NCT06215235

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 18, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

September 8, 2023

Last Update Submit

September 22, 2025

Conditions

Depressive Symptoms

Keywords

Depressive symptomsBright light therapyImplementationIntellectual disability

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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)

    three times during study, 3-4 months in between

Secondary Outcomes (2)

  • Depressive symptoms

    1 year

  • Behaviour

    1 year

Study Arms (1)

Persons involved in BLT

Persons with ID and staff who are involved in BLT. Either by receiving BLT, or by prescribing or facitating BLT.

Other: Bright light therapy

Interventions

Bright light therapyOTHER

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

Persons involved in BLT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)
  • years or older
  • informed consent

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ErasmusMC

Rotterdam, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

DepressionIntellectual Disability

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator Quality

Study Record Dates

First Submitted

September 8, 2023

First Posted

January 22, 2024

Study Start

October 18, 2023

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

NL(1)