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

• Sponsor: Toronto Rehabilitation Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00861393
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 4.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Behavioral: CBT; Behavioral: Waitlist CBT	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2009
• Anticipated Primary Completion Date: Jan 1, 2010
• Anticipated Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: CBT	Behavioral: CBT; 12 Session CBT group
Other: Waitlist	Behavioral: Waitlist CBT; Participants in the waitlist will receive CBT when first group has completed CBT and been tested.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Rehabilitation Institute (Lyndhurst Center)	Toronto	Ontario	Canada	M4G 3V9

Sponsors and Collaborators

• Toronto Rehabilitation Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00861393
• Other Study ID Numbers: CBT-08-06
• First Posted: Mar 13, 2009
• Last Update Posted: Mar 13, 2009
• Last Verified: Mar 1, 2009

• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of Mar 13, 2009