Implementation of Bright Light Therapy ID

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Symptoms
• Intervention / Treatment: Other: Bright light therapy

• Study Type: Observational
• Enrollment (Estimated): 105

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Recruiting
    • ErasmusMC
    • Principal Investigator: Marieke Wouters, PhD
    • Contact: Mylène Bohmer, PhD; Phone Number: +31107030004; Email: m.bohmer@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; for 2 weeks the patient will take place for a 10.000lux lamp for 20-30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Implementation; Depressive symptoms; Intellectual disability; Bright light therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Depression; Intellectual Disability; Therapeutics; Phototherapy; Ultraviolet Therapy
• Other Study ID Numbers: Panama-10390; Wouters (Other Identifier: Erasmus MC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No