NCT01329861

Brief Summary

The aim of this study was to investigate whether an Internet-based cognitive behavioural intervention would have an effect on the symptoms of chronic back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
Last Updated

April 6, 2011

Status Verified

April 1, 2011

Enrollment Period

11 months

First QC Date

April 4, 2011

Last Update Submit

April 5, 2011

Conditions

Keywords

chronic back paininternet based treatmentpain management programmecognitive behavioural therapyminimal therapist contact

Outcome Measures

Primary Outcomes (1)

  • Coping Strategies Questionnaire - catastrophizing subscale (CSQ)

    Change from baseline in the catastrophizing subscale to two weeks post treatment.

    Two weeks pre treatment to two weeks post treatment

Secondary Outcomes (4)

  • Multidimensional Pain Inventory (MPI)

    Change from baseline Two weeks pre treatment to two weeks post treatment

  • Pain and Impairment Relationship Scale (PAIRS)

    Change from baseline Two weeks pre treatment to two weeks post treatment.

  • Hospital Anxiety and Depression Scale(HADS).

    Change from baseline Two weeks pre treatment to two weeks post treatment.

  • Quality of Life Inventory (QOLI)

    Change from baseline Two weeks pre treatment to two weeks post treatment.

Study Arms (2)

Internet delivered CBT

EXPERIMENTAL

Internet delivered cognitive behavioral intervention, 8 weeks treatment.

Behavioral: Guided Internet-based cognitive behavioural treatment

Control condition

NO INTERVENTION

Wait-list condition, received treatment after post-treatment assessment.

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:

  • age between 18-65 years
  • access to the Internet
  • having been in contact with a physician
  • back pain of chronic nature
  • in current employment or on short-term sick leave(not longer than 6 months)

You may not qualify if:

  • wheelchair user
  • surgical treatment planned
  • history of cardiovascular treatment
  • severe depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, Sweden

Location

Study Officials

  • Gerhard Andersson, Professor

    Linkoeping University

    STUDY DIRECTOR
  • Monica Buhrman, MSc

    Uppsala University

    PRINCIPAL INVESTIGATOR
  • Elisabeth Nilsson-Ihrfelt, MSc

    Uppsala University

    STUDY CHAIR
  • Maria Jannert, MSc

    Linkoeping University

    STUDY CHAIR
  • Lars Ström, PhD

    Livanda (private practice) Västerås

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 6, 2011

Study Start

June 1, 2004

Primary Completion

May 1, 2005

Study Completion

August 1, 2005

Last Updated

April 6, 2011

Record last verified: 2011-04

Locations