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Cognitive Behavioural Therapy (CBT) For Improving Emotional Well Being in Spinal Cord Injuries (SCI) (CBT)

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CBT
Waitlist CBT
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Toronto Rehabilitation Institute (Lyndhurst Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CBT

Waitlist

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
March 12, 2009
Last Updated
March 12, 2009
Sponsor
Toronto Rehabilitation Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00861393
Brief Title
Cognitive Behavioural Therapy (CBT) For Improving Emotional Well Being in Spinal Cord Injuries (SCI)
Acronym
CBT
Official Title
The Impact of a Brief Cognitive Behavior Therapy Intervention Aimed at Improving Emotional Well-Being and Quality of Life for Individuals With Spinal Cord Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Toronto Rehabilitation Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The goal of the current proposed research project is to investigate the potential efficacy of a group cognitive behavioural therapy (CBT) intervention aimed at improving emotional well-being, specifically mood, adjustment and quality of life (QOL), after Spinal Cord Injury(SCI). The intervention will be adapted to meet the unique needs of patients suffering from an SCI. The study objectives are: (1) to evaluate the impact of a brief CBT intervention aimed at decreasing emotional distress and improving quality of life; (2) to evaluate the sustainability of CBT therapeutic gains over time; (3) to conduct sub group analyses in order to better determine why some patients may improve post CBT, while others may not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Other
Arm Title
Waitlist
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
12 Session CBT group
Intervention Type
Behavioral
Intervention Name(s)
Waitlist CBT
Intervention Description
Participants in the waitlist will receive CBT when first group has completed CBT and been tested.
Primary Outcome Measure Information:
Title
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
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)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: they endorse current suicidal ideation have a Neurodegenerative disorder such as Multiple Sclerosis
Facility Information:
Facility Name
Toronto Rehabilitation Institute (Lyndhurst Center)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3V9
Country
Canada

12. IPD Sharing Statement

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Cognitive Behavioural Therapy (CBT) For Improving Emotional Well Being in Spinal Cord Injuries (SCI)

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