Suicide PreventionNCT06466356
Psychoeducational Course for Suicide Prevention
A study testing Psychoeducational Course for Suicide Prevention, Individual therapy session and Treatment as usual in people with Suicide Prevention and Suicide Threat, run by St. Olavs Hospital at 2 sites in Norway.
Trial summary
The plan is to include patients with a history of increased risk of suicide. In the aftermath of an episode of imminent suicide risk, patients will receive a psychoeducational course that entails information on different aspects of suicide-related topics, identifying triggers and detecting early warning signals for… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Suicide Prevention, Suicide Threat, Self Efficacy
- What is being tested?
- Psychoeducational Course for Suicide Prevention, Individual therapy session and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesNorway
- Study dates
- 3 Jun 2024to 31 Dec 2031
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a suicide attempt, suicidal behavior, or risk of suicidal behavior and a clinician evaluating that the patient has an intention to die
- Patients with a suicide attempt or suicidal behavior defined as "a self-inflicted, potentially injurious behavior with a non-fatal outcome for which there is evidence of intention of death and/or considered to have had or been close to a suicidal crisis syndrome.
Who cannot join
- Not being sufficiently fluent in Norwegian to provide informed consent, valid responses on psychometric testing or to benefit from a psychoeducative course.
- A known diagnosis of ICD-10 F 60.3 (borderline personality disorder) with similar symptoms at previous admittances.
- Ongoing psychosis.
- A substance abuse condition to such a degree that they are unable to comply with the protocol and are considered to be at risk when attending psychoeducational courses.
- Organic brain disorders or mental disabilities in such a degree that they are unable to comply with the protocol.
- Not being able to give an informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thine Rishaug, MD contact
Norway2 sites, 2 recruiting
- Recruiting
Helse Nord-Trøndelag
Levanger, Trøndelag, 7600
Katrine Kveli K Fjukstad, PhD, +4774098600, katrine.k.fjukstad@ntnu.no
Thine MK Rishaug, MD, +4772573000, Thine.Marita.Kirkeby.Rishaug@stolav.no
- Recruiting
St. Olav Hospital
Trondheim, Trøndelag, 7006
Thine MK Rishaug, MD, +4772573000, Thine.Marita.Kirkeby.Rishaug@stolav.no
Karina S Høyen, PhD, 4772573000, Karina.Sagmo.Hoyen@stolav.no
About this study
Official title: Psychoeducational Course for Suicide Prevention - a Randomized Controlled Trial
The plan is to include patients with a history of increased risk of suicide. In the aftermath of an episode of imminent suicide risk, patients will receive a psychoeducational course that entails information on different aspects of suicide-related topics, identifying triggers and detecting early warning signals for increased suicide risk. The course culminates in working on completing a individual safety plan to prevent an future increase in suicide risk. The course will incorporate both patients and their next of kin. The psychoeducational course will be compared to a control group where the patients receive one individual session with focus on a safety plan to evaluate the intervention. Both groups will receive treatment as usual (TAU) during both the acute phase and follow-up. The study will be conducted as a randomized controlled trial.
Read the detailed description
Patients will be included during admittance in the acute psychiatric ward or when in contact with the outpatient team for acute and emergency psychiatry. They will receive acute treatment and be placed on a waiting list until enough patients are included to start the intervention. Then the included patients will be randomized to either the psychoeducational course or the individual session. The course and the individual lessons start at the same time. Each group includes 8-10 participant to receive a group based psychoeducative intervention (three for patients, one for next of kin) and TAU.
The first session (2x45 min) focus on information on suicidal thoughts, mental pain, suicide attempts and suicide as a phenomenon with focus on vulnerability factors, risk development and development of the suicidal crisis syndrome. The second session (2x45 min) tackles identifying triggers for increase in suicide risk and suicidal impulses, detecting early warning signals for increased suicide risk and how to recognize the change as it happens. In the third session (3x45 min) patients work on completing the individual safety plan to prevent an increase in suicide risk. The plan includes "situations that may trigger increased risk", "how to recognize and communicate the increased risk" and "actions that may reduce or increase risk." Finally, the fourth and last session (2x45 min) is aimed at the next of kin that the group participant wants to attend. Patients do not attend this session. The next of kin receive a review of the information from the first two sessions, as well as focus on what the next of kin can or cannot do to help if the risk of suicide increases.
The control group receive one individual session with focus on suicide risk and safety plan with a psychologist or physician and TAU.
