Bipolar DisorderNCT06282250
Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder
A study testing Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy, Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy and Psycho-education + Imagery focused Cognitive Therapy in people with Bipolar Disorder and Mood Swing, run by Geestelijke Gezondheidszorg Eindhoven (GGzE) at 1 site in Netherlands.
Trial summary
In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Bipolar Disorder, Mood Swing, Prodromal Symptoms
- What is being tested?
- Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy, Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy and Psycho-education + Imagery focused Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2024to Dec 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must be bound to start the early intervention treatment being evaluated
- Aged 16-35, or > 35 by indication of the patients' treating clinician
- Found to be at risk for SMI, as determined by the Early Detection and Intervention Team of GGzE
- Sufficient knowledge of Dutch or English language
- Ability to give informed consent
- Willing to complete daily monitoring throughout the duration of the study
Who cannot join
- Learningdifficulties,organicbraindiseaseorsevereneurologicalimpairment.
- Previously received BLT (less than 3 weeks prior to study entry
- Current severe substance or alcohol misuse (clinicians' assessment)
- In case of BLT: eye problems contraindicating BLT and/or being unable to visit the GGzE
Trial locations and contacts
1 site in 1 country.
Liselore Snaphaan, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Geestelijke Gezondheidszorg Eindhoven (GGzE)
Eindhoven, North Brabant, 5626ND
Else Treffers, MSc, +31622559192, else.treffers@ggze.nl
About this study
Official title: An Explorative and Experimental Study to Assess the Feasibility, Acceptability, and Effectiveness of Early Intervention With Light, Lifestyle and ImCT Therapy in Individuals at Risk for Bipolar Disorder
In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. This intervention program entails psycho-education, light and lifestyle therapy in combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm and lifestyle factors such as activity level. We hypothesize a relationship between this early intervention and a significant improvement in mood symptoms, anxiety, subjective and objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and associations with clinical improvement of symptoms will be studied.
Additionally, in a separate validation study, data will be collected to validate a new instrument for the early detection of those at risk for bipolar disorders. The Semistructured Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and colleagues.
Read the detailed description
Severe mental illnesses (SMI) distinguished as bipolar disorder and psychotic spectrum disorders, substantially impair patients' engagement in functional and occupational activities and severely limit social and societal functioning (GGZ Standaarden, 2022; NIH, 2022; NIMH, 2018). Based on the Dutch definition of SMI 1.7% of the national population suffers from an SMI (GGZ Standaarden, 2022). Despite this, time between first symptoms and accurate SMI diagnosis, can add up to more than 9.5 years in the case of bipolar disorders. For the psychotic spectrum, an early detection and intervention program (UHR) carried out by special EDI-Teams already exists, and has been found effective in limiting the transition to SMI with fifty percent. For bipolar disorders, no such program exists. This raises the question whether prodromal and subclinical symptoms of this disorder can be detected earlier and if transition into SMI can be limited. In light of current studies into the at-risk mental state, and the current development towards a possible transdiagnostic model for early detection and intervention of SMI (CHARMS-categories; (Liu et al., 2022)), the current study aims to contribute to limiting the transition into bipolar disorder. As a disturbance in circadian rhythm, as well as mood and anxiety symptoms are risk indicators for SMI in general and bipolar in specific, the current study evaluates an early intervention program for individuals at risk for developing an SMI, with a focus on bipolar symptomatology.
Individuals at risk will answer questions from the SIBARS interview. As explained in a publication of Fusar-Poli et al. (2022), "The Semi-structured Interview for Bipolar At Risk States (SIBARS) included a combination of several items adapted from well-established rating scales: (CAARMS (Yung et al., 2005); Hypomania Checklist-32 (Angst et al., 2005); Altman Self-Rating Mania Scale (Altman et al., 1997); TEMPS-A questionnaire (Akiskal et al., 2005); QIDS-SR (Rush et al., 2003); Bergen Insomnia Scale (Pallesen et al., 2008); Idiopathic hypersomnia questionnaire (Vernet et al., 2010)). The SIBARS interview was developed for youths aged 15-35 and comprehended 5 domains: 1. Subtreshold Mania, 2. Depression, 3. Cyclothymic Features, 4. Genetic Risk, 5. Mood Swings. Subtreshold Mania, Depression and Mood Swings are continuous rating scales (that include a severity and frequency anchors), while Cyclothyimc Features and Genetic Risk are categorical scales (yes/no). The cut-offs allow assigning the specific subgroup of the BARS criteria: 1. Substreshold Mania, 2. Depression+Cyclothymic Features, 3. Depression+Genetic Risk, 4. Cyclothymic Features+Genetic Risk, 5.Subtreshold Mixed Episode, 6. Mood Swings."
