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The effect of light therapy on depression in adults with intellectual disabilities.

The effects of bright light therapy for depression in adults with intellectual disabilities.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24095
Enrollment
219
Registered
2015-04-13
Start date
2015-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The primary outcome is depressive symptoms. Depressive symptoms will be primarily studied, because diagnosing a major depressive disorder is not always possible in people with intellectual disabilities due to diagnostic difficulties related to their limited cognitive abilities. Secondary outcome measures are major depression, circadian rhythm and stress.

Interventions

Participants will be randomly divided into three groups: - Group I: this group will receive two weeks of morning light therapy (30 min with 20 cm distance or 60 min with 30 cm distance) with a 10.000

Sponsors

Erasmus MC, University Medical Center Rotterdam Ipse de Bruggen, Zwammerdam Amarant Groep, Tilburg Abrona, Huis ter Heide
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Minimal age of 18 years - Intellectual disability (IQ ¡Ü 70) - Informed consent - Major depression or observable symptoms of depression

Exclusion criteria

Exclusion criteria: - Bipolar disorder type 1 or type 2 - When the diagnosis dementia is made by a physician or behavioural scientist/psychologist - If there is suicidal behaviour or currently suicidal expressions. - When an individual has or has had a hypomanic episode, manic episode of psychotic episode. - When there is or has been a prepartum and/or postpartum depression. - If the participant has a delirium. - When the lens of the eye is missing (aphakia).

Design outcomes

Primary

MeasureTime frame
The primary outcome measure in this study is the severity of depressive symptoms as measured with the depressive mood subscale of the Dutch version of the Anxiety, Depression And Mood Scale (ADAMS). The depressive symptoms of participants in both light therapy groups are compared with the depressive symptoms of participants who don’t get light therapy (care as usual group) immediately after the two week period of light therapy and four weeks after light therapy (follow-up). The ADAMS has to be completed by a professional caregiver.

Secondary

MeasureTime frame
Secondary outcomes are whether there is a significantly different effect on depressive symptoms as measured with the depressive mood subscale of the ADAMS of both light devices (10.000 lux versus 100-499 lux) immediately after the two week period of light therapy and four weeks after light therapy. The presence of major depressive disorder according to the DSM-IV criteria will be studied using the Dutch version of the PAS-ADD Clinical Interview before the start of light therapy and afterwards in participants with a prior diagnosis of major depression. (PAS-ADD: Psychiatric Assessment Schedule for Adults with Developmental Disability). Depressive symptoms will be further investigated using two other additional scales for depressive symptoms: the signalizing depression list and the Aberrant behavior checklist, which both have to be completed by a professional caregiver. Next to depressive symptoms, the effect of light therapy on circadian rhythm and stress will be studied. Circadian rhythm will be studied by studying the sleep-wake pattern and measuring the melatonin curve. Stress will be studied by investigating cortical level is hair samples. Also, the expectations concerning the effect of light therapy of the participant or their professional caregiver will be collected prior to the light therapy using a questionnaire and the compliance to light therapy will be collected daily during the two week period of light therapy using a log. The amount of life events in the year prior to the enrolment in the study will be completed by the professional caregiver. Life events are related to depression and to stress. Personal (level of intellectual disability, presence of psychiatric disorders, physical medical conditions) and environmental characteristics will be retrieved from participants’ medical en psychological files.

Contacts

Public ContactPauline Hamers

Wytemaweg 80

p.hamers@erasmusmc.nl06-51861657

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)