Implementation of Bright Light Therapy ID

Depressive Symptoms Clinical Trial

Official title:

Alleviation of Depressive Symptoms in People With Intellectual Disabilities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215235
• Other study ID #: Panama-10390
• Secondary ID: Wouters
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Intellectual Disability

Intervention

Other:
• Bright light therapy
for 2 weeks the patient will take place for a 10.000lux lamp for 20-30 minutes.

Locations

Country	Name	City	State
Netherlands	ErasmusMC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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