Treatment-resistant Depression (TRD)PSI-GROUPNCT07737990
Psilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression
A study testing Group integration therapy in people with Treatment-resistant Depression (TRD), run by Joshua Rosenblat at 1 site in Canada.
Trial summary
Psilocybin-assisted psychotherapy requires a lot of resources, with more psychotherapy being provided to integrate the meanings and insights derived from the psilocybin dosing sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment-resistant Depression (TRD)
- What is being tested?
- Group integration therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2026to 30 Jun 2030
- 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
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures;
- Stated willingness to comply with group integration requirements (i.e., maintaining confidentiality of other group members and group etiquette);
- Stated willingness to commit to attending all group sessions. Of note, participants who miss a group session will not be penalized, provided they have communicated their anticipated or unanticipated absence with the study therapist(s);
- Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form, study questionnaires and group participation, as evaluated by study staff obtaining consent;
Show all 9Show fewer
- Met all the inclusion criteria and none of the exclusion criteria of either the PSI-1V2 or Psilo-BD clinical trials.
- Completed the Primary Endpoint measures as part of the PSI-1V2 or Psilo-BD clinical trials.
- Participants who are actively receiving therapy outside of this study are eligible to participate, provided the external therapy they are receiving is not psilocybin-assisted group integration psychotherapy.
Who cannot join
- Active suicidal ideation as determined by the C-SSRS and/or clinical interview (significant suicide risk is defined by suicidal ideation as endorsed by items 4 or 5 of the C-SSRS) or active suicidality requiring involuntary inpatient treatment or recent suicide attempts within the past month;
- Withdrawal, dropout, loss to follow-up, or demonstrated significant study intervention non-compliance of either the PSI-1V2 or Psilo-BD clinical trials.
- Any behaviors that, in the opinion of the investigator, may interfere with the group therapy model (e.g., participants in acute crisis, demonstrated resistance to the therapeutic process of the main clinical trials, etc.);
- Participants who are actively receiving psilocybin-assisted group integration psychotherapy outside of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Psilocybin-assisted psychotherapy requires a lot of resources, with more psychotherapy being provided to integrate the meanings and insights derived from the psilocybin dosing sessions. If group integration therapy is beneficial, then it has the potential to reduce resources required per patient for psilocybin-assisted psychotherapy, thereby increasing the cost-effectiveness of the treatment. However, no research has been done to understand if and how group therapy can support psychedelic integration for people with mood disorders. Therefore, the purpose of this study is to explore the benefit of psilocybin-assisted group therapy and to determine if psychedelic group integration therapy is acceptable to people who have received psychedelic-assisted therapy for mood disorders.
Read the detailed description
This study is a phase II, single-arm, single-site, 21-week study evaluating efficacy, feasibility, and acceptability of psychedelic group integration therapy. Participants will join 10 group therapy sessions that will facilitate the integration of insights gained from PAP into their day-to-day lives. The study will explore pre- and post- intervention measures and integrate qualitative data with quantitative data to examine feasibility and efficacy.
- Conditions
- Treatment-resistant Depression (TRD)
- Being tested
- Group integration therapy
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group integration therapyOther
The integration group will consist of 4-8 participants who have completed PAP in accordance with the primary clinical trial (PSI-1V2 or Psilo-BD, respectively). One to two therapist(s) delegated to provide PAP as part of the primary clinical trials will facilitate the group and will guide the group in exploring a new psychoeducation theme each week. There will be a total of 10 sessions, each lasting 90 minutes. During the sessions, participants will experiment with interpreting their psychedelic experience through different lenses, as it relates to their depression. The group will take a peer-support format with group members collaboratively cultivating personally optimized perspectives from their dosing sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group Integration Therapy | Other | Not described Receives: Other: Group integration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on Behavioural Engagement with Integration
Evaluated using the Integration Engagement Scale, a 12-item self-report rating scale, where higher scores indicate greater engagement.
Measured: From enrolment to the primary endpoint (Week 21)
Secondary outcomes (6)
Self-Reported Depression Symptoms
Self-assessment of depression symptoms using the 16-Item Quick Inventory for Depression Symptomatology where higher scores indicate greater severity
Measured: From enrolment to the end of the program (Week 17)
Self-Reported Wellbeing
Self-assessment of psychological wellbeing using the 5-Item World Health Organization-Five Well-Being Index where higher scores indicate greater quality of life
Measured: From enrolment to the end of the program (Week 17)
Self-Reported Anxiety Symptoms
Self-assessment of anxiety symptoms using the Generalized Anxiety Disorder 7-Item where higher scores indicate greater severity.
Measured: From enrolment to the end of the program (Week 17)
Self-Report of the Intrapsychic Experience of Integration
Self-assessment of feeling harmonized and improved using the 12-item Experienced Integration Scale, where higher scores indicate greater improvements
Measured: From enrolment to the primary endpoint (Week 21)
Post-Psychedelic Growth
Self-report of positive changes following a psychedelic event using the Post-Psychedelic Growth Inventory, where greater scores indicate greater positive changes
Measured: From enrolment to the primary end point (Week 21)
Self-Reported Connectedness
Self-assessment of sense of connectedness to self, others and the world using the Watts Connectedness Scale, where higher scores indicate greater feelings of connectedness
Measured: From enrolment to primary endpoint (Week 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Treatment-resistant Depression (TRD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua Rosenblat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Rosenblat, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737990
- Sponsor's protocol ID
- 26-5068
- Acronym
- PSI-GROUP
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhdanava M, Pilon D, Ghelerter I, Chow W, Joshi K, Lefebvre P, Sheehan JJ. The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States. J Clin Psychiatry. 2021 Mar 16;82(2):20m13699. doi: 10.4088/JCP.20m13699.
PubMed 33989464Wong S, Kwan ATH, Teopiz KM, Le GH, Meshkat S, Ho R, d'Andrea G, Cao B, Di Vincenzo JD, Rosenblat JD, McIntyre RS. A comparison between psilocybin and esketamine in treatment-resistant depression using number needed to treat (NNT): A systematic review. J Affect Disord. 2024 Apr 1;350:698-705. doi: 10.1016/j.jad.2024.01.142. Epub 2024 Jan 18.
PubMed 38244804Scott F, Hampsey E, Gnanapragasam S, Carter B, Marwood L, Taylor RW, Emre C, Korotkova L, Martin-Dombrowski J, Cleare AJ, Young AH, Strawbridge R. Systematic review and meta-analysis of augmentation and combination treatments for early-stage treatment-resistant depression. J Psychopharmacol. 2023 Mar;37(3):268-278. doi: 10.1177/02698811221104058. Epub 2022 Jul 21.
PubMed 35861202Tyls, F., Palenicek, T., & Horacek, J. (2016). Neurobiology of the effects of psilocybin in relation to its potential therapeutic targets. In Preedy, V. R. (Ed.), Neuropathology of drug addictions and substance misuse: Volume 2: Stimulants, club and dissociative drugs, hallucinogens, steroids, inhalants and international aspects. (pp. 782-793). Elsevier eBooks. https://doi.org/10.1016/B978-0-12-800212-4.00073-X
Trope A, Anderson BT, Hooker AR, Glick G, Stauffer C, Woolley JD. Psychedelic-Assisted Group Therapy: A Systematic Review. J Psychoactive Drugs. 2019 Apr-Jun;51(2):174-188. doi: 10.1080/02791072.2019.1593559. Epub 2019 Apr 5.
PubMed 30950777Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Tai SJ, Nielson EM, Lennard-Jones M, Johanna Ajantaival RL, Winzer R, Richards WA, Reinholdt F, Richards BD, Gasser P, Malievskaia E. Development and Evaluation of a Therapist Training Program for Psilocybin Therapy for Treatment-Resistant Depression in Clinical Research. Front Psychiatry. 2021 Feb 3;12:586682. doi: 10.3389/fpsyt.2021.586682. eCollection 2021.
PubMed 33643087Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.
PubMed 12946886Rosenblat, J. D. (2024b). Neurobiological effects of psilocybin in treatment resistant bipolar depression (Psilo-BD). ClinicalTrials.gov Identifier: NCT06506019. Updated October 18, 2024. Accessed June 23, 2025. https://clinicaltrials.gov/study/NCT06506019
Rosenblat, J. D. (2024a). Psilocybin-assisted psychotherapy for treatment-resistant depression: Comparing one versus two doses of psilocybin (PSI-1V2). ClinicalTrials.gov Identifier: NCT06341426. Updated April 2, 2024. Accessed June 11, 2025. https://clinicaltrials.gov/study/NCT06341426
Perez N, Langlest F, Mallet L, De Pieri M, Sentissi O, Thorens G, Seragnoli F, Zullino D, Kirschner M, Kaiser S, Solmi M, Sabe M. Psilocybin-assisted therapy for depression: A systematic review and dose-response meta-analysis of human studies. Eur Neuropsychopharmacol. 2023 Nov;76:61-76. doi: 10.1016/j.euroneuro.2023.07.011. Epub 2023 Aug 7.
PubMed 37557019Naidoo N, Nguyen VT, Ravaud P, Young B, Amiel P, Schante D, Clarke M, Boutron I. The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence. BMC Med. 2020 Jan 20;18(1):6. doi: 10.1186/s12916-019-1476-5.
PubMed 31955710McIntyre RS, Alsuwaidan M, Baune BT, Berk M, Demyttenaere K, Goldberg JF, Gorwood P, Ho R, Kasper S, Kennedy SH, Ly-Uson J, Mansur RB, McAllister-Williams RH, Murrough JW, Nemeroff CB, Nierenberg AA, Rosenblat JD, Sanacora G, Schatzberg AF, Shelton R, Stahl SM, Trivedi MH, Vieta E, Vinberg M, Williams N, Young AH, Maj M. Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions. World Psychiatry. 2023 Oct;22(3):394-412. doi: 10.1002/wps.21120.
PubMed 37713549McDermut, W., Miller, I. W., & Brown, R. A. (2001). The efficacy of group psychotherapy for depression: A meta-analysis and review of the empirical research. American Psychological Association, 8(1), 98-116. https://psycnet.apa.org/doi/10.1093/clipsy.8.1.98
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT07737990
- Acronym / sponsor ID
- PSI-GROUP / 26-5068
- Conditions
- Treatment-resistant Depression (TRD)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Joshua RosenblatUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 30 Jul 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.
Psilocybin-assisted psychotherapy requires a lot of resources, with more psychotherapy being provided to integrate the meanings and insights derived from the psilocybin dosing sessions. If group integration therapy is beneficial, then it has the potential to reduce resources required per patient for psilocybin-assisted psychotherapy, thereby increasing the cost-effectiveness of the treatment. However, no research has been done to understand if and how group therapy can support psychedelic integration for people with mood disorders. Therefore, the purpose of this study is to explore the benefit of psilocybin-assisted group therapy and to determine if psychedelic group integration therapy is acceptable to people who have received psychedelic-assisted therapy for mood disorders.
Detailed description
This study is a phase II, single-arm, single-site, 21-week study evaluating efficacy, feasibility, and acceptability of psychedelic group integration therapy. Participants will join 10 group therapy sessions that will facilitate the integration of insights gained from PAP into their day-to-day lives. The study will explore pre- and post- intervention measures and integrate qualitative data with quantitative data to examine feasibility and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Integration Therapy | Other | Other: Group integration therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures;
- Stated willingness to comply with group integration requirements (i.e., maintaining confidentiality of other group members and group etiquette);
- Stated willingness to commit to attending all group sessions. Of note, participants who miss a group session will not be penalized, provided they have communicated their anticipated or unanticipated absence with the study therapist(s);
Key exclusion criteria (4 listed)
- Active suicidal ideation as determined by the C-SSRS and/or clinical interview (significant suicide risk is defined by suicidal ideation as endorsed by items 4 or 5 of the C-SSRS) or active suicidality requiring involuntary inpatient treatment or recent suicide attempts within the past month;
- Withdrawal, dropout, loss to follow-up, or demonstrated significant study intervention non-compliance of either the PSI-1V2 or Psilo-BD clinical trials.
- Any behaviors that, in the opinion of the investigator, may interfere with the group therapy model (e.g., participants in acute crisis, demonstrated resistance to the therapeutic process of the main clinical trials, etc.);
- Participants who are actively receiving psilocybin-assisted group integration psychotherapy outside of the study.
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 |
|---|---|---|
| Group integration therapyThe integration group will consist of 4-8 participants who have completed PAP in accordance with the primary clinical trial (PSI-1V2 or Psilo-BD, respectively). One to two therapist(s) delegated to provide PAP as part of the primary clinical trials will facilitate the group and will guide the group in exploring a new psychoeducation theme each week. There will be a total of 10 sessions, each lasting 90 minutes. During the sessions, participants will experiment with interpreting their psychedelic experience through different lenses, as it relates to their depression. The group will take a peer-support format with group members collaboratively cultivating personally optimized perspectives from their dosing sessions. | Other | Group Integration Therapy |
Primary outcome
Impact on Behavioural Engagement with Integration
Time frame: From enrolment to the primary endpoint (Week 21)
Evaluated using the Integration Engagement Scale, a 12-item self-report rating scale, where higher scores indicate greater engagement.
6 secondary outcomes
Self-Reported Depression Symptoms
Time frame: From enrolment to the end of the program (Week 17)
Self-Reported Wellbeing
Time frame: From enrolment to the end of the program (Week 17)
Self-Reported Anxiety Symptoms
Time frame: From enrolment to the end of the program (Week 17)
Self-Report of the Intrapsychic Experience of Integration
Time frame: From enrolment to the primary endpoint (Week 21)
Post-Psychedelic Growth
Time frame: From enrolment to the primary end point (Week 21)
Self-Reported Connectedness
Time frame: From enrolment to primary endpoint (Week 21)
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 30 Jul 2026.
- Background: PubMed 33989464Zhdanava M, Pilon D, Ghelerter I, Chow W, Joshi K, Lefebvre P, Sheehan JJ. The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States. J Clin Psychiatry. 2021 Mar 16;82(2):20m13699. doi: 10.4088/JCP.20m13699.
- Background: PubMed 38244804Wong S, Kwan ATH, Teopiz KM, Le GH, Meshkat S, Ho R, d'Andrea G, Cao B, Di Vincenzo JD, Rosenblat JD, McIntyre RS. A comparison between psilocybin and esketamine in treatment-resistant depression using number needed to treat (NNT): A systematic review. J Affect Disord. 2024 Apr 1;350:698-705. doi: 10.1016/j.jad.2024.01.142. Epub 2024 Jan 18.
- Background: PubMed 35861202Scott F, Hampsey E, Gnanapragasam S, Carter B, Marwood L, Taylor RW, Emre C, Korotkova L, Martin-Dombrowski J, Cleare AJ, Young AH, Strawbridge R. Systematic review and meta-analysis of augmentation and combination treatments for early-stage treatment-resistant depression. J Psychopharmacol. 2023 Mar;37(3):268-278. doi: 10.1177/02698811221104058. Epub 2022 Jul 21.
- BackgroundTyls, F., Palenicek, T., & Horacek, J. (2016). Neurobiology of the effects of psilocybin in relation to its potential therapeutic targets. In Preedy, V. R. (Ed.), Neuropathology of drug addictions and substance misuse: Volume 2: Stimulants, club and dissociative drugs, hallucinogens, steroids, inhalants and international aspects. (pp. 782-793). Elsevier eBooks. https://doi.org/10.1016/B978-0-12-800212-4.00073-X
- Background: PubMed 30950777Trope A, Anderson BT, Hooker AR, Glick G, Stauffer C, Woolley JD. Psychedelic-Assisted Group Therapy: A Systematic Review. J Psychoactive Drugs. 2019 Apr-Jun;51(2):174-188. doi: 10.1080/02791072.2019.1593559. Epub 2019 Apr 5.
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Background: PubMed 33643087Tai SJ, Nielson EM, Lennard-Jones M, Johanna Ajantaival RL, Winzer R, Richards WA, Reinholdt F, Richards BD, Gasser P, Malievskaia E. Development and Evaluation of a Therapist Training Program for Psilocybin Therapy for Treatment-Resistant Depression in Clinical Research. Front Psychiatry. 2021 Feb 3;12:586682. doi: 10.3389/fpsyt.2021.586682. eCollection 2021.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 12946886Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.
- BackgroundRosenblat, J. D. (2024b). Neurobiological effects of psilocybin in treatment resistant bipolar depression (Psilo-BD). ClinicalTrials.gov Identifier: NCT06506019. Updated October 18, 2024. Accessed June 23, 2025. https://clinicaltrials.gov/study/NCT06506019
- BackgroundRosenblat, J. D. (2024a). Psilocybin-assisted psychotherapy for treatment-resistant depression: Comparing one versus two doses of psilocybin (PSI-1V2). ClinicalTrials.gov Identifier: NCT06341426. Updated April 2, 2024. Accessed June 11, 2025. https://clinicaltrials.gov/study/NCT06341426
- Background: PubMed 37557019Perez N, Langlest F, Mallet L, De Pieri M, Sentissi O, Thorens G, Seragnoli F, Zullino D, Kirschner M, Kaiser S, Solmi M, Sabe M. Psilocybin-assisted therapy for depression: A systematic review and dose-response meta-analysis of human studies. Eur Neuropsychopharmacol. 2023 Nov;76:61-76. doi: 10.1016/j.euroneuro.2023.07.011. Epub 2023 Aug 7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group integration therapy in people with Treatment-resistant Depression (TRD), run by Joshua Rosenblat at 1 site in Canada.
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 9 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 30 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 1 site in Canada. 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?
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?
Impact on Behavioural Engagement with Integration (time frame: From enrolment to the primary endpoint (Week 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07737990, which also lists 44 linked publications.
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 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.