- Conditions
- Bipolar Disorder, Mood Swing, Prodromal Symptoms
- Being tested
- Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy, Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy, Psycho-education + Imagery focused Cognitive Therapy
- Keywords
- Bipolar disorder, Early intervention, Light therapy, Early detection, Lifestyle, Imagery Focused Cognitive Therapy
- Medical subject headings
- Bipolar Disorder, Prodromal Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright light therapy + Psycho-education + Imagery focused Cognitive TherapyBehavioural
Week 1-3: BLT will be administered for 30 minutes on five consecutive days, starting on Monday of the work week, between 7:30 AM and 10:00. The effect of the light therapy is evaluated by means of the Self-Rated Quick Inventory of Depressive Symptoms (QIDS-SR). Further treatment strategy is determined on the basis of these results:
- If the patient has achieved remission (QIDS-SR < 6), BLT has been successful and the patient can continue with PE and IMCT.
- If there is insufficient or no response (QIDS-SR of 6 or higher), BLT is extended with five more sessions the following week.
- If necessary, a third week is optional.
Week 2-4: Psycho Education will follow, 1 session.
Week 3/4-9/10: ImCT will follow, 6 sessions.
Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive TherapyBehavioural
Week 1-3: blue-light blocking glasses will be administered. Week 2-4: Psycho Education will follow, 1 session.
Week 3/4-9/10: ImCT will follow, 6 sessions.
Psycho-education + Imagery focused Cognitive TherapyBehavioural
Week 1: Psycho Education, 1 session.
Week 2-7: ImCT will follow, 6 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Psycho-education and Imagery Focused Cognitive Therapy (in addition to Bright Light Therapy) | Other | Treatment will be personalized in accordance to one of three options:
1. In case of depressive symptoms.
Bright Light Therapy (BLT) will be administered for 30 minutes on five consecutive days (duration: 1-3 weeks).
1 PE session focused on lifestyle and physical activity will take place. 6 sessions of ImCT will take place. This includes in-depth identification of images, constructing a micro-formulation along the lines of regular Cognitive Behavioural Therapy.
2. In case of hyperactivity symptoms.
The same PE and ImCT will be administered. The exception is that in this case, BLT is replaced by wearing blue-light blocking glasses for 1-3 weeks, 1 hour prior to bedtime.
3. In case of at risk mental state, but no clear depressive or hyperactive symptoms.
The same PE and ImCT will be administered. There will be no light intervention. Receives: Behavioral: Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy; Behavioral: Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy; Behavioral: Psycho-education + Imagery focused Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptom scores on the IDS-SR
Significant lowering of IDS-SR questionnaire scores
Measured: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Change in hyperactive symptom scores on the ASRM
Significant lowering of ASRM questionnaire scores
Measured: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Change in anxiety symptom scores on the BAI
Significant lowering of BAI questionnaire scores
Measured: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Change in sleep quality subjective rating on 11-point Likert scale
Significant improvement in subjective rating of sleep quality questionnaires
Measured: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Change in activity levels subjective rating on 11-point Likert scale
Changes in daily and pre-post intervention self-report measurement of activity levels
Measured: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startMay 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geestelijke Gezondheidszorg Eindhoven (GGzE)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Else Treffers, Geestelijke Gezondheidszorg Eindhoven (GGzE)
- Investigators
- Inge Bongers, Prof. Dr., Principal investigator, GGzE, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282250
- Sponsor's protocol ID
- in progress
- Status last verified
- Apr 2024
- First submitted
- 3 Jul 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data is generated at the research location and is not shared with other researchers working elsewhere. After publication of the results, only data without privacy sensitive information and without study specific codes (fully anonymous), that support the findings are available from GGzE upon reasonable request (both in and outside the European Union). Before sharing this anonymous data, GGzE carefully investigates this request in consideration of the Dutch AVG and UAVG (Dutch Act on Implementation of the General Data Protection Regulation).
Publications
Treffers E, Snaphaan L, van den Berg KC, Bongers IMB. A study protocol for the feasibility and acceptability of a personalized early intervention combining light therapy, lifestyle psychoeducation, and imagery-focused cognitive therapy in individuals at risk for bipolar disorder. Int J Bipolar Disord. 2026 Jan 22;14(1):8. doi: 10.1186/s40345-026-00410-4.
