NCT06633263Enrolling by invitation
Combined Effect of TCC-I and BATD on Depressive Symptoms and Insomnia
Combined Effect of Cognitive Behavioral Therapy for Insomnia and a Behavioral Activation Program for Depression on Depressive Symptoms and Insomnia : A Multiple Case Study
Source: ClinicalTrials.gov · Last updated 1 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goals of this interventional study is to study if the combine effects of Behavioral Activation Treatment for Depression (BATD) and Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective on primary outcomes : depression, insomnia, well-being and anxiety and secondary outcomes : worry, rumination, behavioral inertia, experiential avoidance, anticipatory pleasure deficits, cognitive resource deficits, emotional reactivity, quality of sleep, and sleep beliefs for participants suffering from depression and insomnia disorders.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 2 Oct 2024
- Start date
- 21 Oct 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University of Liege
- Diseases
- Depression
- NCT number
- NCT06633263
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 21 Oct 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have recently received or are currently receiving other interventions that could be confused with our intervention, such as those undergoing treatment for sleep or depression, or those undergoing parallel psychological or pharmacological treatment (antidepressants and anxiolytics will be accepted provided they have been stabilized for at least two months and there are no planned changes in the following weeks).
Other illness
- Participants requiring different treatment, i.e. those with symptoms suggestive of psychotic disorder, bipolar disorder, substance abuse disorder, excessive suicidal ideation, or other sleep pathology (such as sleep apnea, restless legs syndrome, narcolepsy, sleepwalking, or periodic limb movements)
Other
- Participants with commitments that disrupt nocturnal sleep cycles and habits, such as those who no longer work or who work night shifts, will also be excluded from the study.
Who the study is looking for
- Participants will be adults with depression (PhQ 9 \> 10; cut-off for moderate depression) and insomnia (Insomnia Severity Index \> 11) who also meet DSM-V criteria for depression and insomnia (APA, 2013) and have a good understanding of French.
Age in the registry: 18 years to 67 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CPLU (clinique psychologique et logopédique de l université de Liège) Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.