Randomization and masking of study groups Participants will be equally randomized (1:1) in the intervention and control group. Patients will be included during admittance in the acute psychiatric ward or when in contact with the outpatient team for acute and emergency psychiatry. The first randomization takes place when sixteen to twenty participants are included. Randomization will take place by manual randomization by an external person at the Research department at St. Olav Hospital in Trondheim. This ensures an equal distribution between the intervention group and the control group. The patient and treating clinician will be unblinded to treatment modality. To compensate for lack of blinding concerning the received treatment, the persons ratings, subsequent measurements and data collection at follow-up will be blinded to the treatment conditions to avoid confirmation bias. The statistical advisor will also be blinded to treatment modality.
- Conditions
- Suicide Prevention, Suicide Threat, Self Efficacy, Stress, Psychological, Psychiatric Emergency, Psychiatric Disorder
- Being tested
- Psychoeducational Course for Suicide Prevention, Individual therapy session, Treatment as usual
- Keywords
- Psychoeducation, Safety plan, Gatekeeper, Suicidal crisis syndrome
- Medical subject headings
- Suicide Prevention, Stress, Psychological, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational Course for Suicide PreventionOther
Baseline variables includes diagnosis using ICD-10 criteria for research and demographic variables such as age, sex, level of education and occupation. Following assessments will be used when including patients for the project: The General self-efficacy scale (GSE) with additional questions related to the theme of the psychoeducational topics, The mental pain questionnaire (MPQ, Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT) The Patient Health Questionnaire (PHQ-9), GAD-7, The SCS-Checklist and SCI-5. GSE, MPQ and PHQ-9 will be measured after intervention and after 6, 12, 24 and 60 months.
Individual therapy sessionOther
Baseline variables includes diagnosis using ICD-10 criteria for research and demographic variables such as age, sex, level of education and occupation. Following assessments will be used when including patients for the project: The General self-efficacy scale (GSE) with additional questions related to the theme of the psychoeducational topics, The mental pain questionnaire (MPQ, Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT) The Patient Health Questionnaire (PHQ-9), GAD-7, The SCS-Checklist and SCI-5. GSE, MPQ and PHQ-9 will be measured after intervention and after 6, 12, 24 and 60 months.
Treatment as usualOther
Treatment as usual (TAU) may include the use of psychotropic drugs, in and out-patient treatment, occupational therapy and other interventions the patients physician deem necessary.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational group therapy | Experimental | Group therapy session, 3 meetings. Each group includes 8-10 participant to receive a group based psychoeducative intervention (three for patients, one for next of kin) and TAU. Receives: Other: Psychoeducational Course for Suicide Prevention; Other: Treatment as usual |
| Individual therapy session | Active comparator | The participants in the control group receive one individual therapy session with focus on suicide risk and safety plan with a psychologist or physician and TAU Receives: Other: Individual therapy session; Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self efficacy
The General self-efficacy scale (GSE) measures optimistic self-beliefs in coping with the demands, tasks and challenges of life in general. It consists of 10 statements that respondents rate on a scale from 1 (not at all true) to 4 (exactly true). The individual's scores on each item are summed up to a GSE score with higher scores indicating higher GSE. Questions regarding the perceived efficacy regarding handling future episodes of increased suicide is added. An increase of ≥ 5 points on the GSE scale is considered the limit for a minimally clinically important change.
Measured: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
Secondary outcomes (9)
Mental pain
The mental pain questionnaire (MPQ). The MPQ includes statements on sense of emptiness, loss of meaning and suffering. The statements are formulated on a dichotomous response format. Higher scores indicate higher level of mental pain. MPQ is a simple 10-items self-rating questionnaire and is a transdiagnostic tool. Minimum score 0, maximum score 10.
Measured: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
Symptoms of depression
Symptoms measured by Patient Health Questionnaire (PHQ-9). The nine-item PHQ-9 is a depressive symptom scale. Scores range from minimum 0 to maximum 27. Higher scores indicate a worse outcome
Measured: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
Symptoms of anxiety
The Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity of anxiety. Scores range from minimum 0 to maximum 21. Higher scores indicate a worse outcome
Measured: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
Numbers of suicide attempts
Suicide attempts recorded in the Norwegian Patient Registry (NPR).
Measured: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Numbers of suicides
Suicides recorded from the Norwegian Cause of Death Registry
Measured: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Number of admittances in psychiatric hospital
Admittances in psychiatric hospital recorded from Norwegian Patient Registry (NPR).
Measured: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Number of days in psychiatric hospital
Days in psychiatric hospital recorded from Norwegian Patient Registry (NPR).
Measured: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Number of compulsory admissions
Compulsory admissions recorded from Norwegian Patient Registry (NPR).
