ObesityTELE-BARICARENCT05258578
Tele-BARICARE to Manage COVID-19-Related Distress
A study testing Tele-CBT and Self-Help Resources in people with Obesity and Bariatric Surgery Candidate, run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
Background: Over 60% of Canadians are overweight or obese and more than half have a history of a mental illness. The COVID-19 pandemic has made it difficult for people living with obesity to manage their weight even after undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Mental Health Disorder
- What is being tested?
- Tele-CBT and Self-Help Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesCanada
- Study dates
- 6 Oct 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-operative adult bariatric patients (men, women and gender diverse individuals)
- fluent in English
- have internet access to complete online questionnaires
- meet a threshold of ≥ 5 on the Patient Health Questionnaire 9-Item scale (PHQ-9)24, a measure of depressive symptoms, or ≥ 18 on the Binge Eating Scale (BES)26, a common measure of dysregulated eating in this patient population
Who cannot join
- current active suicidal ideation
- current poorly controlled medical illness or psychiatric illness that would render Tele-CBT very difficult (e.g., psychotic disorder, bipolar disorder)
- active COVID-19 infection as it may cause neuropsychiatric symptoms that impact treatment engagement and confound study outcomes
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Recruiting
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4K7
Daniella Sandre, PsyD, CPsych, 613-798-5555 ext. 19592, dasandre@toh.ca
- Recruiting
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Julie Riendeau, PhD, CPsych, 807-684-6908, riendeaj@tbh.net
- Recruiting
Humber River Hospital
Toronto, Ontario, M3M 0B2
Nadine Akbar, MD, 416-242-1000 ext. 21203, nakbar@hrh.ca
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Samantha Leung, MSc, 416-603-5800 ext. 3103, samantha.leung@uhn.ca
About this study
Official title: Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients to Manage COVID-19 Pandemic Related Mental Health and Distress (TELE-BARICARE): A Randomized Controlled Trial to Determine Effectiveness and Adaptation for Marginalized Populations
Background: Over 60% of Canadians are overweight or obese and more than half have a history of a mental illness. The COVID-19 pandemic has made it difficult for people living with obesity to manage their weight even after undergoing bariatric surgery. These difficulties in combination with the stress of the pandemic can cause significant declines in mental health and well-being. Psychotherapy ("talk therapy") has been shown to be effective in helping to reduce mental health and disordered eating symptoms in patients managing obesity; however, there is limited data in the context of COVID-19.
Objective: This study will examine whether providing a convenient and accessible telephone-based psychotherapy during and potentially after the COVID-19 pandemic will lead to better mental health and disordered eating-related outcomes in patients managing obesity after weight loss surgery.
Read more
Hypothesis: Relative to the control group, those receiving psychotherapy will have lower mental health distress and eating disorder symptoms.
Methods: Participants recruited from 4 weight loss surgery programs across Ontario will be randomly assigned to one of two groups: 1) Control (7 weekly non-structured check-in emails and access to online COVID-19 related mental health resources) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy [a type of "talk therapy"] intervention focused on developing coping skills and specifically designed for weight loss surgery patients). Participants will complete measures of mental health distress, eating behaviours and a psychological distress scale prior to and immediately following the intervention.
Implications: If Tele-CBT is found to improve post-pandemic mental health distress and eating behaviours, it could be routinely offered to patients with other chronic medical conditions as a resource to help manage psychological distress and mental health concerns emerging during and after the COVID-19 pandemic.
Read the detailed description
Background: High-risk patient populations, such as those with chronic or pre-existing medical conditions, including obesity, have experienced worsening mental health, distress and eating behaviours as a result of COVID-19. Given that 63% of Canadians are classified as overweight or obese, the mental health distress associated with COVID-19 has the potential to adversely impact obesity outcomes, such as weight loss and quality of life, in patients living with obesity or undergoing bariatric surgery. Preliminary evidence for virtual mental health interventions during COVID-19 has not identified any interventions that specifically addressed psychological distress or disordered eating in patients with obesity. This is a concern given significant shifts from in-person to virtual multidisciplinary visits across obesity and bariatric programs during the pandemic.
