Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03457714
Other study ID # 2017-104
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 7, 2017
Est. completion date December 31, 2018

Study information

Verified date April 2019
Source University of Regina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In Canada the prevalence of spinal cord injury (SCI) is approximately 85,556, with incidence rates of traumatic and non-traumatic SCI at 1,785 and 2,286 cases per year, respectively. Common secondary health conditions experienced by individuals with SCI include psychological distress and pain. Appropriate management of these secondary conditions, through a multidisciplinary approach, is imperative as they have been shown to contribute to slower recovery, increased negative outcomes, and greater rates of rehospitalizations and health care utilization. However, resource limitations can restrict the ability of service providers to deliver these integrative biopsychosocial approaches in the community. In Canada over 37% of individuals with SCI expressed a need for emotional counselling; of these, only 43% felt that these needs were met. Transportation can also be a significant issue for persons with SCI, with 87% and 73% respectively expressing a need for short- and long-distance transportation. Guided internet delivered cognitive behavioural therapy (ICBT) program offers an alternative approach for psychosocial service delivery in the community. The program provides online structured self-help modules based on the principles of cognitive behavioural therapy (CBT) in combination with guidance from a coach through weekly emails and telephone calls. ICBT has shown to have a greater reduction in levels of anxiety and depression post treatment compared to a waitlist control group, and these levels were maintained at both 3 and 12 month follow-ups. ICBT was shown to have similar effects to face-to-face CBT. These studies demonstrate that guided ICBT is a safe and effective alternative to face-to-face interventions and it may be beneficial for under serviced populations. Hence, examination of its effectiveness is warranted in the SCI population which faces various psychological and somatic secondary issues. Participants with SCI will receive a 8 week guided ICBT program called the Chronic Conditions Course for persons with SCI. The program is completed over 8 weeks with once a week guidance from a coach. The guided course consists of five lessons, "Do It Yourself" activities, and case vignettes adapted from persons with SCI. The course also provides guidance and resources on other essential skills for persons with SCI, including communicating with health care professional, managing chronic pain, and sleep hygiene. Psychosocial outcomes will be assessed at baseline, 8 weeks, and at 3 months. Data on intervention usage and satisfaction measures will also be examined through a qualitative interview. Caregivers of participants will be asked to complete self-report measures and a qualitative interview regarding their caregiver burden.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- residing in Canada

- diagnosed with spinal cord injury

- able to access a computer and internet service

- willing to provide a physician as emergency contact

Exclusion Criteria:

- high suicide risk

- suicide attempt or hospitalization in the last year

- primary problems with psychosis, alcohol or drug problems, mania

- currently receiving active psychological treatment for anxiety or depression

- not present in Canada during treatment

- concerns about online therapy

Study Design


Intervention

Behavioral:
Guided ICBT for persons with Spinal Cord Injury
An 8-week guided internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a spinal cord injury. In addition to the online program, a guide with experience delivering ICBT will provide support by email or telephone once a week. The guide will spend approximately 15 minutes per week/per client.
Other:
Survey
Caregiver burden and mental health will be assessed through online questionnaires.

Locations

Country Name City State
Canada Online Therapy Unit, University of Regina Regina Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Regina

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in depression Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27. baseline, start of each Lesson 2-5, 8 weeks, 3 months
Primary Change in anxiety Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21 baseline, start of each Lesson 2-5, 8 weeks, 3 months
Primary Change in Caregiver Burden from baseline to 8 weeks (Caregivers of persons with SCI only) Caregiver burden questionnaire. The tool has 12 items. Total scores ranging from 0 to 18. Higher scores indicate greater burden baseline, 8 weeks
Secondary Pain (Persons with SCI only) International Spinal Cord Injury Pain Basic Data Set v2.0 ISCIPBDS baseline, 8 weeks, 3 months
Secondary Pain interference (Persons with SCI only) Brief Pain Inventory Short Form; BPI-SF baseline, 8 weeks, 3 months
Secondary Quality of life (Persons with SCI only) Spinal Cord Injury Quality of Life Short Form; SCI-QoL-SF baseline, 8 weeks, 3 months
Secondary Service usage (Persons with SCI only) baseline, 8 weeks, 3 months
Secondary Quality of Life (Caregivers of persons with SCI only) EQ5D baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A