NCT01491269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable chronic-pain

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

August 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

December 7, 2011

Last Update Submit

December 8, 2023

Conditions

Keywords

chronic paininternet delivered CBTtertiary interventionmindfulnessapplied relaxationguided self help

Outcome Measures

Primary Outcomes (1)

  • The Coping Strategies Questionnaire (CSQ)

    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 Outcomes (5)

  • Hospital Anxiety and Depression Scale, HADS

    One week pre treatment, one week post treatment

  • Multidimensional Pain Inventory, MPI

    One week pre treatment, one week post treatment

  • Pain and Impairment Relationship Scale (PAIRS)

    One week pre treatment, one week post treatment

  • Quality of Life Inventory (QOLI)

    One week pre treatment, one week post after treatment

  • Chronic Pain Acceptance Questionnaire (CPAQ)

    One week pre treatment, one week post treatment

Study Arms (2)

Internet delivered CBT

EXPERIMENTAL

Internet delivered cognitive behavioral intervention, 8 weeks treatment.

Behavioral: Guided Internet-based cognitive behavioural treatment

No intervention

NO INTERVENTION

Waitlist

Interventions

Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.

Internet delivered CBT

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gerhard Andersson, Professor

    Linkoeping University

    STUDY DIRECTOR
  • Monica Buhrman, MSc

    Uppsala University

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor, Linkoeping University

Study Record Dates

First Submitted

December 7, 2011

First Posted

December 13, 2011

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

December 14, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations