The SMILE study:Sleep Mood lntervention: Live Effectivelya group intervention in students with sleep problems

Recruiting

• Conditions: slaap; stemming; Sleep; mood; negative thoughts

• Registration Number: NL-OMON24628
• Lead Sponsor: eiden University (Clinical Psychology)Leiden Treatment and Expertise Center (Leiden Universitair Behandeling en Expertise Centrum)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1.Self-reported sleep complaints (ISI score of >=10).

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

6.No self-reported severe sleep complaints (ISI score of <10 ).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Insomnia Severity Index<br /><br>2. Subjective sleep quality (as assessed with a sleep diary).

Secondary Outcome Measures

Name	Time	Method
1. Objective sleep quality and quantity (as assessed with actigraphy); outcomes typically involve sleep efficiency, total sleep time, sleep onset latency and wake time after sleep onset.<br /><br>2. Self-reported depressive symptoms (Beck Depression Inventory, BDI)<br /><br>3. Self-reported anxiety symptoms (Hospital Anxiety and Depression scale – Anxiety Subscale, HADS-A) <br /><br>4. Self-reported quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form, Q-LES-G-SF)<br><br /><br /><br>6.1.3Other study parameters (if applicable)<br /><br><br>Covariates: Demographic characteristics (age, gender), ethnicity, medication use, alcohol use, smoking, relationship status, children in household will be assessed at baseline via online questions. <br /><br /><br><br>Mediators: Ecological Momentary Assessments (positive /negative affect, alertness and fatigue). Online questionnaires: Dysfunctional Beliefs and Attitudes about Sleep (DBAS) and Pre-Sleep Arousal Scale (PSAS). <br><br>