Time to Step Up to Stepped Care: A Novel Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain

NARecruitingINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

March 31, 2027

Study Completion Date

September 30, 2027

Conditions
Chronic Spinal Pain
Interventions
BEHAVIORAL

Standard Care CBTi

Standard Care CBTi will take 10 weeks, during which the participant will receive 5 online les-sons and 3 online face-to-face talks with the therapist. The construction of the online intervention was based on self-help materials, research of the literature, and patient interviews. It consists of 5 online les-sons and incorporates elements commonly used in face-to-face CBTi. The 5 online lessons, one introduced every second week, cover the following topics: Education, stimulus control, sleep restriction, relaxation, cognitions. The intervention is supported by online coaching, with feedback aimed at reviewing exercis-es, clarifying information, and motivating patients to continue the course and make necessary behavioral changes.

BEHAVIORAL

Stepped Care CBTi

"The stepped care approach in CBTi entails a two-step approach. Participants in this group all receive an initial entry level session of 1 hour delivered by a trained physiotherapist. Step 1: The entry level in this stepped care approach will imply a single, 1-hour long session, administered by a physiotherapist. This single session will cover: 1) education on sleep, sleep pressure, circadian rhythms; 2) introducing entry-level CBT-i principles (e.g., optimizing sleep environment, pre-bedtime food and beverage consumption) 3) pinpointing 2 to 3 of the most relevant strategies for the participant; and 4) creating an action plan for consistent implementation of these strategies over the next month. One month after 'Step 1' the participants' score on the Insomnia Severity Index (T1) will guide further decision making. Those with ISI scores \<12 will enter the follow-up phase immediately. Those with ISI scores ≥12 after step 1 will be referred to standard care CBTi."

Trial Locations (1)

1090

RECRUITING

Vrije Universiteit Brussel, Brussels

All Listed Sponsors
lead

Vrije Universiteit Brussel

OTHER