Measured: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Number of voluntary admissions
Voluntary admissions recorded from Norwegian Patient Registry (NPR).
Measured: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start3 Jun 2024
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies 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
- Model description
- Patients acutely admitted to Department of acute psychiatry, St Olav University Hospital (SOH) or Levanger Hospital or acutely admitted to an outpatient team for acute and emergency psychiatry, SOH, or admitted to a district psychiatric centers (DPS) in Trøndelag county or evaluated by physicians or psychologists at the Consultation Liaison, SOH. Patients will be included with consecutive sampling of patients who meet the selection criteria and give an informed consent. Participants will be equally randomized (1:1) in the intervention and control group and randomization will take place by digital randomization using WebCRF (KlinForsk/ Klinisk forskningsenhet Midt-Norge). Stratified randomization will be used regarding the baseline variable "substance abuse", ensuring that this variable is more evenly distributed between the two groups than chance.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Katrine K Fjukstad, PhD, Principal investigator, Helse Nord Trøndelag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466356
- Sponsor's protocol ID
- 142708
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducational Course for Suicide Prevention - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06466356
- Acronym / sponsor ID
- 142708
- Conditions
- Suicide Prevention, Suicide Threat, Self Efficacy, Stress, Psychological, Psychiatric Emergency, Psychiatric Disorder
- Keywords
- Psychoeducation, Safety plan, Gatekeeper, Suicidal crisis syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Norwegian University of Science and Technology
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 20 Jun 2024 (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 plan is to include patients with a history of increased risk of suicide. In the aftermath of an episode of imminent suicide risk, patients will receive a psychoeducational course that entails information on different aspects of suicide-related topics, identifying triggers and detecting early warning signals for increased suicide risk. The course culminates in working on completing a individual safety plan to prevent an future increase in suicide risk. The course will incorporate both patients and their next of kin. The psychoeducational course will be compared to a control group where the patients receive one individual session with focus on a safety plan to evaluate the intervention. Both groups will receive treatment as usual (TAU) during both the acute phase and follow-up. The study will be conducted as a randomized controlled trial.
Detailed description
Patients will be included during admittance in the acute psychiatric ward or when in contact with the outpatient team for acute and emergency psychiatry. They will receive acute treatment and be placed on a waiting list until enough patients are included to start the intervention. Then the included patients will be randomized to either the psychoeducational course or the individual session. The course and the individual lessons start at the same time. Each group includes 8-10 participant to receive a group based psychoeducative intervention (three for patients, one for next of kin) and TAU.
The first session (2x45 min) focus on information on suicidal thoughts, mental pain, suicide attempts and suicide as a phenomenon with focus on vulnerability factors, risk development and development of the suicidal crisis syndrome. The second session (2x45 min) tackles identifying triggers for increase in suicide risk and suicidal impulses, detecting early warning signals for increased suicide risk and how to recognize the change as it happens. In the third session (3x45 min) patients work on completing the individual safety plan to prevent an increase in suicide risk. The plan includes "situations that may trigger increased risk", "how to recognize and communicate the increased risk" and "actions that may reduce or increase risk." Finally, the fourth and last session (2x45 min) is aimed at the next of kin that the group participant wants to attend. Patients do not attend this session. The next of kin receive a review of the information from the first two sessions, as well as focus on what the next of kin can or cannot do to help if the risk of suicide increases.
The control group receive one individual session with focus on suicide risk and safety plan with a psychologist or physician and TAU.
Randomization and masking of study groups Participants will be equally randomized (1:1) in the intervention and control group. Patients will be included during admittance in the acute psychiatric ward or when in contact with the outpatient team for acute and emergency psychiatry. The first randomization takes place when sixteen to twenty participants are included. Randomization will take place by manual randomization by an external person at the Research department at St. Olav Hospital in Trondheim. This ensures an equal distribution between the intervention group and the control group. The patient and treating clinician will be unblinded to treatment modality. To compensate for lack of blinding concerning the received treatment, the persons ratings, subsequent measurements and data collection at follow-up will be blinded to the treatment conditions to avoid confirmation bias. The statistical advisor will also be blinded to treatment modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients acutely admitted to Department of acute psychiatry, St Olav University Hospital (SOH) or Levanger Hospital or acutely admitted to an outpatient team for acute and emergency psychiatry, SOH, or admitted to a district psychiatric centers (DPS) in Trøndelag county or evaluated by physicians or psychologists at the Consultation Liaison, SOH. Patients will be included with consecutive sampling of patients who meet the selection criteria and give an informed consent. Participants will be equally randomized (1:1) in the intervention and control group and randomization will take place by digital randomization using WebCRF (KlinForsk/ Klinisk forskningsenhet Midt-Norge). Stratified randomization will be used regarding the baseline variable "substance abuse", ensuring that this variable is more evenly distributed between the two groups than chance.