Purpose and Research Plan: The purpose of the proposed research is to develop a virtual evidence-based treatment to improve disordered eating and psychological distress secondary to COVID-19 among diverse patients who are managing obesity after bariatric surgery. This study will be conducted in two parallel phases. Phase 1 is a multisite randomized controlled trial (RCT) to examine the efficacy of Tele-CBT vs. a control intervention in postoperative bariatric patients experiencing disordered eating and/or psychological distress. Qualitative exit interviews will also be conducted and data used to inform future adaptations of the intervention to meet patients' diverse needs during and post-pandemic. Phase 2 will consist of integrated knowledge translation and the creation of a diverse advisory committee to co-produce knowledge products and inform adaptation of Tele-CBT for diverse populations.
Impact of Research: Given the increase in mental health distress and obesogenic behaviours related to the COVID-19 pandemic, it is critical that patients have consistent access to psychosocial care. Building off our previous research, this study aims to demonstrate that Tele-CBT is an efficacious intervention for those experiencing distress secondary to the COVID-19 pandemic and to mitigate pandemic-related deteriorations in mental health, disordered eating, and weight management in obesity care. Moreover, by understanding how virtually/remotely delivered psychological interventions during COVID-19 are received and affect diverse patient populations, our study findings will inform the development and application of psychosocial treatments and services during COVID-19 and its recovery phase. Through our advisory committee, key stakeholders, and community partnerships, the investigators will disseminate our findings widely and create a plan to implement virtual psychosocial interventions in obesity care to meet the mental health needs likely to persist post-pandemic.
- Being tested
- Tele-CBT, Self-Help Resources
- Keywords
- Obesity, Bariatric Surgery, Mental Health, Disordered Eating, Cognitive Behavioural Therapy, Telephone Therapy
- Medical subject headings
- Obesity, Mental Disorders, Feeding and Eating Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-CBTBehavioural
The Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and problem solving and challenging negative thoughts. Participants are encouraged to complete CBT homework between sessions (i.e., completing food records, pleasurable activities and worksheets).
Self-Help ResourcesOther
Participants will be directed to the CAMH COVID-19 Self-Help webpage (www.camh.ca/covid19) to access coping tools to help with COVID-19 associated stress and anxiety, loss, grief and healing, stigma, and physical isolation.
| Study group | Role | What they receive |
|---|---|---|
| Tele-CBT Group | Experimental | Participants will receive 6 weekly Tele-CBT sessions and 1 final "booster" session 1 month later, all approximately 55-minutes in duration. Briefly, the Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and problem solving and challenging negative thoughts. Participants are encouraged to complete CBT homework between sessions (i.e., completing food records, pleasurable activities and worksheets). Five clinical psychology graduate students will work as study therapists under the supervision of Drs. Cassin and Sockalingam and will have biweekly case supervision meetings. Receives: Behavioral: Tele-CBT |
| Self-Help Resources Group | Active comparator | Participants will be directed to the CAMH COVID-19 Self-Help webpage (www.camh.ca/covid19) to access coping tools to help with COVID-19 associated stress and anxiety, loss, grief and healing, stigma, and physical isolation. Participants in the control arm will receive weekly check-in/reminder emails for the duration of the intervention period. Receives: Other: Self-Help Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Binge Eating Scale
The investigators will assess change in Binge Eating Scale (BES) scores at post-intervention and at 3-month follow-up compared to baseline. The BES is a 16-item self-report measure designed specifically for use with individuals with obesity and assesses the presence of binge eating characteristics indicative of an eating disorder. Scores on the BES range from 0 to 46 with moderate and severe levels of binge eating corresponding to cut-off scores of 18 and 27, respectively.
Measured: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Change in Patient Health Questionnaire-9 Item Scale
The investigators will assess change in Patient Health Questionnaire-9 Item Scale (PHQ-9) scores at post-intervention and at 3-month follow-up compared to baseline. The PHQ-9 consists of 9-items assessing depressive symptoms on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the PHQ-9 range from 0 to 27 with mild, moderate, moderately severe and severe levels of depressive symptoms corresponding to cut-off scores of 5, 10, 15 and 20, respectively.
