Mental DisorderRNTACTSwedenNCT05946382

A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.

A study testing RNT-ACT Protocol and iCBT Treatment in people with Mental Disorder and Mental Health Issue, run by Region Skane at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Mental Disorder, Mental Health Issue, Mental Depression
What is being tested?: RNT-ACT Protocol and iCBT Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteSweden
Study dates: 7 Feb 2024to 25 May 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

DASS-21 total score >20
Ability to communicate in spoken and written Swedish

Who cannot join

Physical illness requiring further medical assessment identified during routine screening
Ongoing psychological or psychiatric treatment
A level of suicide risk considered clinically incompatible with study participation
Substance abuse
Anorexia nervosa
Psychotic disorder

Show all 10Show fewer

Bipolar disorder
Attention-deficit/hyperactivity disorder (ADHD)
Antisocial personality disorder
A level of exhaustion considered incompatible with study participation

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Vårdcentralen Laröd
Helsingborg, Skåne County, 254 83

Other trials in Sweden

About this study

Official title: A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress: a Pilot Randomized Controlled Trial.

This pilot randomized controlled trial evaluated the feasibility of a Swedish translation of an Acceptance and Commitment Therapy protocol targeting repetitive negative thinking (RNT-ACT) compared with therapist-supported internet-based cognitive behavioral therapy (iCBT) in Swedish primary care. Feasibility was assessed in terms of recruitment, intervention completion, and patient satisfaction. Symptoms of depression, anxiety and stress, rumination, psychological flexibility, valued living, and cognitive fusion were assessed as secondary outcomes.

Read the detailed description

This pilot randomized controlled trial was conducted to evaluate the feasibility of RNT-ACT in Swedish primary care, using therapist-supported iCBT as an active comparator. Participants were randomized to either RNT-ACT or iCBT.

RNT-ACT consisted of two 60-minute therapy sessions and audio exercises for participants to use between sessions. Participants allocated to iCBT received an internet-based cognitive behavioral therapy program for anxiety or depression, delivered through the secure Stöd och Behandling platform used in Region Skåne, with therapist support available through the platform.

The primary feasibility outcomes were recruitment rate, intervention non-completion, and patient satisfaction measured with the Client Satisfaction Questionnaire (CSQ-8). Secondary outcomes included symptoms of depression, anxiety and stress, rumination, psychological flexibility, valued living, and cognitive fusion. Secondary outcomes were included to describe the sample and patterns of change and were not intended to provide evidence of comparative treatment efficacy.

Conditions: Mental Disorder, Mental Health Issue, Mental Depression, Anxiety, Mental Stress, Rumination - Thoughts
Being tested: RNT-ACT Protocol, iCBT Treatment
Medical subject headings: Mental Disorders, Depression, Anxiety Disorders, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RNT-ACT ProtocolBehavioural
Also called Acceptance and Commitment Therapy (ACT)
Swedish Translation of the 2*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.
iCBT TreatmentBehavioural
Therapist-supported internet-based Cognitive Behavioral Therapy (iCBT), provided as part of routine care in Swedish primary care and used as the active comparator.

Study groups in NCT05946382
Study group	Role	What they receive
RNT-ACT protocol	Experimental	Participants randomized to RNT-ACT will receive a total of 2 sessions of 60 minutes each as well as audio files to listen to between the occasions administered via internet. Previous studies have indicated that it doesn't make much of a difference whether the temporal distance between session 1 and session 2 is between 1 week and up to 3 months. At occasion 1, the time for occasion 2 is set. The temporal distance in days will noted for each patient. The treatment is inserted into the therapist's regular diary with 60 minutes session time and appropriate break before and after the treatment (e.g. at least 5-10 minutes) for preparation and post-administration where journal writing is included. Receives: Behavioral: RNT-ACT Protocol
iCBT treatment	Active comparator	The people randomized to Internet treatment will be offered based on M.I.N.I 7.0 a suitable iCBT program in the Stöd och Behandling (SoB) platform. The patients follow a structured self-help material which can be seen as a standard treatment option in Region Skåne, "treatment as usual". The therapist has access to the material and the patient and the therapist can communicate via a chat function. The patients are matched to iCBT programs based on whether they are most likely to show symptoms of depression or anxiety. The main component of Internet processing consists of a structured self-help program in approximately eight modules, somewhat varying depending on which program in use. The program is based on proven CBT interventions for each problem area with a strong emphasis on psychoeducation but where different intervention elements is included. Receives: Behavioral: iCBT Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment rate
Percentage of participants enrolled among all individuals screened for participation. Calculated as the number of participants enrolled divided by the total number of individuals screened, multiplied by 100.
Measured: At screening and enrolment.
Intervention non-completion rate
Percentage of randomized participants who did not complete their allocated intervention. Intervention completion was assessed as a binary outcome.
Measured: From randomization through completion of the allocated intervention, up to approximately 3 months.
CSQ-8
Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction.
Measured: At the main post-treatment follow-up; if not completed, at the 3-month follow-up.

