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Completed

NCT Number: NCT02920112

Tele-CBT 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital with the University Health Network

Toronto, Ontario, M5T 2S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Active suicidal ideation.
  • Active serious mental illness
  • Active severe depression
  • Active severe anxiety
  • Active symptoms of post-traumatic stress disorder

Treatment and study plan

Telephone Based Cognitive Behavioral Therapy

Behavioral

6 sessions of Telephone based Cognitive Behavioral Therapy over the telephone, lasting approximately 60 minutes each.

Other names: Tele-CBT

Primary outcomes

  1. 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.

  2. Changes in Eating Pathology: Binge Eating Scale (BES)

    Time frame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

  3. 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.

  4. 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.

Secondary outcomes

  1. Satisfaction with Therapy: Working Alliance Inventory - Short Form (WAI-SF)

    Time frame: Weekly up to 6 weeks during intervention and immediately post-intervention

    12-item self-report measure that assesses the alliance between patient and therapist.

  2. Changes in Depression Severity

    Time frame: Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention

    Measured with Patient Health Questionnaire (PHQ-9), a 9-item self-report measure of depression severity.

  3. Changes in Anxiety Severity

    Time frame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

    Measured with Generalized Anxiety Disorder Questionnaire (GAD-7), a 7-item self-report measure of anxiety severity.

  4. Changes in Health-Related Quality of Life

    Time frame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

    Measured with Short-Form Health Survey (SF-36), a 36-item self-report measure of health-related quality of life.

  5. Satisfaction with Therapy: Tele-CBT Client Change Interview

    Time frame: Weekly up to 6 weeks during intervention, immediately post-intervention, 1 year after intervention

    a 9-item self-report measure that qualitatively assesses patient experience with the Tele-CBT treatment

  6. Satisfaction with Therapy: Helpful Aspects of Therapy Form (HAT)

    Time frame: Weekly up to 6 weeks during intervention and immediately post-intervention

    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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Telephone-Based Cognitive Behavioural Therapy for Bariatric Surgery Patients One Year Following Bariatric Surgery: A Pilot Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Sep 30, 2016
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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