Depressive SymptomsNCT06215235
Implementation of Bright Light Therapy ID
An observational study of Depressive Symptoms, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Many adults with intellectual disabilities (ID) have depressive symptoms, which negatively impact their quality of life. A lot of of the non-medicinal forms of treatment are not or hardly suitable for people with ID. Bright light therapy (BLT) seems to be a good option. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Bright light therapy
- How many people
- 105 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Oct 2023to May 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients are adult with an intellectual disability who have received BLT for their depressive symptoms. * Staff are adults (without ID) who work for one of the two care organizations and who are involved in the implementation or prescription or facilitation of BLT.
Who may be able to join
- Involved in the implementation of BLT (staff) OR
- Involved in the prescription or application of BLT (staff/relatives) OR
- receiving BLT for their depressive symptoms (patients with ID)
- 18 years or older
- informed consent
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
ErasmusMC
Rotterdam, 3015 GD
Mylène Bohmer, PhD, +31107030004, m.bohmer@erasmusmc.nl
Marieke Wouters, PhD
About this study
Official title: Alleviation of Depressive Symptoms in People With Intellectual Disabilities
Many adults with intellectual disabilities (ID) have depressive symptoms, which negatively impact their quality of life. A lot of of the non-medicinal forms of treatment are not or hardly suitable for people with ID. Bright light therapy (BLT) seems to be a good option. Earlier research has shown that BLT is applicable in this group and seems promising in terms of reducing depressive symptoms, without serious side effects.
In part 1 of this project we investigate the implementation of BLT at Amarant. We will take the lessons learned into part 2 of this project: the implementation of BLT at Abrona. We will evaluate this process and the outcomes.
- Conditions
- Depressive Symptoms
- Being tested
- Bright light therapy
- Keywords
- Depressive symptoms, Bright light therapy, Implementation, Intellectual disability
- Medical subject headings
- Depression, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright light therapyOther
for 2 weeks the patient will take place for a 10.000lux lamp for 20-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Persons involved in BLT | Persons with ID and staff who are involved in BLT. Either by receiving BLT, or by prescribing or facitating BLT. Receives: Other: Bright light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability
Acceptability (Proctor et al., 2011) is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. This will be measured by interviews.
Measured: three times during study, 3-4 months in between
appropriateness
Appropriateness (Proctor et al., 2011) is the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. This will be measured by interviews.
Measured: three times during study, 3-4 months in between
feasibility of the intervention
Feasibility (Proctor et al., 2011) is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. This will be measured by interviews.
Measured: three times during study, 3-4 months in between
fidelity
Fidelity (Proctor et al., 2011) is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol or as it was intended by the program developers. This will be measured by interviews and by case report study.
Measured: three times during study, 3-4 months in between
strategies
Implementation strategies are methods to enhance the adoption, implementation and sustainability of a policy or intervention. This will be studied with interview data and logs.
Measured: three times during study, 3-4 months in between
Determinants
Barriers and facilitators to BLT, measured by interviews using the Consolidated Framework for Implementation Research (CFIR, Damschroder et al., 2009)
Measured: three times during study, 3-4 months in between
Secondary outcomes (2)
Depressive symptoms
Depressive symptoms measured by the Anxiety, Depression, and Mood Scale (ADAMS, Hermans et al., 2008). It contains 28 items, each can be scored 0 to 3. Minimum score 0 and maximum score 84 and higher scores mean worse outcome.
Measured: 1 year
Behaviour
Behaviour that could be linked to depressive symptoms measured by the Aberrant Behaviour Checklist (ABC, Aman et al., 1985). It contains 58 items, each can be scored 0 to 3. Minimum score 0 and maximum score 174. Higher score means worse outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start18 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margreet Vlastuin, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215235
- Sponsor's protocol ID
- Panama-10390
- Other IDs
- Wouters
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviation of Depressive Symptoms in People With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT06215235
- Acronym / sponsor ID
- Panama-10390
- Conditions
- Depressive Symptoms
- Keywords
- Depressive symptoms, Bright light therapy, Implementation, Intellectual disability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 22 Jan 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.
Many adults with intellectual disabilities (ID) have depressive symptoms, which negatively impact their quality of life. A lot of of the non-medicinal forms of treatment are not or hardly suitable for people with ID. Bright light therapy (BLT) seems to be a good option. Earlier research has shown that BLT is applicable in this group and seems promising in terms of reducing depressive symptoms, without serious side effects.
In part 1 of this project we investigate the implementation of BLT at Amarant. We will take the lessons learned into part 2 of this project: the implementation of BLT at Abrona. We will evaluate this process and the outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons involved in BLT | – | Other: Bright light therapyPersons with ID and staff who are involved in BLT. Either by receiving BLT, or by prescribing or facitating BLT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients are adult with an intellectual disability who have received BLT for their depressive symptoms. * Staff are adults (without ID) who work for one of the two care organizations and who are involved in the implementation or prescription or facilitation of BLT.
Key inclusion criteria (5 listed)
- Involved in the implementation of BLT (staff) OR
- Involved in the prescription or application of BLT (staff/relatives) OR
- receiving BLT for their depressive symptoms (patients with ID)
- 18 years or older
- informed consent
Key exclusion criteria (1 listed)
- n/a
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 therapyfor 2 weeks the patient will take place for a 10.000lux lamp for 20-30 minutes. | Other | Persons involved in BLT |
Primary outcome
acceptability
Time frame: three times during study, 3-4 months in between
Acceptability (Proctor et al., 2011) is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. This will be measured by interviews.
appropriateness
Time frame: three times during study, 3-4 months in between
Appropriateness (Proctor et al., 2011) is the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. This will be measured by interviews.
feasibility of the intervention
Time frame: three times during study, 3-4 months in between
Feasibility (Proctor et al., 2011) is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. This will be measured by interviews.
fidelity
Time frame: three times during study, 3-4 months in between
Fidelity (Proctor et al., 2011) is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol or as it was intended by the program developers. This will be measured by interviews and by case report study.
strategies
Time frame: three times during study, 3-4 months in between
Implementation strategies are methods to enhance the adoption, implementation and sustainability of a policy or intervention. This will be studied with interview data and logs.
Determinants
Time frame: three times during study, 3-4 months in between
Barriers and facilitators to BLT, measured by interviews using the Consolidated Framework for Implementation Research (CFIR, Damschroder et al., 2009)
2 secondary outcomes
Depressive symptoms
Time frame: 1 year
Behaviour
Time frame: 1 year
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 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Symptoms, run by Erasmus Medical Center 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 5 inclusion and 1 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 25 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acceptability (time frame: three times during study, 3-4 months in between). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.