisfaction Questionnaire (CSQ-8). The total score ranges from 8 to 32. Higher scores indicate greater satisfaction with the treatment received, representing a better outcome. The predefined benchmark for acceptability is set to a mean total score of 24 or higher (out of a maximum of 32).
Adherence to treatment
Time frame: From enrollment to the end of the treatment at 9 weeks
Adherence to the in-between session work with home assignments, as logged by the therapists during the 9-week program. The predefined benchmark for adequate adherence is at least 70% of assigned homework tasks.
Therapists treatment fidelity
Time frame: From treatment start to the end of treatment at 9 weeks
The degree to which the therapists adhere to the core interventions of the treatment. Evaluated by therapist self-report using a study-specific PRT fidelity checklist completed after each session. The predefined benchmark for adequate treatment fidelity is set to an average adherence score of at least 80%.
10 secondary outcomes
Pain Catastrophizing Scale (PCS)
Time frame: Baseline and week 9
Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline and week 9
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and week 9
EQ-5D
Time frame: Baseline and week 9 (post treatment)
EQ-5D VAS
Time frame: Baseline to 9 week (post treatment)
Sickness Questionnaire (SicknessQ)
Time frame: Baseline and week 9.
Multidimensional Fatigue Inventory (MFI-20)
Time frame: Baseline to 9-week (post treatment)
Numeric Rating Scale For Pain
Time frame: Baseline and week 9 (Post treatment)
Consultation and Relational Empathy Measure (CARE)
Time frame: Week 2 and 9 (post treatment)
Credibility/Expectancy Questionnaire (CEQ)
Time frame: Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Reprocessing Therapy in people with Chronic Pain, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: From enrollment to 9 weeks (post treatment).). The study lists 5 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 27 Aug 2026.