ClinicalTrials.gg
CompletedNCT03316846TIPPSUpdated May 27, 2020

Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress

An interventional study of Internet-Delivered Cognitive Behavioral Therapy in Chronic Pain, Depressive Symptoms and Anxiety, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by Uppsala University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2016, registered Sep 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
187
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Chronic Pain by Uppsala University — 3 open to participants now, 3 under way, none of them phase 3. Chronic Pain · Uppsala University.

Started
2016
the only one that year
No phase
8 of 15
1 open now
Registered
3rd of 15
by date

Among the 15 studies in Chronic Pain by Uppsala University, this one is the only one that started in 2016, is one of 8 with no phase, and was the 3rd registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

3 of the 15 studies in Chronic Pain by Uppsala University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 16 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Chronic Pain by Uppsala University, or all of them as a file.
02

Study summary

This study is a randomized controlled trial studying the efficacy of an iCBT treatment for patients with chronic pain and comorbid psychiatric distress. Half the participants will receive treatment at first, while the other half serve as a control group. After the first group has received treatment, the same program will be offered to participants in the control group. Treatment will be tailored on the level of individual participants, enabling individuals suffering a wide range of problems to be recruited. The treatment will consist of a 10-week guided self-help program, followed by a booster program and follow-up one year later. During the curse of the treatment the participants will be guided via text communication by a licensed psychologist or a candidate psychologist on their last year of studies.

The primary hypothesis is that an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric distress. The investigators expect that patients in the treatment group will show reduced levels of disability, depression and anxiety, while improving on scales measuring coping and quality of life.

Read the detailed description

Patients suffering from chronic pain often experience comorbid psychiatric distress. Cognitive behavioral therapy (CBT) has been shown to be effective in treating both these problems. However delivering relevant treatment can be difficult due to logistics, cost and lack of personnel with required competence. Delivering CBT though the internet (iCBT) is a novel approach, sidestepping logistical issues while lowering costs. This however, is an area were research is lacking, and though there are several studies showing iCBT to be efficacious in treating both pain and psychiatric conditions, research on a combined approach is scarce.

This study will primarily investigate whether an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric conditions. The project will also clarify whether a following booster-program, also administered tough the internet, is helpful in maintaining and increasing effects of the initial treatment. Lastly, analysis of possible mediating variables will be able to give insight into the internal workings of the treatment itself, further elucidating efficacy of specific interventions, data which will be useful in future developments of treatment design.

The treatment will be based on a previously developed program, devised to target depression and anxiety in patients with chronic pain. The treatment will consist of a 10-week period where participants would get access to a series of treatment modules, each addressing a separate problem area using CBT techniques. The treatment includes modules addressing depression, anxiety, panic, worry, insomnia, stress, trauma, communication skills, and relaxation. The booster program will be based on the initial treatment, but will shorter, focusing on repetition, strategies for maintenance, and coping with setbacks. The platform used is an existing platform employed by Smärtcentrum at Uppsala university hospital for delivering internet based treatments.

The study will be conducted using a randomized controlled trial with a between-group design. Participants will be randomized to two groups, were one group will gain access to iCBT treatment while the second group will be a wait-list control, and will gain access to the program once treatment of the active group is finished. Participants will assessed by a licensed psychologist, and treatment modules assigned based on their individual needs. In addition to online CBT modules, consisting of information, exercises and homework assignments, all participants will have regular contact by secure email-channel with a licensed psychologist or last-year psychology student under supervision. This contact will guide treatment, providing support, feedback on homework, and if necessary clarify treatment content and help with IT-related problems interfering with treatment adherence. After a year, participants will be invited to take part in a follow-up module, consisting of limited treatment recapitulation and evaluation.

03

Conditions studied

  • Chronic Pain
  • Depressive Symptoms
  • Anxiety
  • Stress, Psychological

Keywords

  • Chronic Pain
  • Depression
  • Anxiety
  • Stress
  • iCBT
  • Cognitive behavioral therapy
  • Internet delivered
  • Tailored treatment
04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Experienced pain for at least the three previous months
  • Medically evaluated regarding the pain condition
  • Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
  • Access to, and ability to use, a personal computer with internet access
  • Mastery of the swedish language

Exclusion criteria

Exclusion Criteria:

  • Currently undergoing or planning to undergo CBT-treatment during the course of the study
  • Currently undergoing or planning to undergo major changes in pharmacotherapy during the course of the study, or have made such changes in the last 2 months
  • Have planned surgical intervention during the course of the study
  • Currently experiencing symptoms of severe depression (scores >16 on suicidality on M.I.N.I.)
  • Currently experiencing significant symptoms of psychosis (fulfills M.I.N.I criteria for psychotic syndrome, current)
  • Currently experiencing significant symptoms of alcohol or substance abuse (fulfills M.I.N.I criteria for alcohol- or substance use disorder)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
187 participants (actual)

Study arms

  • Experimental
    Internet-delivered therapy

    10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.

    Behavioral: Internet-Delivered Cognitive Behavioral Therapy

  • No intervention
    Wait list control group

    Wait list control group, receives treatment at later point.

Interventions

  • BehavioralInternet-Delivered Cognitive Behavioral Therapy
06

What researchers measure

Primary outcomes

  1. Change from baseline in depressive symptoms

    Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items

    Time frame: at 10 weeks

  2. Change from baseline in depressive symptoms

    Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items

    Time frame: at one-year

  3. Change from baseline in psychosocial consequences of pain

    Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items

    Time frame: at 10 weeks

  4. Change from baseline in psychosocial consequences of pain

    Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items

    Time frame: at one-year

Secondary outcomes

  1. Change from baseline in anxiety sensitivity

    Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items

    Time frame: at 10 weeks

  2. Change from baseline in anxiety sensitivity

    Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items

    Time frame: at one-year

  3. Change from baseline in symptoms of depression and anxiety

    Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items

    Time frame: at 10 weeks

  4. Change from baseline in symptoms of depression and anxiety

    Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items

    Time frame: at one-year

  5. Change from baseline in pain disability

    Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items

    Time frame: at 10 weeks

  6. Change from baseline in pain disability

    Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items

    Time frame: at one-year

  7. Change from baseline in quality of life

    Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items

    Time frame: at 10 weeks

  8. Change from baseline in quality of life

    Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items

    Time frame: at one-year

  9. Fear of pain due to movement

    Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items

    Time frame: Baseline only

  10. Change from baseline in insomnia symptoms

    Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version

    Time frame: at 10 weeks

  11. Change from baseline in insomnia symptoms

    Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version

    Time frame: at one-year

  12. Change from baseline in PTSD symptoms

    Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version

    Time frame: at 10 weeks

  13. Change from baseline in PTSD symptoms

    Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version

    Time frame: at one-year

  14. Change from baseline in stress

    Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version

    Time frame: at 10 weeks

  15. Change from baseline in stress

    Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version

    Time frame: at one-year

  16. Change from baseline in GAD-symptoms

    Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version

    Time frame: at 10 weeks

  17. Change from baseline in GAD-symptoms

    Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version

    Time frame: at one-year

  18. Change from baseline in pain catastrophizing

    Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version

    Time frame: at 5 weeks

  19. Change from baseline in pain catastrophizing

    Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version

    Time frame: at 10 weeks

  20. Change from baseline in pain catastrophizing

    Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version

    Time frame: at one-year

  21. Change from baseline in coping strategies

    Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version

    Time frame: at one-year

  22. Change from baseline in coping strategies

    Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version

    Time frame: at 5 weeks

  23. Change from baseline in coping strategies

    Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version

    Time frame: at 10 weeks

  24. Change from baseline in pain acceptance

    Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version

    Time frame: at 5 weeks

  25. Change from baseline in pain acceptance

    Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version

    Time frame: at 10 weeks

  26. Change from baseline in pain acceptance

    Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version

    Time frame: at one-year

  27. Change from baseline in self efficacy

    Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version

    Time frame: at 5 weeks

  28. Change from baseline in self efficacy

    Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version

    Time frame: at 10 weeks

  29. Change from baseline in self efficacy

    Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version

    Time frame: at one-year

  30. Treatment credibility rating

    Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version

    Time frame: Baseline only

07

Study locations

1 site
  • Department of Psychology, Uppsala University
    Uppsala, Uppland 75236, Sweden
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in May 2017, 8 months.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 8 months is below that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2017
First posted
Oct 20, 2017
StartActual
Sep 13, 2016
Primary completionActual
May 2017
CompletionActual
Dec 2018
Last update
May 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03316846
Lead sponsor
Uppsala University
Collaborators
Uppsala University Hospital
Responsible party
Sponsor
First posted
Oct 20, 2017
Start date
Sep 13, 2016
Primary completion
May 2017
Completion
Dec 2018
Last update
May 27, 2020

Study contacts

Monica Buhrman, PhD
study director · Uppsala University
Gerhard Andersson, Professor
study chair · Linkoeping University
Torsten Gordh, Professor
study chair · Uppsala University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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