ObesityNCT02920112
Tele-CBT One Year Following Bariatric Surgery: A Pilot Study
A study testing Telephone based Cognitive Behavioral Therapy in people with Obesity, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This second phase of a pilot study (non-drug) will examine the effectiveness and feasibility of Telephone based Cognitive Behavioural Therapy (Tele-CBT) as an additional treatment to the usual standard of care in bariatric surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Telephone based Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Mar 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in English.
- Have access to a telephone and a computer with internet connection.
- Have the capacity to provide informed consent.
- Patient is at approximately one year post-surgery at the Bariatric Surgery Program at Toronto Western Hospital.
Who cannot join
- Active suicidal ideation.
- Active serious mental illness
- Active severe depression
- Active severe anxiety
- Active symptoms of post-traumatic stress disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital with the University Health Network
Toronto, Ontario, M5T 2S8
About this study
Official title: Telephone-Based Cognitive Behavioural Therapy for Bariatric Surgery Patients One Year Following Bariatric Surgery: A Pilot Study
This second phase of a pilot study (non-drug) will examine the effectiveness and feasibility of Telephone based Cognitive Behavioural Therapy (Tele-CBT) as an additional treatment to the usual standard of care in bariatric surgery patients. Participants one year post-surgery will receive six sessions of Tele-CBT and complete measures before, during, immediately after, and one year after participation in the study.
Read the detailed description
Obesity is an increasingly prevalent chronic condition (Ogden et al., 2006) which is associated with significant health consequences, including type 2 diabetes, obstructive sleep apnea, hypertension, and hyperlipidemia (Bray, 2004). Bariatric surgery is the most effective treatment for patients with extreme obesity (Colquitt et al., 2005). Unfortunately, it has been estimated that 20 to 50% of patients begin to regain their weight within the first 1 ½ to 2 years, and improvements in medical comorbidities dissipate with weight regain (Hsu et al., 1998; Shah et al., 2006). In light of the high relapse rates following bariatric surgery, research on non-surgical factors that influence the outcome of bariatric surgery, such as psychiatric comorbidity, has become increasingly important (Hsu et al., 1998). Up to 55% of bariatric surgery candidates have an Axis I disorder at the time of the initial assessment, with the most common diagnoses being eating disorders (37%), affective disorders (32%), and anxiety disorders (15%) (Muhlhans et al., 2009). Despite accumulating evidence indicating that psychiatric comorbidity is associated with poorer surgical outcomes, psychological interventions are not routinely offered in Bariatric Surgery programs. It has been suggested that cognitive behavioural therapy (CBT) could be helpful in maintaining weight loss (Kalarchian \& Marcus, 2003). We have published a paper on the feasibility of the protocol using a small sample and producing promising eating improvements post-intervention (Cassin et al., 2013). A more recent study (Cassin et al., 2016) of the first phase of this study with Tele-CBT delivered 6 months before surgery indicated significant improvements in binge eating, emotional eating, and depressive symptoms, compared to a control group. These results are similar to other studies employing CBT for bariatric surgery patients (e.g. Gade et al., 2014). We have recently published on the outcomes for Tele-CBT delivered 6 months post-surgery (Sockalingam, Cassin, Wnuk, Du, Jackson, Hawa, \& Parikh, 2016) that showed significant reductions in scores of binge eating, emotional eating, depression, and anxiety. The same measures used in the first phase of the study (Cassin et al., 2016; Sockalingam et al., 2016) will be used in this second phase, looking at Tele-CBT delivered to patients at one year after surgery. Comparisons between the efficacy of Tele-CBT based on responses to measures will be made for participants receiving the intervention at 6 months before surgery, 6 months after surgery, and 1 year after surgery.
- Conditions
- Obesity
- Being tested
- Telephone based Cognitive Behavioral Therapy
- Keywords
- Obesity, Bariatric Surgery, Bariatrics, Cognitive Therapy, Binge eating
- Medical subject headings
- Obesity, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone based Cognitive Behavioral TherapyBehavioural
Also called Tele-CBT
6 sessions of Telephone based Cognitive Behavioral Therapy over the telephone, lasting approximately 60 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| One year post-op Tele-CBT | Experimental | This group will receive Telephone based Cognitive Behavioral Therapy (Tele-CBT) one year after bariatric surgery. Receives: Behavioral: Telephone based Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Eating Pathology: Emotional Eating Scale (EES)
25-item self-report measure that assesses tendency to cope with negative affect by eating.
Measured: Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention,
Changes in Eating Pathology: Binge Eating Scale (BES)
Measured: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Changes in Eating Pathology: Eating Disorder Examination Questionnaire (EDEQ)
41-item self-report measure that assesses eating disorder psychopathology. Only 3 items regarding binge eating will be used. Will be used to measure changes in eating pathology.
Measured: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Changes in Eating Pathology: Ontario Bariatric Eating Self-Efficacy Scale (OBESE) - Changes in Eating Pathology
28-item self-report measure of eating self-efficacy in bariatric patients.
Measured: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Secondary outcomes (6)
Satisfaction with Therapy: Working Alliance Inventory - Short Form (WAI-SF)
12-item self-report measure that assesses the alliance between patient and therapist.
Measured: Weekly up to 6 weeks during intervention and immediately post-intervention
Changes in Depression Severity
Measured with Patient Health Questionnaire (PHQ-9), a 9-item self-report measure of depression severity.
Measured: Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention
Changes in Anxiety Severity
Measured with Generalized Anxiety Disorder Questionnaire (GAD-7), a 7-item self-report measure of anxiety severity.
Measured: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Changes in Health-Related Quality of Life
Measured with Short-Form Health Survey (SF-36), a 36-item self-report measure of health-related quality of life.
Measured: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Satisfaction with Therapy: Tele-CBT Client Change Interview
a 9-item self-report measure that qualitatively assesses patient experience with the Tele-CBT treatment
Measured: Weekly up to 6 weeks during intervention, immediately post-intervention, 1 year after intervention
Satisfaction with Therapy: Helpful Aspects of Therapy Form (HAT)
brief, open-ended questionnaire completed by participants after each session. Participants are asked to describe in their own words the most helpful event in the session, and to rate how helpful it was.
Measured: Weekly up to 6 weeks during intervention and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjeev Sockalingam, University Health Network, Toronto
- Investigators
- Sanjeev Sockalingam, MD, FRCPC, Principal investigator, University of Toronto, Toronto Western HospitalStephanie E Cassin, PhD, CPsych, Principal investigator, Toronto Metropolitan UniversityRaed Hawa, MD, FRCPC, Study director, University of Toronto, Toronto Western HospitalSusan Wnuk, PhD, CPsych, Study director, University of Toronto, Toronto Western HospitalTimothy Jackson, MD, FRCSC, Study director, University of Toronto, Toronto Western HospitalChau Du, MSc, Study director, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920112
- Sponsor's protocol ID
- 11-0622-BE2
- Other IDs
- Grant #317877
- Status last verified
- Apr 2018
- First submitted
- 8 Sep 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly in order to protect patient confidentiality. Aggregate and anonymous data will be shared in peer-reviewed journal articles and scientific presentations.
Publications
Cassin SE, Sockalingam S, Du C, Wnuk S, Hawa R, Parikh SV. A pilot randomized controlled trial of telephone-based cognitive behavioural therapy for preoperative bariatric surgery patients. Behav Res Ther. 2016 May;80:17-22. doi: 10.1016/j.brat.2016.03.001. Epub 2016 Mar 10.
PubMed 26990279Cassin SE, Sockalingam S, Wnuk S, Strimas R, Royal S, Hawa R, Parikh SV. Cognitive Behavioral Therapy for Bariatric Surgery Patients: Preliminary Evidence for Feasibility, Acceptability, and Effectiveness. Cognitive and Behavioral Practice 20(4): 529-543, 2013.
Sockalingam S, Cassin SE, Wnuk S, Du C, Jackson T, Hawa R, Parikh SV. A Pilot Study on Telephone Cognitive Behavioral Therapy for Patients Six-Months Post-Bariatric Surgery. Obes Surg. 2017 Mar;27(3):670-675. doi: 10.1007/s11695-016-2322-x.
PubMed 27491293Santiago VA, Cassin SE, Wnuk S, Du C, Hawa R, Parikh SV, Sockalingam S. "If you're offered help, take it": A qualitative study examining bariatric patients' experience of telephone-based cognitive behavioural therapy. Clin Obes. 2021 Apr;11(2):e12431. doi: 10.1111/cob.12431. Epub 2020 Nov 29.
