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Group CBT and Exercise in Management of Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731728
Recruitment Status : Terminated (COVID-19)
First Posted : November 6, 2018
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

INTRODUCTION: There is strong evidence indicating the effectiveness of Cognitive-Behavior Therapy (CBT) in the management of Major Depressive Disorder (MDD) and some clinical trials indicating physical exercise (PE) as an effective treatment for the disorder. However, few studies have evaluated the effect of group CBT or PE compared to wait-listing to receive treatment as usual (TAU) in the management of MDD. This study will evaluate and compare the effectiveness of: 1) group CBT plus wait-listing for TAU; versus 2) group PE plus wait-listing for TAU; versus 3) only wait-listing for TAU in management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or PE (plus wait-listed for TAU) arms of the study will achieve superior outcomes compared to participants only wait-listed for TAU.

METHODS AND ANALYSIS: This is a prospective rater-blinded randomized controlled trial assessing the benefits for participants with MDD. 120 patients with MDD referred to Addiction and Mental Health (AMH) clinics in Edmonton Zone who are informed about the study and consent to participate will be randomly assigned to one of the 3 arms of the study: 1) 40 participants wait-listed for TAU will receive weekly sessions of group CBT for 14 weeks; 2) 40 participants wait-listed for TAU will receive PE 3 times a week for 14 weeks; and 3) 40 participants will only be wait-listed for TAU. Participants will be assessed at enrollment, 3 and 6 months post enrolment, mid-treatment, and at treatment completion . Their assessments will cover primary outcomes including functional variables (relationships, well-being, physical activity) and symptom variables (changes in depressive symptoms scores). Secondary client outcomes will be service variables (e.g. patient compliance, retention in treatment, patient satisfaction). In addition, participants in the intervention groups will be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point.

ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong Amendment) and Good Clinical Practice (Canadian Guidelines). Written informed consent will be obtained from each subject. The study has received ethical clearance from Health Ethics Research Board of the University of Alberta (Ref. # Pro 00080975) and operational approval from the provincial health authority (AHS # 43638). The results will be disseminated at several levels, including patients, practitioners, academics/researchers, and healthcare organizations.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Group CBT Behavioral: Group exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be blinded to treatment group allocation by not involving them in discussions about study participants and not granting them access to the database which contains the randomization code. In addition, study participants will self-complete all outcome assessments on a tablet with the assessor only guiding the process. Moreover, these assessors will not be involved in data analysis.
Primary Purpose: Treatment
Official Title: The Effectiveness of Group CBT and Exercise in Management of Depression: A Three Arm Randomized Controlled Pilot Trial
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group CBT plus TAU
Participants enrolled in the "group CBT plus TAU" arm of the study will receive a 2-hour session of group CBT every week for 14 weeks in addition to being wait-listed to receive treatment as usual.
Behavioral: Group CBT
All therapists will use a manualized Cognitive-Behavior Therapy (CBT) protocol with the same handouts and schedule developed based on the book "Mind Over Mood". Group CBT will be provided to a group of maximum 10 participants. Each session will be 2 hours long and will be provided by certified therapists with special training to deliver group CBT. The structure of the session will be agenda setting, check-in, review of homework, new concepts/skills, homework assignment, and feedback.

Experimental: Group Exercise plus TAU
Participants enrolled in the "group exercise plus TAU" arm of the study will receive 50 minutes of scheduled and facilitated exercises three times a week for 14 weeks in addition to being wait-listed to receive treatment as usual.
Behavioral: Group exercise
Participants enrolled in the group exercise plus TAU arm of the study will be wait-listed for TAU and will receive 50 minutes of scheduled and facilitated exercises three times a week for 14 weeks.

No Intervention: Wait-listing for TAU
Participants enrolled in the wait-listing for "treatment as usual" or TAU arm of the study will be wait-listed to receive individual therapy or counselling from an Addiction and Mental Health therapist as per current standard protocol for managing patients with MDD at Addiction and Mental Health Clinics of Edmonton Zone.



Primary Outcome Measures :
  1. Measuring changes in depressive symptoms scores using Beck Depression Inventory [Symptom Variable - Severity of Depression] [ Time Frame: At the enrollment, at the weeks 12 and 24 post enrollment, at the 1st, 7th and 14th week of the 14-week intervention delivery period ]
    The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. It contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used are as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.

