Optimizing a Wellbeing Program for Care-partners of Those With SCI

Depression Clinical Trial

Official title:

Optimizing a Wellbeing Program for Care-partners of Those With Spinal Cord Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06318832
• Other study ID #: 124609
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: Swati Mehta, PhD
• Phone: 519-685-8500
• Email: swati.mehta[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spinal cord injuries (SCI) have a devastating effect not only on individuals incurring the life changing event, but also on those who are involved in their care. Family care-partners of those with SCI (fcSCI) may experience significant negative effects including impaired mental health, high levels of burden, poor adjustment to role, decreased quality of life and strain on relationships. Cognitive behaviour therapy (CBT) is an evidence-based treatment strategy that helps individuals recognize and challenge their unhelpful thoughts and behaviours that contribute to their mental health concerns. However, barriers such as availability to specialized care, costs, rural and remote location, or concerns about stigma may limit access to care. Internet delivered CBT (ICBT) has the potential to reach a much wider group of people that may have unequal access to health care.

In a previous feasibility study, the team demonstrated the preliminary effectiveness of a tailored ICBT Wellbeing program for fcSCI. However, our understanding of which components of the program can result in optimal management is limited. The main purpose of this study is to evaluate the effectiveness of different components of the Wellbeing program including: therapist guidance, peer support groups, and booster sessions on symptoms of depression among fcSCI. The team will evaluate which intervention components result in meaningful improvement in symptoms of depression. Through collaborations with SCI community organizations and rehabilitation institutions, participants will be recruited across Canada. The researchers will also develop a model to examine the most cost-effective intervention package from the different components. The Wellbeing for fcSCI program can provide personalized service to individuals while being flexible and easily accessible, improving overall wellbeing and access to health care services.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 154
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older

2. Canadian residents

3. identify as fcSCI

4. living in the community

5. endorsing symptoms of depression (PHQ-9=5);

6. suicide risk score <8 (Suicide Behaviours Questionnaire (SBQ) (Osman et al. 2001)

7. speak and read English

8. able to access and be comfortable using computers and the internet

9. willing to provide the name of a physician as an emergency contact.

Exclusion Criteria:

1. are currently involved in another psychotherapeutic intervention

2. present with severe mental health disorder requiring face-to-face therapy (e.g., severe suicide ideation, severe substance abuse, recent history of psychosis, mania).

Those participants taking antidepressants will be included in the trial; medication use will be tracked.

Related Conditions & MeSH terms

• Anxiety
• Caregiver Burden
• Caregiver Burnout
• Depression
• Internet-Delivered Cognitive Behavioural Therapy
• Spinal Cord Injuries

Intervention

Other:
• ICBT
ICBT: Participants will receive the 10-week tailored ICBT Wellbeing program consists of 1) education about how taking on the role of care-partner can impact emotional and cognitive wellbeing through introduction to the CBT model; 2) structured problem solving; 3) cognitive therapy and thought challenging to manage one's wellbeing and impact of caregiving; 4) building communication and intimacy; 5) physical symptoms of depression (i.e., hypo-arousal), anxiety/anger (i.e., hyper-arousal); practicing behavioural activation and controlled relaxation; 6) overdoing-underdoing cycle of activity levels and issues around the fear avoidance of social, physical, and cognitive activities; practicing activity pacing and gradually tackling avoidance; 7) occurrence of setbacks in thought, physical, behavioural, and cognitive symptoms; signs of setbacks and creating setback plans.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

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 to 1 year follow up