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App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Musculoskeletal Complaints

Primary Purpose

Insomnia, Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Digital Cognitive-behavioral therapy for insomnia (dCBT-I)
Usual care
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Taking part in inpatient rehabilitation due to long-term musculoskeletal complaints
  • Insomnia Severity Index (ISI) score >11.

Exclusion Criteria:

  • Not having a smartphone or tablet.
  • Individuals with work schedules that includes night shifts during the intervention
  • Pregnancy
  • Inadequate opportunity to sleep or living circumstances that prevent modification of sleep patterns such as having an infant
  • Currently receiving psychological treatment for insomnia
  • Medical history of contraindicating use of CBT-I such as epilepsy, recent cardiac surgery, and an attack phase of multiple sclerosis

Sites / Locations

  • Unicare HelsefortRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital Cognitive-behavioral therapy for insomnia (dCBT-I)

Usual care

Arm Description

In addition to the standard rehabilitation program, participants will receive the sleep intervention delivered via a smartphone app. We will use a Norwegian a program named Assistert Selvhjelp (In English: "Assisted Self-Help"). The app is fully automated and requires no contact with healthcare personnel. It can also be assessed on computers, but in the present project we will use the app-delivered version. It is based on the principles from face-to-face CBT-I including several modules consisting of sleep hygiene, stimulus control sleep restriction, cognitive therapy, and relaxation training. The modules also consist of learning material (e.g., quizzes and materials explaining and educating the patients about important sleep dimensions).

Participants randomized to usual care will receive the standard inpatient rehabilitation program. This is a traditional rehabilitation program consisting of physical activity, mindfulness excises, psychoeducation and acceptance and commitment therapy. One of the educational sessions is about sleep. Although this educational session overlaps with some of the content included in the intervention (e.g., sleep hygiene, stimulus control), it does not include any of the interactive features of the app.

Outcomes

Primary Outcome Measures

Insomnia
Degree of sleep problems measured by the insomnia severity index (ISI).

Secondary Outcome Measures

Insomnia
Degree of sleep problems measured by the insomnia severity index (ISI).
Health-related quality of life
Measured by the EuroQol EQ5D-5L questionnaire
Pain intensity
Scored from 0-100 on a visual analogue scale
Sick leave
Registry data from the National Insurance Administration (NAV).
Use of sleep and pain medications
Data from the national prescription registry
Physical function
Measured by the Patient-Specific Functional Scale (PSFS). Scored 0-10.
Fatigue
Scored from 0-100 on a visual analogue scale
Work ability
Measured by the work ability index single item (self- assessed work ability on a 0-10 scale)
Expectations about length of sick leave
Single item "What are the chances that you are back at work in 6 months?" on a 0-10 scale