  2. Evaluating change in symptoms using CORE 34 OM [Symptom variable - Symptoms Sub-scale - Psychological Health ] [ Time Frame: At the enrollment, at the weeks 12 and 24 post enrollment, at the 1st, 7th and 14th week of the 14-week intervention delivery period ]
    This is a client self-report questionnaire designed to be administered before and after therapy. The client is asked to respond to 34 questions about how they have been feeling over the last week, using a 5-point scale ranging from 'not at all' to 'most or all of the time'. The questionnaire covers four dimensions: subjective well-being, problems/symptoms, life functioning and risk/harm. Key points in the scoring are as follows: each item within the CORE Outcome Measure is scored on a 5-point scale ranging from 0 (not at all) to 4 (most or all the time). The total score is calculated by adding the response values of all 34 items. The minimum score that can be achieved is 0 and the maximum 136. The total mean score is calculated by dividing the total score by the number of completed item responses. Symptoms sub-scale includes 12 items with a total score range of 0 to 48 and mean score range of 0 to 4 with a cut-off point of 1.44 for males and 1.62 for females.

  3. Evaluating change in risk level using CORE 34 OM [Symptom variable - Risk Sub-scale - Psychological Health ] [ Time Frame: At the enrollment, at the weeks 12 and 24 post enrollment, at the 1st, 7th and 14th week of the 14-week intervention delivery period ]
    This is a client self-report questionnaire designed to be administered before and after therapy. The client is asked to respond to 34 questions about how they have been feeling over the last week, using a 5-point scale ranging from 'not at all' to 'most or all of the time'. The questionnaire covers four dimensions: subjective well-being, problems/symptoms, life functioning and risk/harm. Key points in the scoring are as follows: each item within the CORE Outcome Measure is scored on a 5-point scale ranging from 0 (not at all) to 4 (most or all the time). The total score is calculated by adding the response values of all 34 items. The minimum score that can be achieved is 0 and the maximum 136. The total mean score is calculated by dividing the total score by the number of completed item responses. Risk sub-scale includes 6 items with a total score range of 0 to 24 and mean score range of 0 to 4 with a cut-off point of 0.43 for males and 0.31 for females.

  4. Evaluating change in interpersonal functioning using CORE 34 OM [Functional variable - Functioning Sub-scale - Social Relationship ] [ Time Frame: At the enrollment, at the weeks 12 and 24 post enrollment, at the 1st, 7th and 14th week of the 14-week intervention delivery period ]
    This is a client self-report questionnaire designed to be administered before and after therapy. The client is asked to respond to 34 questions about how they have been feeling over the last week, using a 5-point scale ranging from 'not at all' to 'most or all of the time'. The questionnaire covers four dimensions: subjective well-being, problems/symptoms, life functioning and risk/harm. Key points in the scoring are as follows: each item within the CORE Outcome Measure is scored on a 5-point scale ranging from 0 (not at all) to 4 (most or all the time). The total score is calculated by adding the response values of all 34 items. The minimum score that can be achieved is 0 and the maximum 136. The total mean score is calculated by dividing the total score by the number of completed item responses. Life/ interpersonal functioning sub-scale includes 12 items with a total score range of 0 to 48 and mean score range of 0 to 4 with a cut-off point of 1.29 for males and 1.30 for females.

  5. Evaluating change in well-being using CORE 34 OM [Functional variable - Well-being sub-scale - Psychological Health ] [ Time Frame: At the enrollment, at the weeks 12 and 24 post enrollment, at the 1st, 7th and 14th week of the 14-week intervention delivery period ]
    This is a client self-report questionnaire designed to be administered before and after therapy. The client is asked to respond to 34 questions about how they have been feeling over the last week, using a 5-point scale ranging from 'not at all' to 'most or all of the time'. The questionnaire covers four dimensions: subjective well-being, problems/symptoms, life functioning and risk/harm. Key points in the scoring are as follows: each item within the CORE Outcome Measure is scored on a 5-point scale ranging from 0 (not at all) to 4 (most or all the time). The total score is calculated by adding the response values of all 34 items. The minimum score that can be achieved is 0 and the maximum 136. The total mean score is calculated by dividing the total score by the number of completed item responses. Well-being sub-scale includes 12 items with a total score range of 0 to 48 and mean score range of 0 to 4 with a cut-off point of 1.37 for males and 1.77 for females.