Secondary outcomes (5)

DASS-21
Depression, Anxiety and Stress Scale-21 (DASS-21); Min 0, Max 63, with higher values indicating greater psychological distress.
Measured: At baseline, main post-treatment follow-up, and 3-month follow-up.
RRS-BR
Ruminative Responses Scale - Brooding and Reflection (RRS-BR). Total score range 10-40, with higher values indicating a greater tendency to ruminate.
Measured: At baseline, main post-treatment follow-up, and 3-month follow-up.
SAAQ
Swedish Acceptance and Action Questionnaire (SAAQ). Total score range 6-42, with higher values indicating greater psychological inflexibility.
Measured: At baseline, main post-treatment follow-up, and 3-month follow-up.
Valuing Questionnaire (VQ)
Valuing Questionnaire (VQ). A 10-item self-report measure of valued living comprising two subscales, Progress and Obstruction, five items each. Each subscale has a score range of 5-35. Higher Progress scores and lower Obstruction scores indicate greater valued living. Each item is rated on a seven-point Likert-type scale ranging from 1 (Not at all true) to 7 (Completely true).
Measured: At baseline, main post-treatment follow-up, and 3-month follow-up.
CFQ-7
Cognitive Fusion Questionnaire - 7 items (CFQ-7). Total score range 7-49, with higher values indicating greater cognitive fusion.
Measured: At baseline, main post-treatment follow-up, and 3-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 202425 May 2025

First posted14 Jul 2023
Study start7 Feb 2024
Primary completion20 Dec 2024
Study completion25 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Mental DisorderStudies of the same condition, open and under way.
More trials run by Region SkaneThe 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: Participants were randomized to one of two parallel intervention arms: RNT-ACT or therapist-supported iCBT. Participants were evaluated after completion of the allocated intervention and at 3-month follow-up.
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05946382
Sponsor's protocol ID: 2022-06465-01
Acronym: RNTACTSweden
Status last verified: Aug 2026
First submitted: 22 Jun 2023
Last updated: 22 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alfonsson S, Wallin E, Maathz P. Factor structure and validity of the Depression, Anxiety and Stress Scale-21 in Swedish translation. J Psychiatr Ment Health Nurs. 2017 Mar;24(2-3):154-162. doi: 10.1111/jpm.12363. Epub 2017 Jan 25.
PubMed 28124410
Amorim P, Lecrubier Y, Weiller E, Hergueta T, Sheehan D. DSM-IH-R Psychotic Disorders: procedural validity of the Mini International Neuropsychiatric Interview (MINI). Concordance and causes for discordance with the CIDI. Eur Psychiatry. 1998;13(1):26-34. doi: 10.1016/S0924-9338(97)86748-X.
PubMed 19698595
Andersson G, Titov N, Dear BF, Rozental A, Carlbring P. Internet-delivered psychological treatments: from innovation to implementation. World Psychiatry. 2019 Feb;18(1):20-28. doi: 10.1002/wps.20610.
PubMed 30600624
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
PubMed 10259963
Berger T, Urech A, Krieger T, Stolz T, Schulz A, Vincent A, Moser CT, Moritz S, Meyer B. Effects of a transdiagnostic unguided Internet intervention ('velibra') for anxiety disorders in primary care: results of a randomized controlled trial. Psychol Med. 2017 Jan;47(1):67-80. doi: 10.1017/S0033291716002270. Epub 2016 Sep 22.
PubMed 27655039
Donati MA, Berrocal C, Bernini O, Gori C, Primi C. Measuring cognitive fusion through the Cognitive Fusion Questionnaire-7: Measurement invariance across non-clinical and clinical psychological samples. PLoS One. 2021 Feb 3;16(2):e0246434. doi: 10.1371/journal.pone.0246434. eCollection 2021.
PubMed 33534868
Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
PubMed 24411117
Glasgow RE, Fisher L, Strycker LA, Hessler D, Toobert DJ, King DK, Jacobs T. Minimal intervention needed for change: definition, use, and value for improving health and health research. Transl Behav Med. 2014 Mar;4(1):26-33. doi: 10.1007/s13142-013-0232-1.
PubMed 24653774
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
PubMed 10245370
Lundgren T, Parling T. Swedish Acceptance and Action Questionnaire (SAAQ): a psychometric evaluation. Cogn Behav Ther. 2017 Jun;46(4):315-326. doi: 10.1080/16506073.2016.1250228. Epub 2016 Dec 9.
PubMed 27931161
Ruiz FJ, Pena-Vargas A, Ramirez ES, Suarez-Falcon JC, Garcia-Martin MB, Garcia-Beltran DM, Henao AM, Monroy-Cifuentes A, Sanchez PD. Efficacy of a two-session repetitive negative thinking-focused acceptance and commitment therapy (ACT) protocol for depression and generalized anxiety disorder: A randomized waitlist control trial. Psychotherapy (Chic). 2020 Sep;57(3):444-456. doi: 10.1037/pst0000273. Epub 2020 Jan 16.
PubMed 31944806
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
PubMed 9881538
Ehring, T., & Watkins, E. R. (2008). Repetitive negative thinking as a transdiagnostic process. International Journal of Cognitive Therapy, 1(3), 192-205. https://doi.org/10.1521/ijct.2008.1.3.192
Lecrubier, Y., Sheehan, D., Weiller, E., Amorim, P., Bonora, I., Sheehan, K., . . . Dunbar, G. (1997). The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: Reliability and validity according to the CIDI. European Psychiatry, 12(5), 224-231. doi:10.1016/S0924-9338(97)83296-8
O'Neill, L., Latchford, G., McCracken, L. M., & Graham, C. D. (2019). The development of the acceptance and commitment therapy fidelity measure (ACT-FM): A Delphi Study and field test. Journal of Contextual Behavioral Science, 14, 111-118. https://doi.org/10.1016/j.jcbs.2019.08.008

