Skip to main content
OpenTrials
Completed

NCT Number: NCT03316846

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, Uppsala University

Uppsala, Uppland, 75236, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Internet-delivered cognitive behavioral therapy

Behavioral

Primary outcomes

  1. Change from baseline in depressive symptoms

    Time frame: at 10 weeks

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

  2. Change from baseline in depressive symptoms

    Time frame: at one-year

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

  3. Change from baseline in psychosocial consequences of pain

    Time frame: at 10 weeks

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

  4. Change from baseline in psychosocial consequences of pain

    Time frame: at one-year

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

Secondary outcomes

  1. Change from baseline in anxiety sensitivity

    Time frame: at 10 weeks

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

  2. Change from baseline in anxiety sensitivity

    Time frame: at one-year

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

  3. Change from baseline in symptoms of depression and anxiety

    Time frame: at 10 weeks

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

  4. Change from baseline in symptoms of depression and anxiety

    Time frame: at one-year

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

  5. Change from baseline in pain disability

    Time frame: at 10 weeks

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

  6. Change from baseline in pain disability

    Time frame: at one-year

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

  7. Change from baseline in quality of life

    Time frame: at 10 weeks

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

  8. Change from baseline in quality of life

    Time frame: at one-year

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

  9. Fear of pain due to movement

    Time frame: Baseline only

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

  10. Change from baseline in insomnia symptoms

    Time frame: at 10 weeks

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

  11. Change from baseline in insomnia symptoms

    Time frame: at one-year

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

  12. Change from baseline in PTSD symptoms

    Time frame: at 10 weeks

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

  13. Change from baseline in PTSD symptoms

    Time frame: at one-year

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

  14. Change from baseline in stress

    Time frame: at 10 weeks

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

  15. Change from baseline in stress

    Time frame: at one-year

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

  16. Change from baseline in GAD-symptoms

    Time frame: at 10 weeks

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

  17. Change from baseline in GAD-symptoms

    Time frame: at one-year

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

  18. Change from baseline in pain catastrophizing

    Time frame: at 5 weeks

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

  19. Change from baseline in pain catastrophizing

    Time frame: at 10 weeks

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

  20. Change from baseline in pain catastrophizing

    Time frame: at one-year

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

  21. Change from baseline in coping strategies

    Time frame: at one-year

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

  22. Change from baseline in coping strategies

    Time frame: at 5 weeks

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

  23. Change from baseline in coping strategies

    Time frame: at 10 weeks

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

  24. Change from baseline in pain acceptance

    Time frame: at 5 weeks

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

  25. Change from baseline in pain acceptance

    Time frame: at 10 weeks

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

  26. Change from baseline in pain acceptance

    Time frame: at one-year

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

  27. Change from baseline in self efficacy

    Time frame: at 5 weeks

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

  28. Change from baseline in self efficacy

    Time frame: at 10 weeks

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

  29. Change from baseline in self efficacy

    Time frame: at one-year

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

  30. Treatment credibility rating

    Time frame: Baseline only

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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Uppsala University Hospital

Registry information

Official study title

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

Acronym: TIPPS

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Oct 20, 2017
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.