  6. Evaluating change in symptoms, risk level, interpersonal functioning, and well-being using CORE 10 OM [Symptom and Functional Variable - Psychological Health] [ Time Frame: At the 1st to 13th week of the 14-week intervention delivery period except week 7 when CORE 34 OM will be administered ]
    This is a client self-report questionnaire designed to be administered before and after therapy. The client is asked to respond to 10 questions about how they have been feeling over the last week. The questionnaire covers four dimensions: subjective well-being, problems/symptoms, life functioning and risk/harm. Key points in the scoring of the CORE-10 are as follows: Each item is scored on a 5-point scale ranging from 0 ('not at all') to 4 ('most or all the time'). The clinical score is calculated by adding the response values of all 10 items and ranges from 0 to 40. The higher the score the more problems the individual is reporting and/or the more distressed they are. A score of 10 or below denotes a score within the non-clinical range and of 11 or above within the clinical range. Within the clinical range the score of 11 is the lower boundary of the 'mild' level, 15 for the 'moderate' level, and 20 for the 'moderate-to-severe' level. A score of 25 or over marks the 'severe' level.

  7. Change in the level of physical activity using the International Physical Activity Questionnaire [Functional Variable - Physical Activity] [ Time Frame: At the enrollment, at the 1st, 7th, and 14th week of the 14-week intervention delivery period ]
    IPAQ is a self-administered instrument designed for surveillance of physical activity in 15-69 years old adults. It consists of 6 questions and assesses physical activity undertaken across a comprehensive set of domains including walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of physical activity. Volume of activity can be computed by weighting each type of activity by its energy requirements defined in METs to yield a score in MET-minutes. METs are multiples of the resting metabolic rate and a MET-minute is computed by multiplying the MET score of an activity by the minutes performed. MET-minute scores are equivalent to kilocalories for a 60 kilogram person. Kilocalories may be computed from MET-minutes using the following equation: MET-min x (weight in kilograms/60 kilograms). MET-minutes/week will be reported.


Secondary Outcome Measures :
  1. Evaluating patients satisfaction with the service using Addiction and Mental Health Client Experience Survey [Service variables - Satisfaction with service] [ Time Frame: 7 and 14 weeks after commencing the intervention ]
    The "Addiction and Mental Health Client Experience Survey" is a 25-item self-administered tool gathering client's feedback on their experience with the following domains: 1) intake services, 2) information, communication and education, 3) respecting values, needs and preferences, 4) care plan, 5) coordinating and integrating services, 6) treatment effectiveness, asking them to rate their overall satisfaction with the service (item 22) on a scale of 0 to 10 where 0 stands for "not at all satisfied" and 10 stands for "very satisfied".

  2. Evaluating patients satisfaction with the care and treatment they received using Addiction and Mental Health Client Experience Survey [Service variables - Satisfaction with care and treatment] [ Time Frame: 7 and 14 weeks after commencing the intervention ]
    The "Addiction and Mental Health Client Experience Survey" is a 25-item self-administered tool gathering client's feedback on their experience with the following domains: 1) intake services, 2) information, communication and education, 3) respecting values, needs and preferences, 4) care plan, 5) coordinating and integrating services, 6) treatment effectiveness, asking them to rate the care and treatment they received (item 23) in a scale of 0 to 10 where 0 stands for "worst possible care" and 10 stands for "best possible care".

  3. Number of emergency department presentations in the past 6 months - [Service Variable - Service Utilization] [ Time Frame: At the time of enrollment in the study and 6 months after enrollment ]

    Participant's medical record will be reviewed at two points, at the time of enrollment in the study and 6 months after enrollment, to gather information about their use of health services in the past 6 months. The following data will be extracted: number of emergency department presentations, number of EMS use, number of community Addiction and Mental Health services appointments completed, number of days stayed in inpatient services, number of calls to Crisis and urgent services.

    The aim is to compare pre-post rates within each study arm cohort. Each variable would be analyzed separately to determine differences from pre-study to post-study within each cohort. These data will also be used to determine the probable Social Return on Investment (SROI) of the initiative to the system by showing cost-savings through a decrease/avoidance of service utilization. It will be done by assigning a monetary value to each variable. These values are already endorsed and available.


  4. Number of EMS use in the past 6 months - [Service Variable - Service Utilization] [ Time Frame: At the time of enrollment in the study and 6 months after enrollment ]

    Participant's medical record will be reviewed at two points, at the time of enrollment in the study and 6 months after enrollment, to gather information about their use of health services in the past 6 months. The following data will be extracted: number of emergency department presentations, number of EMS use, number of community Addiction and Mental Health services appointments completed, number of days stayed in inpatient services, number of calls to Crisis and urgent services.

