NCT03075683

Brief Summary

The main goal is to study the effect of therapist-guided internet-delivered cognitive behavioural therapy for insomni comorbid with chronic pain in a clinical sample.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

March 2, 2017

Last Update Submit

May 7, 2020

Conditions

Chronic InsomniaChronic Pain

Keywords

Cognitive behavioural therapyNon-pharmacological treatmentInternet mediated

Outcome Measures

Primary Outcomes (1)

  • Insomnia Severity Index

    A well-used, valid and reliable self-report questionnaire with seven items concerning subjective symptoms and consequences of insomnia ranging from 0 to 28 points.

    8 weeks

Secondary Outcomes (2)

  • Sleep latency

    8 weeks

  • Wake time after sleep onset

    8 weeks

Study Arms (2)

Cognitive behavioural therapy

EXPERIMENTAL

Internet-based cognitive behavioural therapy for insomnia

Behavioral: Cognitive behavioural therapy

Applied relaxation

ACTIVE COMPARATOR

Internet-based applied relaxation

Behavioral: Applied relaxation

Interventions

Cognitive behavioural therapyBEHAVIORAL

Eight sessions of internet-based CBT for insomnia comorbid with chronic pain, with active therapist support.

Cognitive behavioural therapy
Applied relaxationBEHAVIORAL

Eight sessions of internet-based applied relaxation for insomnia comorbid with chronic pain, with active therapist support.

Applied relaxation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic insomnia Chronic benign pain No or stable pharmacological treatment for insomnia and or pain

You may not qualify if:

  • Participation in pain management programme Pregnancy Shift work Untreated medical or psychiatric disease or disorder that could be negatively affected by insomnia treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala university hospital

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersChronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kristoffer Bothelius, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 9, 2017

Study Start

February 1, 2017

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)