Can Cognitive Behavioral Therapy (CBT)-Insomnia be enhanced with clinical-grade, at-home sleep monitoring?: A Pilot study

Not Applicable

Recruiting

• Conditions: Insomnia; Mental Health - Other mental health disorders

• Registration Number: ACTRN12624000637549
• Lead Sponsor: Compumedics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-16
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Prospective participants will need to be aged 18-65, be available to attend four to eight, weekly (or fortnightly) therapy sessions, and have an Insomnia Severity Index (ISI) score of 10 or above.

Exclusion Criteria

The exclusion criteria are:
(i) any co-morbid pre-diagnosed, non-treated sleep disorder (e.g.,
obstructive sleep apnoea, sleep-wake cycle disorders);
(ii) the regular (3+nights per week) use of sleep
related medication;
(iii) any CBT-based treatment for insomnia in the previous 12-month period;
(iv) women who are pregnant, breastfeeding or parents with infants who need to need caregive overnight;
(v) any condition that is likely to impair the ability to participate in the treatment/study (e.g., severe mood difficulties; psychoses; neurological conditions; medical conditions requiring nursing care at night; alcohol/substance dependence; previous reaction to skin preparation, tapes and electrode gels used during PSG) ;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Symptom Severity[Insomnia Severity Index Immediately post treatment is the primary timepoint. This is between 0-7 days following the final CBT-Insomnia session.<br>ISI will be measured at baseline, post treatment and follow-up (3 months following the final CBT-Insomnia session).]

Secondary Outcome Measures

Name	Time	Method
Clinician experience survey[Bespoke clinician experience survey created for this study On completion of treatment delivery by each clinician (post treatment) 0-7 days following the final treatment session.];Client experience survey[Survey developed for this study Immediately post treatment (0-7 days after the final treatment session)];Fatigue symptoms[Fatigue Assessment Scale Immediately post treatment (0-7 days after the final treatment session)];Mood, anxiety and stress symptoms as assessed by the Depression Anxiety Stress Scale composite score.[Depression Anxiety Stress Scales Post treatment (0-7 days following the final treatment session)]