    The aim is to compare pre-post rates within each study arm cohort. Each variable would be analyzed separately to determine differences from pre-study to post-study within each cohort. These data will also be used to determine the probable Social Return on Investment (SROI) of the initiative to the system by showing cost-savings through a decrease/avoidance of service utilization. It will be done by assigning a monetary value to each variable. These values are already endorsed and available.


  5. Number of community Addiction and Mental Health services appointments completed in the past 6 months - [Service Variable - Service Utilization] [ Time Frame: At the time of enrollment in the study and 6 months after enrollment ]

    Participant's medical record will be reviewed at two points, at the time of enrollment in the study and 6 months after enrollment, to gather information about their use of health services in the past 6 months. The following data will be extracted: number of emergency department presentations, number of EMS use, number of community Addiction and Mental Health services appointments completed, number of days stayed in inpatient services, number of calls to Crisis and urgent services.

    The aim is to compare pre-post rates within each study arm cohort. Each variable would be analyzed separately to determine differences from pre-study to post-study within each cohort. These data will also be used to determine the probable Social Return on Investment (SROI) of the initiative to the system by showing cost-savings through a decrease/avoidance of service utilization. It will be done by assigning a monetary value to each variable. These values are already endorsed and available.


  6. Number of days stayed in inpatient services in the past 6 months - [Service Variable - Service Utilization] [ Time Frame: At the time of enrollment in the study and 6 months after enrollment ]

    Participant's medical record will be reviewed at two points, at the time of enrollment in the study and 6 months after enrollment, to gather information about their use of health services in the past 6 months. The following data will be extracted: number of emergency department presentations, number of EMS use, number of community Addiction and Mental Health services appointments completed, number of days stayed in inpatient services, number of calls to Crisis and urgent services.

    The aim is to compare pre-post rates within each study arm cohort. Each variable would be analyzed separately to determine differences from pre-study to post-study within each cohort. These data will also be used to determine the probable Social Return on Investment (SROI) of the initiative to the system by showing cost-savings through a decrease/avoidance of service utilization. It will be done by assigning a monetary value to each variable. These values are already endorsed and available.


  7. Number of calls to Crisis and urgent services in the past 6 months - [Service Variable - Service Utilization] [ Time Frame: At the time of enrollment in the study and 6 months after enrollment ]

    Participant's medical record will be reviewed at two points, at the time of enrollment in the study and 6 months after enrollment, to gather information about their use of health services in the past 6 months. The following data will be extracted: number of emergency department presentations, number of EMS use, number of community Addiction and Mental Health services appointments completed, number of days stayed in inpatient services, number of calls to Crisis and urgent services.

    The aim is to compare pre-post rates within each study arm cohort. Each variable would be analyzed separately to determine differences from pre-study to post-study within each cohort. These data will also be used to determine the probable Social Return on Investment (SROI) of the initiative to the system by showing cost-savings through a decrease/avoidance of service utilization. It will be done by assigning a monetary value to each variable. These values are already endorsed and available.


  8. Social Return on Investment (SROI) of the initiative to the system in the past 6 months - [Service Variable - Service Utilization] [ Time Frame: At the time of enrollment in the study and 6 months after enrollment ]

    Participant's medical record will be reviewed at two points, at the time of enrollment in the study and 6 months after enrollment, to gather information about their use of health services in the past 6 months. The following data will be extracted: number of emergency department presentations, number of EMS use, number of community Addiction and Mental Health services appointments completed, number of days stayed in inpatient services, number of calls to Crisis and urgent services.

    The aim is to compare pre-post rates within each study arm cohort. Each variable would be analyzed separately to determine differences from pre-study to post-study within each cohort. These data will also be used to determine the probable Social Return on Investment (SROI) of the initiative to the system by showing cost-savings through a decrease/avoidance of service utilization. It will be done by assigning a monetary value to each variable. These values are already endorsed and available.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been referred by a primary care provider or self-referred to the Addiction and Mental Health intake service in Edmonton
  • Have received a diagnosis of Major Depressive Disorder from a consultant psychiatrist based on DSM 5 criteria
  • Have provided written informed consent

Exclusion Criteria:

  • Not meeting the above Inclusion Criteria
  • Have not provided informed consent
  • Have a diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731728


Locations
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Canada, Alberta
Royal Alexander Hospital
Edmonton, Alberta, Canada, T5H2V1
Sponsors and Collaborators
University of Alberta
Alberta Health Services
  Study Documents (Full-Text)

Documents provided by University of Alberta:
Study Protocol  [PDF] March 26, 2019
Informed Consent Form  [PDF] March 26, 2019

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03731728    
Other Study ID Numbers: Pro00080975
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders