NCT00861393

Brief Summary

The purpose of the study is to determine whether or not a brief psychological treatment called cognitive behaviour therapy will help people who have suffered a spinal cord injury to cope better with their current circumstances.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 13, 2009

Status Verified

March 1, 2009

Enrollment Period

11 months

First QC Date

March 12, 2009

Last Update Submit

March 12, 2009

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

  • Symptom checklist -90-R (SCL-90-R) Depression Anxiety Stress Scales (DASS-21) Personality Assessment Inventory (PAI) PAI measure a broad range of psychological symptoms and personality characteristics.

    one year

Secondary Outcomes (1)

  • The Ways of Coping Scale- Revised (WOC-R) Community Integration Questionnaire (CIQ) Satisfaction with Life Scale (SWLS) Life satisfaction Checklist (LiSat-11) Stage of change Scales (SOC)

    one year

Study Arms (2)

CBT

OTHER
Behavioral: CBT

Waitlist

OTHER
Behavioral: Waitlist CBT

Interventions

CBTBEHAVIORAL

12 Session CBT group

CBT
Waitlist CBTBEHAVIORAL

Participants in the waitlist will receive CBT when first group has completed CBT and been tested.

Waitlist

Eligibility Criteria

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

You may qualify if:

  • between ages 18-65
  • diagnosed with spinal cord injury
  • currently endorsing significant distress as measured
  • able to provide informed consent
  • if taking psychoactive meds, on a stable dosage
  • are not currently enrolled in any other psychological treatment program
  • speak basic english with no diagnosis of communication disorder

You may not qualify if:

  • they endorse current suicidal ideation
  • have a Neurodegenerative disorder such as Multiple Sclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehabilitation Institute (Lyndhurst Center)

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

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

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 13, 2009

Record last verified: 2009-03

Locations

CA(1)