Measured: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Secondary outcomes (4)
Emotional Eating Scale
The investigators will assess change in Emotional Eating Scale (EES) scores at post-intervention and at 3-month follow-up compared to baseline. The EES is a 25-item self-report measure that assesses a person's tendency to cope with negative affect through eating. The scale ranges from 0 (no desire) to 4 (overwhelming urge) and consists of questions that ask participants to rate the intensity of their urge to eat in response to 25 emotions. The EES is comprised of 3 subscales that reflect eating in response to anger/frustration, anxiety, and depression.
Measured: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Change in Generalized Anxiety Disorder-7 Item Scale
The investigators will assess change in Generalized Anxiety Disorder-7 Item Scale (GAD-7) scores at post-intervention and at 3-month follow-up compared to baseline. The GAD-7 is a 7-item self-report questionnaire assessing anxiety symptoms on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the GAD-7 range from 0 to 21 with mild, moderate and severe levels of anxiety symptoms corresponding to cut-off scores of 5, 10 and 15, respectively.
Measured: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Change in Loss of Control Over Eating Scale
The investigators will assess change in Loss of Control Over Eating Scale (LOCES) scores at post-intervention and at 3-month follow-up compared to baseline. The LOCES is a 24-item self-report measure intended to measure a global sense of loss of control overeating. Higher scores on the LOCES indicate a greater level of LOC-eating.
Measured: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Kessler Psychological Distress Scale
The investigators will assess change in Kessler (K6) scores at post-intervention and at 3-month follow-up compared to baseline. The K6 is a 6-item self-report questionnaire measuring psychological distress. Questions are scored from 0 (none of the time) to 4 (all of the time). Low scores indicate low levels of psychological distress, whereas high scores indicate high levels of psychological distress.
Measured: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start6 Oct 2022
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted in two parallel phases. Phase 1 is a multisite randomized controlled trial (RCT) to examine the efficacy of Tele-CBT vs. a control intervention in postoperative bariatric patients experiencing disordered eating and/or psychological distress. Qualitative exit interviews will also be conducted and data used to inform future adaptations of the intervention to meet patients' diverse needs during and post-pandemic. Phase 2 will consist of integrated knowledge translation and the creation of a diverse advisory committee to co-produce knowledge products and inform adaptation of Tele-CBT for diverse populations.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Toronto Metropolitan University, The Ottawa Hospital, Humber River Hospital, Thunder Bay Regional Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Stephanie E. Cassin, PhD, CPsych, Principal investigator, Toronto Metropolitan UniversityBranka Agic, MD, Principal investigator, Centre for Addiction and Mental Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258578
- Sponsor's protocol ID
- 22-5145
- Acronym
- TELE-BARICARE
- Status last verified
- May 2023
- First submitted
- 24 Feb 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD are to be shared with other researchers.
Publications
Sockalingam S, Leung SE, Agic B, Ma C, Hawa R, Wnuk S, Dash S, Jackson T, Akbar N, Forhan M, Cassin SE. Telephone-based cognitive behavioural therapy for patients with postoperative bariatric surgery to manage COVID-19 pandemic-related mental health issues and distress (TELE-BARICARE): a protocol for a randomised controlled trial. BMJ Open. 2022 Sep 15;12(9):e067393. doi: 10.1136/bmjopen-2022-067393.
PubMed 36109026
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients to Manage COVID-19 Pandemic Related Mental Health and Distress (TELE-BARICARE): A Randomized Controlled Trial to Determine Effectiveness and Adaptation for Marginalized Populations
- ClinicalTrials.gov ID
- NCT05258578
- Acronym / sponsor ID
- TELE-BARICARE / 22-5145
- Keywords
- Obesity, Bariatric Surgery, Mental Health, Disordered Eating, Cognitive Behavioural Therapy, Telephone Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Toronto Metropolitan University, The Ottawa Hospital, Humber River Hospital, Thunder Bay Regional Health Sciences Centre
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Over 60% of Canadians are overweight or obese and more than half have a history of a mental illness. The COVID-19 pandemic has made it difficult for people living with obesity to manage their weight even after undergoing bariatric surgery. These difficulties in combination with the stress of the pandemic can cause significant declines in mental health and well-being. Psychotherapy ("talk therapy") has been shown to be effective in helping to reduce mental health and disordered eating symptoms in patients managing obesity; however, there is limited data in the context of COVID-19.
