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

NCT06771856 | Recruiting DMC

• 2 other identifiers: 24408_StepUpStudy1251225N
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic spinal pain (i.e., chronic neck pain and chronic low back pain) are highly prevalent, and are known for their immens personal and socio-economic burden. Chronic spinal pain is impacted by many aspects, and in this story, insomnia plays an important role. Clinical insomnia symptoms are very common in people suffering from chronic spinal pain, and the presence of insomnia is known to aggravate the chronic spinal pain symptoms. While research shows that tackling insomnia in these patients is helpful for these patients, the availability of cognitive behavioral therapy, the golden standard to treat insomnia, is unfortunately extremely limited. Therefore this study aims to investigate whether a stepped care approach to cognitive behavioral therapy is a solution to this problem.

Conditions

Chronic Spinal Pain

Keywords

insomnia; stepped care; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Rate of remission from insomnia

  Rate of insomnia remission will be assessed using the Insomnia Severity Index (ISI), a self-report questionnaire assessing the nature, severity, and impact of insomnia. Participants will be considered treatment responders if their Insomnia Severity Index (ISI) score improves by ≥8 points and will be considered as having remitted if their post-treatment ISI score is \<12.

  6 months post-treatment

Secondary Outcomes (12)

• Insomnia Severity

  Change from baseline to directly post-treatment, 6 months and 12 months follow-up

• Medical Consumption Questionnaire

  At baseline, 6 months follow-up and 12 months follow-up.

• Productivity Cost Questionnaire

  At baseline, 6 months follow-up and 12 months follow-up.

• Health-related quality of life

  At baseline, 6 months follow-up and 12 months follow-up.

• Sleep quality

  At baseline, directly post-treatment, at 6 months follow-up and at 12 months follow-up

Other Outcomes (2)

• Demographics

  Baseline

• Adverse Events

  Directly post-treatment, at 6 months follow-up and at 12 months follow-up

Study Arms (3)

Stepped Care CBTi

EXPERIMENTAL

Stepped Care Cognitive Behavioral Therapy for Insomnia (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. Whether or not they are afterwards referred to the second step (standard care CBTi) depends on their remission status.

Behavioral: Standard Care CBTi; Behavioral: Stepped Care CBTi

Standard Care CBTi

ACTIVE COMPARATOR

Standard Care CBTi will take 10 weeks, during which the participant will have access to an online platform and will have and 2 online face-to-face talks with a certified psychologist. For the online lessons, a validated and effective online intervention will be used. The construction of this online intervention was based on self-help materials, research of the literature, and pa-tient interviews. Standard Care CBTi consists of weekly online webinars and/or exercises and incorporates elements commonly used in face-to-face CBTi. The 10-week program covers the follow-ing topics: the sleep-wake system, how sleep problems arise, bed restriction, reprogram the internal clock, daily habits, stress system, etc. The intervention is supported by online coaching: at two specific time points (around week 3 and week 8) the therapist and participant will have a face-to-face online meeting.

Behavioral: Standard Care CBTi

Usual Care group

NO INTERVENTION

In the usual care group, participants will be asked to continue as usual regarding their sleep behavior and pain-related medical use. They can follow regular care for their pain- and/or sleep problem as recommended by their general practitioner. Their medical use and behavior will be monitored. Once data collection has ended in a usual care participant (i.e., at 12 months follow-up), they are offered a Standard Care CBTi intervention.

Interventions

Standard Care CBTi BEHAVIORAL

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.

Standard Care CBTi; Stepped Care CBTi

Stepped Care CBTi BEHAVIORAL

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.

Stepped Care CBTi

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Insomniacs (18-65y/o), with an Insomnia Severity Index score ≥15 (i.e., at least moderate insomnia) suffering from CSP, defined as non-specific spinal pain of at least 3 month's duration, currently seeking care for CSP, with a pain severity of ≥3/10 on the Brief Pain Inventory are recruited. In the absence of other intrin-sic sleep disorders and shift work, insomnia is defined as \>30 minutes sleep latency and/or minutes awake after sleep onset for \>3 days/week for \>3 months.

You may not qualify if:

• Having severe underlying sleep pathology, being pregnant or given birth in the preceding year, suffering from a chronic condition which is currently causing other pain complaints, or suffering from severe psychological or psychiatric dis-eases, dementia or cognitive impairment. Eligible participants are asked not to start new treatments or medication, and continuing the usual non-physical thera-py care (6 weeks prior to and during study participation to obtain a steady state). A sleep-related anamnesis and a polysomnography assessment are performed to determine and exclude severe underlying comorbid sleep disorders.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Anneleen Malfliet, PhD

CONTACT

003224774531; StepUpStudy@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Postdoctoral Researcher

Model Details: To examine the research aims, a three-arm RCT in people with CSP will be used to compare stepped care CBT-i, standard CBT-i, and a usual group.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)