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress: a Pilot Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT05946382
Acronym / sponsor ID: RNTACTSweden / 2022-06465-01
Conditions: Mental Disorder, Mental Health Issue, Mental Depression, Anxiety, Mental Stress, Rumination - Thoughts
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Region SkaneUniversity, hospital or other
Collaborators: Lund University
Study start: 7 Feb 2024 (actual)
Primary completion: 20 Dec 2024 (actual)
Study completion: 25 May 2025 (actual)
First posted: 14 Jul 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants were randomized to one of two parallel intervention arms: RNT-ACT or therapist-supported iCBT. Participants were evaluated after completion of the allocated intervention and at 3-month follow-up.

Arm	Type	Receives
RNT-ACT protocol	Experimental	Behavioral: RNT-ACT ProtocolParticipants randomized to RNT-ACT will receive a total of 2 sessions of 60 minutes each as well as audio files to listen to between the occasions administered via internet. Previous studies have indicated that it doesn't make much of a difference whether the temporal distance between session 1 and session 2 is between 1 week and up to 3 months. At occasion 1, the time for occasion 2 is set. The temporal distance in days will noted for each patient. The treatment is inserted into the therapist's regular diary with 60 minutes session time and appropriate break before and after the treatment (e.g. at least 5-10 minutes) for preparation and post-administration where journal writing is included.
iCBT treatment	Active comparator	Behavioral: iCBT TreatmentThe people randomized to Internet treatment will be offered based on M.I.N.I 7.0 a suitable iCBT program in the Stöd och Behandling (SoB) platform. The patients follow a structured self-help material which can be seen as a standard treatment option in Region Skåne, "treatment as usual". The therapist has access to the material and the patient and the therapist can communicate via a chat function. The patients are matched to iCBT programs based on whether they are most likely to show symptoms of depression or anxiety. The main component of Internet processing consists of a structured self-help program in approximately eight modules, somewhat varying depending on which program in use. The program is based on proven CBT interventions for each problem area with a strong emphasis on psychoeducation but where different intervention elements is included.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

DASS-21 total score >20
Ability to communicate in spoken and written Swedish

Key exclusion criteria (10 listed)

Physical illness requiring further medical assessment identified during routine screening
Ongoing psychological or psychiatric treatment
A level of suicide risk considered clinically incompatible with study participation
Substance abuse
Anorexia nervosa

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
RNT-ACT ProtocolAlso: Acceptance and Commitment Therapy (ACT)Swedish Translation of the 2*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.	Behavioural	RNT-ACT protocol
iCBT TreatmentTherapist-supported internet-based Cognitive Behavioral Therapy (iCBT), provided as part of routine care in Swedish primary care and used as the active comparator.	Behavioural	iCBT treatment

Primary outcome

Recruitment rate
Time frame: At screening and enrolment.
Percentage of participants enrolled among all individuals screened for participation. Calculated as the number of participants enrolled divided by the total number of individuals screened, multiplied by 100.
Intervention non-completion rate
Time frame: From randomization through completion of the allocated intervention, up to approximately 3 months.
Percentage of randomized participants who did not complete their allocated intervention. Intervention completion was assessed as a binary outcome.
CSQ-8
Time frame: At the main post-treatment follow-up; if not completed, at the 3-month follow-up.
Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction.

5 secondary outcomes

DASS-21
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.
RRS-BR
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.
SAAQ
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.
Valuing Questionnaire (VQ)
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.
CFQ-7
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Background: PubMed 28124410Alfonsson S, Wallin E, Maathz P. Factor structure and validity of the Depression, Anxiety and Stress Scale-21 in Swedish translation. J Psychiatr Ment Health Nurs. 2017 Mar;24(2-3):154-162. doi: 10.1111/jpm.12363. Epub 2017 Jan 25.
Background: PubMed 19698595Amorim P, Lecrubier Y, Weiller E, Hergueta T, Sheehan D. DSM-IH-R Psychotic Disorders: procedural validity of the Mini International Neuropsychiatric Interview (MINI). Concordance and causes for discordance with the CIDI. Eur Psychiatry. 1998;13(1):26-34. doi: 10.1016/S0924-9338(97)86748-X.
Background: PubMed 30600624Andersson G, Titov N, Dear BF, Rozental A, Carlbring P. Internet-delivered psychological treatments: from innovation to implementation. World Psychiatry. 2019 Feb;18(1):20-28. doi: 10.1002/wps.20610.
Background: PubMed 10259963Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
Background: PubMed 27655039Berger T, Urech A, Krieger T, Stolz T, Schulz A, Vincent A, Moser CT, Moritz S, Meyer B. Effects of a transdiagnostic unguided Internet intervention ('velibra') for anxiety disorders in primary care: results of a randomized controlled trial. Psychol Med. 2017 Jan;47(1):67-80. doi: 10.1017/S0033291716002270. Epub 2016 Sep 22.
Background: PubMed 33534868Donati MA, Berrocal C, Bernini O, Gori C, Primi C. Measuring cognitive fusion through the Cognitive Fusion Questionnaire-7: Measurement invariance across non-clinical and clinical psychological samples. PLoS One. 2021 Feb 3;16(2):e0246434. doi: 10.1371/journal.pone.0246434. eCollection 2021.
Background: PubMed 24411117Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
Background: PubMed 24653774Glasgow RE, Fisher L, Strycker LA, Hessler D, Toobert DJ, King DK, Jacobs T. Minimal intervention needed for change: definition, use, and value for improving health and health research. Transl Behav Med. 2014 Mar;4(1):26-33. doi: 10.1007/s13142-013-0232-1.
Background: PubMed 10245370Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
Background: PubMed 27931161Lundgren T, Parling T. Swedish Acceptance and Action Questionnaire (SAAQ): a psychometric evaluation. Cogn Behav Ther. 2017 Jun;46(4):315-326. doi: 10.1080/16506073.2016.1250228. Epub 2016 Dec 9.
Background: PubMed 31944806Ruiz FJ, Pena-Vargas A, Ramirez ES, Suarez-Falcon JC, Garcia-Martin MB, Garcia-Beltran DM, Henao AM, Monroy-Cifuentes A, Sanchez PD. Efficacy of a two-session repetitive negative thinking-focused acceptance and commitment therapy (ACT) protocol for depression and generalized anxiety disorder: A randomized waitlist control trial. Psychotherapy (Chic). 2020 Sep;57(3):444-456. doi: 10.1037/pst0000273. Epub 2020 Jan 16.
Background: PubMed 9881538Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Client Satisfaction Questionnaire scalesLink provided by the sponsor.
Swedish platform for use of internet service in health careLink provided by the sponsor.
Social Psychology Network. Research randomizer.Link provided by the sponsor.
Swedish authority (Socialstyrelsen). April 2021. National guidelines for care in depression and anxiety disorders. Support for governance and management.Link provided by the sponsor.
Swedish authority (Socialstyrelsen) February 2018. Accessibility in health and healthcareLink provided by the sponsor.
Working Alliance Inventory.Link provided by the sponsor.
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. This study is not recruiting at the moment.

Veronica Milos Nymberg, PhD principal investigator

Lund University/Region Skåne

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RNT-ACT Protocol and iCBT Treatment in people with Mental Disorder and Mental Health Issue, run by Region Skane 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 2 inclusion and 10 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 22 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Recruitment rate (time frame: At screening and enrolment.). 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?

On the ClinicalTrials.gov record for NCT05946382, which also lists 19 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 22 Sep 2026.