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational group therapy | Experimental | Other: Psychoeducational Course for Suicide Prevention, Other: Treatment as usualGroup therapy session, 3 meetings. Each group includes 8-10 participant to receive a group based psychoeducative intervention (three for patients, one for next of kin) and TAU. |
| Individual therapy session | Active comparator | Other: Individual therapy session, Other: Treatment as usualThe participants in the control group receive one individual therapy session with focus on suicide risk and safety plan with a psychologist or physician and TAU |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a suicide attempt, suicidal behavior, or risk of suicidal behavior and a clinician evaluating that the patient has an intention to die
- Patients with a suicide attempt or suicidal behavior defined as "a self-inflicted, potentially injurious behavior with a non-fatal outcome for which there is evidence of intention of death and/or considered to have had or been close to a suicidal crisis syndrome.
Key exclusion criteria (6 listed)
- Not being sufficiently fluent in Norwegian to provide informed consent, valid responses on psychometric testing or to benefit from a psychoeducative course.
- A known diagnosis of ICD-10 F 60.3 (borderline personality disorder) with similar symptoms at previous admittances.
- Ongoing psychosis.
- A substance abuse condition to such a degree that they are unable to comply with the protocol and are considered to be at risk when attending psychoeducational courses.
- Organic brain disorders or mental disabilities in such a degree that they are unable to comply with the protocol.
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 |
|---|---|---|
| Psychoeducational Course for Suicide PreventionBaseline variables includes diagnosis using ICD-10 criteria for research and demographic variables such as age, sex, level of education and occupation. Following assessments will be used when including patients for the project: The General self-efficacy scale (GSE) with additional questions related to the theme of the psychoeducational topics, The mental pain questionnaire (MPQ, Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT) The Patient Health Questionnaire (PHQ-9), GAD-7, The SCS-Checklist and SCI-5. GSE, MPQ and PHQ-9 will be measured after intervention and after 6, 12, 24 and 60 months. | Other | Psychoeducational group therapy |
| Individual therapy sessionBaseline variables includes diagnosis using ICD-10 criteria for research and demographic variables such as age, sex, level of education and occupation. Following assessments will be used when including patients for the project: The General self-efficacy scale (GSE) with additional questions related to the theme of the psychoeducational topics, The mental pain questionnaire (MPQ, Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT) The Patient Health Questionnaire (PHQ-9), GAD-7, The SCS-Checklist and SCI-5. GSE, MPQ and PHQ-9 will be measured after intervention and after 6, 12, 24 and 60 months. | Other | Individual therapy session |
| Treatment as usualTreatment as usual (TAU) may include the use of psychotropic drugs, in and out-patient treatment, occupational therapy and other interventions the patients physician deem necessary. | Other | Individual therapy session, Psychoeducational group therapy |
Primary outcome
Self efficacy
Time frame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
The General self-efficacy scale (GSE) measures optimistic self-beliefs in coping with the demands, tasks and challenges of life in general. It consists of 10 statements that respondents rate on a scale from 1 (not at all true) to 4 (exactly true). The individual's scores on each item are summed up to a GSE score with higher scores indicating higher GSE. Questions regarding the perceived efficacy regarding handling future episodes of increased suicide is added. An increase of ≥ 5 points on the GSE scale is considered the limit for a minimally clinically important change.
9 secondary outcomes
Mental pain
Time frame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
Symptoms of depression
Time frame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
Symptoms of anxiety
Time frame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.
Numbers of suicide attempts
Time frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Numbers of suicides
Time frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Number of admittances in psychiatric hospital
Time frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Number of days in psychiatric hospital
Time frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Number of compulsory admissions
Time frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
Number of voluntary admissions
Time frame: At 6, 12, 24 and 60 months after the completion of the course/individual sessions.
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 21 Jul 2026.
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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.
Thine Rishaug, MD contact
Katrine K Fjukstad, PhD principal investigator
Helse Nord Trøndelag
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational Course for Suicide Prevention, Individual therapy session and Treatment as usual in people with Suicide Prevention and Suicide Threat, run by St. Olavs Hospital at 2 sites in Norway.
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 2 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Contact Katrine K Fjukstad, PhD (+4774098600, katrine.k.fjukstad@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self efficacy (time frame: Immediately after completing the course/ individual sessions. Thereafter within one month after 6, 12, 24 and 60 months after completing the course/ individual sessions.). 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 21 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.