| Recruitment/screening | Baseline assessment | Visit 1 | Monitoring calls | Post-intervention follow-up assessment | Post-intervention follow-up assessment | 6 Month post-intervention follow-up assessment | Early termination |
---|---|---|---|---|---|---|---|---|
Time-point (Week) | - 4 | 1 | 3 | 4 and 8 | 12 | 14 | 36 | Â |
Assessments | ||||||||
Informed consent | X | X | Â | Â | Â | Â | Â | Â |
Inclusion/exclusion criteria | X | X | Â | Â | Â | Â | Â | Â |
Self report measures | Â | X | Â | X | X | Â | X | Â |
Sleep diary | Â | X | Â | Â | X | Â | X | Â |
Actigraphy | Â | X | Â | Â | X | Â | Â | Â |
Psychiatric assessment | Â | X | Â | Â | X | Â | Â | X |
Medical check-up* | Â | X | X | Â | X | Â | Â | Â |
Monitor for suicidality* | Â | X | X | Â | X | Â | Â | X |
Adverse events* | Â | Â | X | Â | X | Â | Â | X |
Forms/measures | ||||||||
Depression (QIDS) | X | Â | Â | Â | Â | Â | Â | Â |
Restless legs (RLS) | X | Â | Â | Â | Â | Â | Â | Â |
Insomnia (ISI) | X | X | Â | X | X | Â | X | Â |
Obstructive sleep apnea (Berlin questionnaire) | X | Â | Â | Â | Â | Â | Â | Â |
Psychiatric diagnosis (SCID) | Â | X | Â | Â | X | Â | Â | Â |
Global functioning (GAF) | Â | X | Â | Â | X | Â | Â | Â |
Depression (HAM-D) | Â | X | X | Â | X | Â | Â | Â |
Anxiety (HAM-A) | Â | X | Â | Â | X | Â | Â | Â |
Disease burden (CIRS-G) | Â | X | Â | Â | Â | Â | Â | Â |
Social and occupational functioning (SOFAS) | Â | X | Â | Â | X | Â | Â | Â |
Cognition (MMSE) | Â | X | Â | Â | Â | Â | Â | Â |
Depression (CES-D) | Â | X | Â | X | X | Â | X | Â |
Anxiety (STPI) | Â | X | Â | Â | X | Â | X | Â |
Sleep (DBAS) | Â | X | Â | Â | X | Â | X | Â |
Sleep (MEQ) | Â | X | Â | Â | Â | Â | Â | Â |
Health and wellbeing (SF-12) | Â | X | Â | Â | X | Â | X | Â |
Alcohol use (AUDIT) | Â | X | Â | Â | X | Â | X | Â |
Physical activity | Â | X | Â | Â | X | Â | X | Â |
Personality (Locus of control) | Â | X | Â | Â | Â | Â | Â | Â |
Program evaluation | Â | Â | Â | Â | X | Â | Â | Â |