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

NCT03316846 | Completed

• 1 other identifier: 140371
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Depressive Symptoms; Anxiety; Stress, Psychological

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change from baseline in depressive symptoms

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

  at 10 weeks

• Change from baseline in depressive symptoms

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

  at one-year

• 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

  at 10 weeks

• 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

  at one-year

Secondary Outcomes (30)

• Change from baseline in anxiety sensitivity

  at 10 weeks

• Change from baseline in anxiety sensitivity

  at one-year

• Change from baseline in symptoms of depression and anxiety

  at 10 weeks

• Change from baseline in symptoms of depression and anxiety

  at one-year

• Change from baseline in pain disability

  at 10 weeks

Study Arms (2)

Internet-delivered therapy

EXPERIMENTAL

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

Behavioral: Internet-Delivered Cognitive Behavioral Therapy

Wait list control group

NO INTERVENTION

Wait list control group, receives treatment at later point.

Interventions

Internet-Delivered Cognitive Behavioral Therapy BEHAVIORAL

Internet-delivered therapy

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Department of Psychology, Uppsala University

Uppsala, Uppland, 75236, Sweden

Location

MeSH Terms

Conditions

Chronic Pain; Depression; Anxiety Disorders; Stress, Psychological

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Monica Buhrman, PhD

  Uppsala University

  STUDY DIRECTOR

• Gerhard Andersson, Professor

  Linkoeping University

  STUDY CHAIR

• Torsten Gordh, Professor

  Uppsala University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: October 20, 2017
• Study Start: September 13, 2016
• Primary Completion: May 1, 2017
• Study Completion: December 1, 2018
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

SE (1)