Objective: This study will examine whether providing a convenient and accessible telephone-based psychotherapy during and potentially after the COVID-19 pandemic will lead to better mental health and disordered eating-related outcomes in patients managing obesity after weight loss surgery.
Hypothesis: Relative to the control group, those receiving psychotherapy will have lower mental health distress and eating disorder symptoms.
Methods: Participants recruited from 4 weight loss surgery programs across Ontario will be randomly assigned to one of two groups: 1) Control (7 weekly non-structured check-in emails and access to online COVID-19 related mental health resources) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy [a type of "talk therapy"] intervention focused on developing coping skills and specifically designed for weight loss surgery patients). Participants will complete measures of mental health distress, eating behaviours and a psychological distress scale prior to and immediately following the intervention.
Implications: If Tele-CBT is found to improve post-pandemic mental health distress and eating behaviours, it could be routinely offered to patients with other chronic medical conditions as a resource to help manage psychological distress and mental health concerns emerging during and after the COVID-19 pandemic.
Detailed description
Background: High-risk patient populations, such as those with chronic or pre-existing medical conditions, including obesity, have experienced worsening mental health, distress and eating behaviours as a result of COVID-19. Given that 63% of Canadians are classified as overweight or obese, the mental health distress associated with COVID-19 has the potential to adversely impact obesity outcomes, such as weight loss and quality of life, in patients living with obesity or undergoing bariatric surgery. Preliminary evidence for virtual mental health interventions during COVID-19 has not identified any interventions that specifically addressed psychological distress or disordered eating in patients with obesity. This is a concern given significant shifts from in-person to virtual multidisciplinary visits across obesity and bariatric programs during the pandemic.
Purpose and Research Plan: The purpose of the proposed research is to develop a virtual evidence-based treatment to improve disordered eating and psychological distress secondary to COVID-19 among diverse patients who are managing obesity after bariatric surgery. This study will be conducted in two parallel phases. Phase 1 is a multisite randomized controlled trial (RCT) to examine the efficacy of Tele-CBT vs. a control intervention in postoperative bariatric patients experiencing disordered eating and/or psychological distress. Qualitative exit interviews will also be conducted and data used to inform future adaptations of the intervention to meet patients' diverse needs during and post-pandemic. Phase 2 will consist of integrated knowledge translation and the creation of a diverse advisory committee to co-produce knowledge products and inform adaptation of Tele-CBT for diverse populations.
Impact of Research: Given the increase in mental health distress and obesogenic behaviours related to the COVID-19 pandemic, it is critical that patients have consistent access to psychosocial care. Building off our previous research, this study aims to demonstrate that Tele-CBT is an efficacious intervention for those experiencing distress secondary to the COVID-19 pandemic and to mitigate pandemic-related deteriorations in mental health, disordered eating, and weight management in obesity care. Moreover, by understanding how virtually/remotely delivered psychological interventions during COVID-19 are received and affect diverse patient populations, our study findings will inform the development and application of psychosocial treatments and services during COVID-19 and its recovery phase. Through our advisory committee, key stakeholders, and community partnerships, the investigators will disseminate our findings widely and create a plan to implement virtual psychosocial interventions in obesity care to meet the mental health needs likely to persist post-pandemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be conducted in two parallel phases. Phase 1 is a multisite randomized controlled trial (RCT) to examine the efficacy of Tele-CBT vs. a control intervention in postoperative bariatric patients experiencing disordered eating and/or psychological distress. Qualitative exit interviews will also be conducted and data used to inform future adaptations of the intervention to meet patients' diverse needs during and post-pandemic. Phase 2 will consist of integrated knowledge translation and the creation of a diverse advisory committee to co-produce knowledge products and inform adaptation of Tele-CBT for diverse populations.