Full Information

First Posted
October 5, 2022
Last Updated
August 28, 2023
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05572697
Brief Title
App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Musculoskeletal Complaints
Official Title
App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Comorbid Musculoskeletal Complaints and Insomnia Referred to 4-week Inpatient Multimodal Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this randomized clinical trial is to evaluate the effectiveness of app-delivered cognitive-behavioral therapy for insomnia adjunct to inpatient multimodal rehabilitation for individuals with comorbid insomnia and chronic pain, compared with rehabilitation (usual care) only.
Detailed Description
Insomnia is highly prevalent among patients receiving treatment for long-term musculoskeletal complains. Cognitive-behavioral therapy for insomnia (CBT-I) may be effective for improving sleep quality and pain-related outcomes in these patients, but the availability of this therapy is limited by few trained therapists. In this randomized clinical trial we will evaluate the effectiveness of app-delivered CBT-I adjunct to inpatients multimodal rehabilitation for individuals with comorbid insomnia and chronic pain, compared with rehabilitation (usual care) only. Patients referred to Unicare Helsefort (Norway) with long-term chronic musculoskeletal complains and insomnia are invited to the study. The rehabilitation program consists of 2+2 weeks of inpatient multimodal rehabilitation, where the patients are at home for two weeks between the rehabilitation stays. Participants in the intervention group will receive the (CBT-I) while participating in rehabilitation, while the control group will receive rehabilitation without the app (usual care). Based on sample size calculation recruiting 15 clusters with 2:1 randomization will achieve 80 % power to detect a 4-point difference between the intervention and usual treatment group on the insomnia severity index (ISI). Edit 25.08.23: We noted in the review process of a protocol paper that the description of our sample size calculation implied that 150 participants would be included in the study, rather than that 150 potential participants would be screened and that we anticipated that 5 from each group of the 15 clusters would be eligible (i.e. 75 included in the study). We have also revisited the sample size calculations to account for dropouts and low adherence rates known to be a problem in digital interventions. We expect a dropout rate of approximately 20 % and that around 50 % of the participants in the intervention group will complete at least four of the dCBT-I modules. Given that the per-protocol analysis is of particular interest in this study, we aim to recruit 21 clusters to account for the fact that we expect an average of four participants per cluster in the control group to complete the follow-up, and an average of two participants in the intervention group to complete at least four of the modules and attend the follow-up. As total sample size is hard to predict and the sample size is based on number of clusters we have not changed the total enrollment number.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized clinical trial with two parallel arms
Masking
None (Open Label)
Masking Description
Outcomes will be measured by registry data and questionnaires. Researchers will not have access to the randomization key before analyses are performed but blinding is not possible due to different number of participants in the two groups (as randomization is 2:1). The randomization procedure will be performed by the Clinical Research Unit (Klinforsk) at The Faculty of Medicine and Health Sciences at the Norwegian University of Science and Technology (NTNU) by use of a computer-generated block randomization. The randomization will be on group level to avoid contamination between participants in the same rehabilitation group.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital Cognitive-behavioral therapy for insomnia (dCBT-I)
Arm Type
Experimental
Arm Description
In addition to the standard rehabilitation program, participants will receive the sleep intervention delivered via a smartphone app. We will use a Norwegian a program named Assistert Selvhjelp (In English: "Assisted Self-Help"). The app is fully automated and requires no contact with healthcare personnel. It can also be assessed on computers, but in the present project we will use the app-delivered version. It is based on the principles from face-to-face CBT-I including several modules consisting of sleep hygiene, stimulus control sleep restriction, cognitive therapy, and relaxation training. The modules also consist of learning material (e.g., quizzes and materials explaining and educating the patients about important sleep dimensions).
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Participants randomized to usual care will receive the standard inpatient rehabilitation program. This is a traditional rehabilitation program consisting of physical activity, mindfulness excises, psychoeducation and acceptance and commitment therapy. One of the educational sessions is about sleep. Although this educational session overlaps with some of the content included in the intervention (e.g., sleep hygiene, stimulus control), it does not include any of the interactive features of the app.
Intervention Type
Behavioral
Intervention Name(s)
Digital Cognitive-behavioral therapy for insomnia (dCBT-I)
Intervention Description
6 week sleep intervention delivered via a smartphone app while taking part in inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.
Primary Outcome Measure Information:
Title
Insomnia
Description
Degree of sleep problems measured by the insomnia severity index (ISI).
Time Frame
3 months of follow-up
Secondary Outcome Measure Information:
Title
Insomnia
Description
Degree of sleep problems measured by the insomnia severity index (ISI).
Time Frame
6 and 12 months of follow-up
Title
Health-related quality of life
Description
Measured by the EuroQol EQ5D-5L questionnaire
Time Frame
3, 6 and 12 months of follow-up
Title
Pain intensity
Description
Scored from 0-100 on a visual analogue scale
Time Frame
3, 6 and 12 months of follow-up
Title
Sick leave
Description
Registry data from the National Insurance Administration (NAV).
Time Frame
12 months of follow-up
Title
Use of sleep and pain medications
Description
Data from the national prescription registry
Time Frame
12 months of follow-up
Title
Physical function
Description
Measured by the Patient-Specific Functional Scale (PSFS). Scored 0-10.
Time Frame
3, 6 and 12 months of follow-up
Title
Fatigue
Description
Scored from 0-100 on a visual analogue scale
Time Frame
3, 6 and 12 months of follow-up
Title
Work ability
Description
Measured by the work ability index single item (self- assessed work ability on a 0-10 scale)
Time Frame
3, 6 and 12 months of follow-up
Title
Expectations about length of sick leave
Description
Single item "What are the chances that you are back at work in 6 months?" on a 0-10 scale
Time Frame
3, 6 and 12 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Taking part in inpatient rehabilitation due to long-term musculoskeletal complaints Insomnia Severity Index (ISI) score >11. Exclusion Criteria: Not having a smartphone or tablet. Individuals with work schedules that includes night shifts during the intervention Pregnancy Inadequate opportunity to sleep or living circumstances that prevent modification of sleep patterns such as having an infant Currently receiving psychological treatment for insomnia Medical history of contraindicating use of CBT-I such as epilepsy, recent cardiac surgery, and an attack phase of multiple sclerosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lene Aasdahl, MD PhD
Phone
+47 93224342
Email
lene.aasdahl@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Eivind S Skarpsno, PhD
Phone
+4797521297
Email
eivind.s.skarpsno@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene Aasdahl
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Solveig K Grudt
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Unicare Helsefort
City
Rissa
State/Province
Hasselvika
ZIP/Postal Code
7112
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristian Lyng-Jørgensen
Phone
+47 40 00 60 50
Email
kristian.lyng.jorgensen@unicare.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Musculoskeletal Complaints

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