PubMed 33251753Sockalingam S, Leung SE, Hawa R, Wnuk S, Parikh SV, Jackson T, Cassin SE. Telephone-based cognitive behavioural therapy for female patients 1-year post-bariatric surgery: A pilot study. Obes Res Clin Pract. 2019 Sep-Oct;13(5):499-504. doi: 10.1016/j.orcp.2019.07.003. Epub 2019 Aug 10.
PubMed 31409544
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Based Cognitive Behavioural Therapy for Bariatric Surgery Patients One Year Following Bariatric Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT02920112
- Acronym / sponsor ID
- 11-0622-BE2
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric Surgery, Bariatrics, Cognitive Therapy, Binge eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 30 Sep 2016 (estimated)
- 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.
This second phase of a pilot study (non-drug) will examine the effectiveness and feasibility of Telephone based Cognitive Behavioural Therapy (Tele-CBT) as an additional treatment to the usual standard of care in bariatric surgery patients. Participants one year post-surgery will receive six sessions of Tele-CBT and complete measures before, during, immediately after, and one year after participation in the study.
Detailed description
Obesity is an increasingly prevalent chronic condition (Ogden et al., 2006) which is associated with significant health consequences, including type 2 diabetes, obstructive sleep apnea, hypertension, and hyperlipidemia (Bray, 2004). Bariatric surgery is the most effective treatment for patients with extreme obesity (Colquitt et al., 2005). Unfortunately, it has been estimated that 20 to 50% of patients begin to regain their weight within the first 1 ½ to 2 years, and improvements in medical comorbidities dissipate with weight regain (Hsu et al., 1998; Shah et al., 2006). In light of the high relapse rates following bariatric surgery, research on non-surgical factors that influence the outcome of bariatric surgery, such as psychiatric comorbidity, has become increasingly important (Hsu et al., 1998). Up to 55% of bariatric surgery candidates have an Axis I disorder at the time of the initial assessment, with the most common diagnoses being eating disorders (37%), affective disorders (32%), and anxiety disorders (15%) (Muhlhans et al., 2009). Despite accumulating evidence indicating that psychiatric comorbidity is associated with poorer surgical outcomes, psychological interventions are not routinely offered in Bariatric Surgery programs. It has been suggested that cognitive behavioural therapy (CBT) could be helpful in maintaining weight loss (Kalarchian \& Marcus, 2003). We have published a paper on the feasibility of the protocol using a small sample and producing promising eating improvements post-intervention (Cassin et al., 2013). A more recent study (Cassin et al., 2016) of the first phase of this study with Tele-CBT delivered 6 months before surgery indicated significant improvements in binge eating, emotional eating, and depressive symptoms, compared to a control group. These results are similar to other studies employing CBT for bariatric surgery patients (e.g. Gade et al., 2014). We have recently published on the outcomes for Tele-CBT delivered 6 months post-surgery (Sockalingam, Cassin, Wnuk, Du, Jackson, Hawa, \& Parikh, 2016) that showed significant reductions in scores of binge eating, emotional eating, depression, and anxiety. The same measures used in the first phase of the study (Cassin et al., 2016; Sockalingam et al., 2016) will be used in this second phase, looking at Tele-CBT delivered to patients at one year after surgery. Comparisons between the efficacy of Tele-CBT based on responses to measures will be made for participants receiving the intervention at 6 months before surgery, 6 months after surgery, and 1 year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One year post-op Tele-CBT | Experimental | Behavioral: Telephone based Cognitive Behavioral TherapyThis group will receive Telephone based Cognitive Behavioral Therapy (Tele-CBT) one year after bariatric surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fluent in English.
- Have access to a telephone and a computer with internet connection.
- Have the capacity to provide informed consent.
- Patient is at approximately one year post-surgery at the Bariatric Surgery Program at Toronto Western Hospital.
Key exclusion criteria (5 listed)
- Active suicidal ideation.
- Active serious mental illness
- Active severe depression
- Active severe anxiety
- Active symptoms of post-traumatic stress disorder
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 |
|---|---|---|
| Telephone based Cognitive Behavioral TherapyAlso: Tele-CBT6 sessions of Telephone based Cognitive Behavioral Therapy over the telephone, lasting approximately 60 minutes each. | Behavioural | One year post-op Tele-CBT |
Primary outcome
Changes in Eating Pathology: Emotional Eating Scale (EES)
Time frame: Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention,
25-item self-report measure that assesses tendency to cope with negative affect by eating.
Changes in Eating Pathology: Binge Eating Scale (BES)
Time frame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Changes in Eating Pathology: Eating Disorder Examination Questionnaire (EDEQ)
Time frame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
41-item self-report measure that assesses eating disorder psychopathology. Only 3 items regarding binge eating will be used. Will be used to measure changes in eating pathology.
Changes in Eating Pathology: Ontario Bariatric Eating Self-Efficacy Scale (OBESE) - Changes in Eating Pathology
Time frame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
28-item self-report measure of eating self-efficacy in bariatric patients.
6 secondary outcomes
Satisfaction with Therapy: Working Alliance Inventory - Short Form (WAI-SF)
Time frame: Weekly up to 6 weeks during intervention and immediately post-intervention
Changes in Depression Severity
Time frame: Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention
Changes in Anxiety Severity
Time frame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Changes in Health-Related Quality of Life
Time frame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Satisfaction with Therapy: Tele-CBT Client Change Interview
Time frame: Weekly up to 6 weeks during intervention, immediately post-intervention, 1 year after intervention
Satisfaction with Therapy: Helpful Aspects of Therapy Form (HAT)
Time frame: Weekly up to 6 weeks during intervention and immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Background: PubMed 26990279Cassin SE, Sockalingam S, Du C, Wnuk S, Hawa R, Parikh SV. A pilot randomized controlled trial of telephone-based cognitive behavioural therapy for preoperative bariatric surgery patients. Behav Res Ther. 2016 May;80:17-22. doi: 10.1016/j.brat.2016.03.001. Epub 2016 Mar 10.
- BackgroundCassin SE, Sockalingam S, Wnuk S, Strimas R, Royal S, Hawa R, Parikh SV. Cognitive Behavioral Therapy for Bariatric Surgery Patients: Preliminary Evidence for Feasibility, Acceptability, and Effectiveness. Cognitive and Behavioral Practice 20(4): 529-543, 2013.
- Background: PubMed 27491293Sockalingam S, Cassin SE, Wnuk S, Du C, Jackson T, Hawa R, Parikh SV. A Pilot Study on Telephone Cognitive Behavioral Therapy for Patients Six-Months Post-Bariatric Surgery. Obes Surg. 2017 Mar;27(3):670-675. doi: 10.1007/s11695-016-2322-x.
- Derived from this study: PubMed 33251753Santiago VA, Cassin SE, Wnuk S, Du C, Hawa R, Parikh SV, Sockalingam S. "If you're offered help, take it": A qualitative study examining bariatric patients' experience of telephone-based cognitive behavioural therapy. Clin Obes. 2021 Apr;11(2):e12431. doi: 10.1111/cob.12431. Epub 2020 Nov 29.
- Derived from this study: PubMed 31409544Sockalingam S, Leung SE, Hawa R, Wnuk S, Parikh SV, Jackson T, Cassin SE. Telephone-based cognitive behavioural therapy for female patients 1-year post-bariatric surgery: A pilot study. Obes Res Clin Pract. 2019 Sep-Oct;13(5):499-504. doi: 10.1016/j.orcp.2019.07.003. Epub 2019 Aug 10.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly in order to protect patient confidentiality. Aggregate and anonymous data will be shared in peer-reviewed journal articles and scientific presentations.
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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.
Sanjeev Sockalingam, MD, FRCPC principal investigator
University of Toronto, Toronto Western Hospital
Stephanie E Cassin, PhD, CPsych principal investigator
Toronto Metropolitan University
Raed Hawa, MD, FRCPC study director
University of Toronto, Toronto Western Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone based Cognitive Behavioral Therapy in people with Obesity, run by University Health Network, Toronto at 1 site 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 5 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: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Eating Pathology: Emotional Eating Scale (EES) (time frame: Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention,). The study lists 4 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 NCT02920112, which also lists 5 linked publications.
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 2 May 2018.