PubMed 41572055
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative and Experimental Study to Assess the Feasibility, Acceptability, and Effectiveness of Early Intervention With Light, Lifestyle and ImCT Therapy in Individuals at Risk for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06282250
- Acronym / sponsor ID
- in progress
- Conditions
- Bipolar Disorder, Mood Swing, Prodromal Symptoms
- Keywords
- Bipolar disorder, Early intervention, Light therapy, Early detection, Lifestyle, Imagery Focused Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Geestelijke Gezondheidszorg Eindhoven (GGzE)University, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Feb 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.
In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. This intervention program entails psycho-education, light and lifestyle therapy in combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm and lifestyle factors such as activity level. We hypothesize a relationship between this early intervention and a significant improvement in mood symptoms, anxiety, subjective and objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and associations with clinical improvement of symptoms will be studied.
Additionally, in a separate validation study, data will be collected to validate a new instrument for the early detection of those at risk for bipolar disorders. The Semistructured Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and colleagues.
Detailed description
Severe mental illnesses (SMI) distinguished as bipolar disorder and psychotic spectrum disorders, substantially impair patients' engagement in functional and occupational activities and severely limit social and societal functioning (GGZ Standaarden, 2022; NIH, 2022; NIMH, 2018). Based on the Dutch definition of SMI 1.7% of the national population suffers from an SMI (GGZ Standaarden, 2022). Despite this, time between first symptoms and accurate SMI diagnosis, can add up to more than 9.5 years in the case of bipolar disorders. For the psychotic spectrum, an early detection and intervention program (UHR) carried out by special EDI-Teams already exists, and has been found effective in limiting the transition to SMI with fifty percent. For bipolar disorders, no such program exists. This raises the question whether prodromal and subclinical symptoms of this disorder can be detected earlier and if transition into SMI can be limited. In light of current studies into the at-risk mental state, and the current development towards a possible transdiagnostic model for early detection and intervention of SMI (CHARMS-categories; (Liu et al., 2022)), the current study aims to contribute to limiting the transition into bipolar disorder. As a disturbance in circadian rhythm, as well as mood and anxiety symptoms are risk indicators for SMI in general and bipolar in specific, the current study evaluates an early intervention program for individuals at risk for developing an SMI, with a focus on bipolar symptomatology.
Individuals at risk will answer questions from the SIBARS interview. As explained in a publication of Fusar-Poli et al. (2022), "The Semi-structured Interview for Bipolar At Risk States (SIBARS) included a combination of several items adapted from well-established rating scales: (CAARMS (Yung et al., 2005); Hypomania Checklist-32 (Angst et al., 2005); Altman Self-Rating Mania Scale (Altman et al., 1997); TEMPS-A questionnaire (Akiskal et al., 2005); QIDS-SR (Rush et al., 2003); Bergen Insomnia Scale (Pallesen et al., 2008); Idiopathic hypersomnia questionnaire (Vernet et al., 2010)). The SIBARS interview was developed for youths aged 15-35 and comprehended 5 domains: 1. Subtreshold Mania, 2. Depression, 3. Cyclothymic Features, 4. Genetic Risk, 5. Mood Swings. Subtreshold Mania, Depression and Mood Swings are continuous rating scales (that include a severity and frequency anchors), while Cyclothyimc Features and Genetic Risk are categorical scales (yes/no). The cut-offs allow assigning the specific subgroup of the BARS criteria: 1. Substreshold Mania, 2. Depression+Cyclothymic Features, 3. Depression+Genetic Risk, 4. Cyclothymic Features+Genetic Risk, 5.Subtreshold Mixed Episode, 6. Mood Swings."
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psycho-education and Imagery Focused Cognitive Therapy (in addition to Bright Light Therapy) | Other | Behavioral: Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy, Behavioral: Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy, Behavioral: Psycho-education + Imagery focused Cognitive TherapyTreatment will be personalized in accordance to one of three options: 1. In case of depressive symptoms. Bright Light Therapy (BLT) will be administered for 30 minutes on five consecutive days (duration: 1-3 weeks). 1 PE session focused on lifestyle and physical activity will take place. 6 sessions of ImCT will take place. This includes in-depth identification of images, constructing a micro-formulation along the lines of regular Cognitive Behavioural Therapy. 2. In case of hyperactivity symptoms. The same PE and ImCT will be administered. The exception is that in this case, BLT is replaced by wearing blue-light blocking glasses for 1-3 weeks, 1 hour prior to bedtime. 3. In case of at risk mental state, but no clear depressive or hyperactive symptoms. The same PE and ImCT will be administered. There will be no light intervention. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Must be bound to start the early intervention treatment being evaluated
- Aged 16-35, or > 35 by indication of the patients' treating clinician
- Found to be at risk for SMI, as determined by the Early Detection and Intervention Team of GGzE
- Sufficient knowledge of Dutch or English language
- Ability to give informed consent
Key exclusion criteria (4 listed)
- Learningdifficulties,organicbraindiseaseorsevereneurologicalimpairment.
- Previously received BLT (less than 3 weeks prior to study entry
- Current severe substance or alcohol misuse (clinicians' assessment)
- In case of BLT: eye problems contraindicating BLT and/or being unable to visit the GGzE
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 |
|---|---|---|
| Bright light therapy + Psycho-education + Imagery focused Cognitive TherapyWeek 1-3: BLT will be administered for 30 minutes on five consecutive days, starting on Monday of the work week, between 7:30 AM and 10:00. The effect of the light therapy is evaluated by means of the Self-Rated Quick Inventory of Depressive Symptoms (QIDS-SR). Further treatment strategy is determined on the basis of these results: * If the patient has achieved remission (QIDS-SR < 6), BLT has been successful and the patient can continue with PE and IMCT. * If there is insufficient or no response (QIDS-SR of 6 or higher), BLT is extended with five more sessions the following week. * If necessary, a third week is optional. Week 2-4: Psycho Education will follow, 1 session. Week 3/4-9/10: ImCT will follow, 6 sessions. | Behavioural | Psycho-education and Imagery Focused Cognitive Therapy (in addition to Bright Light Therapy) |
| Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive TherapyWeek 1-3: blue-light blocking glasses will be administered. Week 2-4: Psycho Education will follow, 1 session. Week 3/4-9/10: ImCT will follow, 6 sessions. | Behavioural | Psycho-education and Imagery Focused Cognitive Therapy (in addition to Bright Light Therapy) |
| Psycho-education + Imagery focused Cognitive TherapyWeek 1: Psycho Education, 1 session. Week 2-7: ImCT will follow, 6 sessions. | Behavioural | Psycho-education and Imagery Focused Cognitive Therapy (in addition to Bright Light Therapy) |
Primary outcome
Change in depressive symptom scores on the IDS-SR
Time frame: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Significant lowering of IDS-SR questionnaire scores
Change in hyperactive symptom scores on the ASRM
Time frame: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Significant lowering of ASRM questionnaire scores
Change in anxiety symptom scores on the BAI
Time frame: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Significant lowering of BAI questionnaire scores
Change in sleep quality subjective rating on 11-point Likert scale
Time frame: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Significant improvement in subjective rating of sleep quality questionnaires
Change in activity levels subjective rating on 11-point Likert scale
Time frame: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up
Changes in daily and pre-post intervention self-report measurement of activity levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 41572055Treffers E, Snaphaan L, van den Berg KC, Bongers IMB. A study protocol for the feasibility and acceptability of a personalized early intervention combining light therapy, lifestyle psychoeducation, and imagery-focused cognitive therapy in individuals at risk for bipolar disorder. Int J Bipolar Disord. 2026 Jan 22;14(1):8. doi: 10.1186/s40345-026-00410-4.
- Individual participant dataSharing planned: Yes. The raw data is generated at the research location and is not shared with other researchers working elsewhere. After publication of the results, only data without privacy sensitive information and without study specific codes (fully anonymous), that support the findings are available from GGzE upon reasonable request (both in and outside the European Union). Before sharing this anonymous data, GGzE carefully investigates this request in consideration of the Dutch AVG and UAVG (Dutch Act on Implementation of the General Data Protection Regulation).
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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.
Liselore Snaphaan, PhD contact
Inge Bongers, Prof. Dr. principal investigator
GGzE, Tilburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy, Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy and Psycho-education + Imagery focused Cognitive Therapy in people with Bipolar Disorder and Mood Swing, run by Geestelijke Gezondheidszorg Eindhoven (GGzE) at 1 site in Netherlands.
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 6 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Else Treffers, MSc (+31622559192, else.treffers@ggze.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptom scores on the IDS-SR (time frame: at baseline; 3 x per day during whole study (up to 7 weeks); immediately after intervention; and at 3 months follow-up). 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?
On the ClinicalTrials.gov record for NCT06282250, which also lists 1 linked publication.
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 11 Apr 2024.