| Arm | Type | Receives |
|---|---|---|
| Tele-CBT Group | Experimental | Behavioral: Tele-CBTParticipants will receive 6 weekly Tele-CBT sessions and 1 final "booster" session 1 month later, all approximately 55-minutes in duration. Briefly, the Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and problem solving and challenging negative thoughts. Participants are encouraged to complete CBT homework between sessions (i.e., completing food records, pleasurable activities and worksheets). Five clinical psychology graduate students will work as study therapists under the supervision of Drs. Cassin and Sockalingam and will have biweekly case supervision meetings. |
| Self-Help Resources Group | Active comparator | Other: Self-Help ResourcesParticipants will be directed to the CAMH COVID-19 Self-Help webpage (www.camh.ca/covid19) to access coping tools to help with COVID-19 associated stress and anxiety, loss, grief and healing, stigma, and physical isolation. Participants in the control arm will receive weekly check-in/reminder emails for the duration of the intervention period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- post-operative adult bariatric patients (men, women and gender diverse individuals)
- fluent in English
- have internet access to complete online questionnaires
- meet a threshold of ≥ 5 on the Patient Health Questionnaire 9-Item scale (PHQ-9)24, a measure of depressive symptoms, or ≥ 18 on the Binge Eating Scale (BES)26, a common measure of dysregulated eating in this patient population
Key exclusion criteria (3 listed)
- current active suicidal ideation
- current poorly controlled medical illness or psychiatric illness that would render Tele-CBT very difficult (e.g., psychotic disorder, bipolar disorder)
- active COVID-19 infection as it may cause neuropsychiatric symptoms that impact treatment engagement and confound study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-CBTThe Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and problem solving and challenging negative thoughts. Participants are encouraged to complete CBT homework between sessions (i.e., completing food records, pleasurable activities and worksheets). | Behavioural | Tele-CBT Group |
| Self-Help ResourcesParticipants will be directed to the CAMH COVID-19 Self-Help webpage (www.camh.ca/covid19) to access coping tools to help with COVID-19 associated stress and anxiety, loss, grief and healing, stigma, and physical isolation. | Other | Self-Help Resources Group |
Primary outcome
Change in Binge Eating Scale
Time frame: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
The investigators will assess change in Binge Eating Scale (BES) scores at post-intervention and at 3-month follow-up compared to baseline. The BES is a 16-item self-report measure designed specifically for use with individuals with obesity and assesses the presence of binge eating characteristics indicative of an eating disorder. Scores on the BES range from 0 to 46 with moderate and severe levels of binge eating corresponding to cut-off scores of 18 and 27, respectively.
Change in Patient Health Questionnaire-9 Item Scale
Time frame: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
The investigators will assess change in Patient Health Questionnaire-9 Item Scale (PHQ-9) scores at post-intervention and at 3-month follow-up compared to baseline. The PHQ-9 consists of 9-items assessing depressive symptoms on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the PHQ-9 range from 0 to 27 with mild, moderate, moderately severe and severe levels of depressive symptoms corresponding to cut-off scores of 5, 10, 15 and 20, respectively.
4 secondary outcomes
Emotional Eating Scale
Time frame: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Change in Generalized Anxiety Disorder-7 Item Scale
Time frame: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Change in Loss of Control Over Eating Scale
Time frame: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Kessler Psychological Distress Scale
Time frame: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 36109026Sockalingam S, Leung SE, Agic B, Ma C, Hawa R, Wnuk S, Dash S, Jackson T, Akbar N, Forhan M, Cassin SE. Telephone-based cognitive behavioural therapy for patients with postoperative bariatric surgery to manage COVID-19 pandemic-related mental health issues and distress (TELE-BARICARE): a protocol for a randomised controlled trial. BMJ Open. 2022 Sep 15;12(9):e067393. doi: 10.1136/bmjopen-2022-067393.
- Individual participant dataSharing planned: No. No IPD are to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie E. Cassin, PhD, CPsych principal investigator
Toronto Metropolitan University
Branka Agic, MD principal investigator
Centre for Addiction and Mental Health Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-CBT and Self-Help Resources in people with Obesity and Bariatric Surgery Candidate, run by University Health Network, Toronto at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjeev Sockalingam, MD (416 535-8501 ext. 32178, sanjeev.sockalingam@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Binge Eating Scale (time frame: Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05258578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.