Clinical trial NCT06318832: Optimizing a Wellbeing Program for Care-partners of Those With SCI
Official title: Optimizing a Wellbeing Program for Care-partners of Those With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Internet-Delivered Cognitive Behavioural Therapy
Depression
Anxiety
Spinal Cord Injuries
Caregiver Burnout
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in depression
timeFrame: Baseline to 1 year follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: