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

The effects of bright light therapy for depression in adults with intellectual disability. - RCT Bright Light Therapie ID

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44100
Enrollment
171
Registered
2015-04-03
Start date
2015-08-17
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Verstandelijke beperking Depression sadness

Interventions

Each individual participant from the two light therapy groups (the group with the 10,000 lux light box and the group with the 100-499 lux light box) will receive bright light therapy (in the morning

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Minimal age of 18 years. - Intellectual disability (IQ*70). - Informed consent. - A depression or observable symptoms of depression.

Exclusion criteria

Exclusion criteria: - Bipolar disorder type 1 or type 2 (because the risk of the occurrence of a manic episode). - When the diagnosis 'dementia' is made **by a physician or behavioral scientist. - If there is suicidal behavior or currently suicidal expressions. - When an individual has or has had a hypomanic episode, manic episode or 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 Anxiety, Depression and Mood Scale (ADESS). 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).

Secondary

MeasureTime frame
Besides the primary study parameter we will also investigate whether there is a significantly larger effect when light therapy is given with lamp model 1 compared to lamp model 2. And we examine whether any observed effect of light therapy still exists after a period of 4 weeks (follow-up measurement). For these two secondary study parameters we will also use the Depressive mood subscale of the Anxiety, Depression and Mood Scale (ADESS). Any existing diagnosis of major depressive disorder according to the criteria of the DSM IV is made prior to the intervention. The researcher will (after extensive training) decline a diagnostic interview for all participants. We use the Dutch translation of the PAS-ADD (Psychiatric Assessment Schedule for Adults with Developmental Disability, Clinical Interview). Besides depressive symptoms we will also investigate the effect of lighttherapy on the circadian rhythm (Actiwatch and DLMO) and stress level (cortisol level), expectations of the caregiver (and, if possible, of the participant) over the effect of light therapy on depressive symptoms of the participant and the number of days the intervention is deployed (compliance). Personal and environmental characteristics will be retrieved from the participants' medical and psychological files and we investigate the number of life events of the participant in the past year.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)