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

Spinal Cord Injuries Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00861393
• Other study ID #: CBT-08-06
• Status: Active, not recruiting
• Phase: N/A
• First received: March 12, 2009
• Last updated: March 12, 2009
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: March 2009
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Behavioral:
• CBT
12 Session CBT group
• Waitlist CBT
Participants in the waitlist will receive CBT when first group has completed CBT and been tested.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute (Lyndhurst Center)	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No