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NCT Number: NCT06215235

Implementation of Bright Light Therapy ID

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ErasmusMC

Rotterdam, 3015 GD, Netherlands

Location status: Recruiting

Location contact

Marieke Wouters, PhD

PRINCIPAL_INVESTIGATOR

Mylène Bohmer, PhD

CONTACT

[email protected]

+31107030004

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • n/a

Treatment and study plan

Bright Light Therapy

Other

for 2 weeks the patient will take place for a 10.000lux lamp for 20-30 minutes.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

Secondary outcomes

  1. Depressive symptoms

    Time frame: 1 year

    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.

  2. Behaviour

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Alleviation of Depressive Symptoms in People With Intellectual Disabilities

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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