Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients

December 8, 2023 updated by: Gerhard Andersson

Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients: Randomised Controlled Trial

The aim of the present study was to investigate if guided Internet-delivered Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously undergone a multidisciplinary treatment but still have residual problems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study investigates Internet-delivered CBT as a tertiary intervention. This is motivated by the fact that many pain patients relapse after rehabilitation and some may be in need of additional treatment. The persons who fulfills the inclusion criteria undergoes a structured telephone interview. The study is a experimental design with a treatment and an active control group measured before and after a treatment period. The control group were invited to participate in a moderated online discussion forum. Follow up data was collected six months after the treatment.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Uppsala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • to have been medically investigated (within one year)
  • completed the multidisciplinary rehabilitation program
  • have residual symptoms after the rehabilitation treatment (defined as functional impairment caused by their pain)
  • have Internet access

Exclusion Criteria:

  • planned surgery
  • ongoing medical investigation that could impede participation in the study
  • suffering from acute physical or psychological conditions
  • people confined to wheelchairs
  • people not fluent with the Swedish language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet delivered CBT
Internet delivered cognitive behavioral intervention, 8 weeks treatment.
Behavioral: Guided Internet-based cognitive behavioural treatment
Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.
No Intervention: No intervention
Waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Coping Strategies Questionnaire (CSQ)
Time Frame: One week pre treatment, one week post treatment
The CSQ contains 50 items divided in eight scales that measures different cognitive and behavioral coping strategies. The different coping strategies are: diverting attention, re-interpreting pain sensations, coping self-statements, ignoring sensations, praying and hoping, catastrophizing, increased behavioral activities and pain behavior (Rosenthiel & Keefe, 1983). Change from baseline in the different subscales pre- and post treatment.
One week pre treatment, one week post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale, HADS
Time Frame: One week pre treatment, one week post treatment
HADS is a 14-item questionnaire, and is designed to measure anxiety and depression in non-psychiatric patients.
One week pre treatment, one week post treatment
Multidimensional Pain Inventory, MPI
Time Frame: One week pre treatment, one week post treatment
MPI, assess psychosocial and behavioural consequences of pain. It´s divided into 2 sections and consisting of 8 scales. These are: Pain Severity, Interference, Life Control, Affective Distress, Support, Punishing Responses, Solicitous Responses and Distracting Responses.
One week pre treatment, one week post treatment
Pain and Impairment Relationship Scale (PAIRS)
Time Frame: One week pre treatment, one week post treatment
PAIRS consist of 15 personal statements that reflect thoughts, attitudes and opinions about pain. The questionnaire assesses beliefs and attitudes that patients have regarding pain and ability to function despite discomfort.
One week pre treatment, one week post treatment
Quality of Life Inventory (QOLI)
Time Frame: One week pre treatment, one week post after treatment
QOLI contains 32 items for assessing life satisfaction. The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighborhood and community. Each item is rated in terms of importance and satisfaction.
One week pre treatment, one week post after treatment
Chronic Pain Acceptance Questionnaire (CPAQ)
Time Frame: One week pre treatment, one week post treatment
CPAQ contains 20 items divided in two scales, engagement and willingness. CPAQ measures acceptance in relation to chronic pain.
One week pre treatment, one week post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerhard Andersson

Investigators

  • Study Director: Gerhard Andersson, Professor, Linkoeping University
  • Principal Investigator: Monica Buhrman, MSc, Uppsala University
  • Study Chair: Timo Hursti, PhD, Uppsala University
  • Study Chair: Torsten Gordh, Professor, Uppsala University
  • Study Chair: Anna Fredriksson, MSc, Uppsala University
  • Study Chair: Gunnel Edström, MSc, Uppsala University
  • Study Chair: Dorna Shaffi, MSc, Uppsala University
  • Study Chair: Carolina Törnqvist, MSc, Uppsala University
  • Study Chair: Brjann Ljotsson, PhD, Karolinska Institutet, Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

December 7, 2011

First Submitted That Met QC Criteria

December 11, 2011

First Posted (Estimated)

December 13, 2011

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • smartaMB2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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