Group CBT and Exercise in Management of Depression

NCT03731728 | Terminated DMC

• 1 other identifier: Pro00080975
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (7)

• Measuring changes in depressive symptoms scores using Beck Depression Inventory [Symptom Variable - Severity of Depression]

  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.

  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

• Evaluating change in symptoms using CORE 34 OM [Symptom variable - Symptoms Sub-scale - Psychological Health ]

  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.

  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

• Evaluating change in risk level using CORE 34 OM [Symptom variable - Risk Sub-scale - Psychological Health ]

  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.

  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

• Evaluating change in interpersonal functioning using CORE 34 OM [Functional variable - Functioning Sub-scale - Social Relationship ]

  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.

  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

• Evaluating change in well-being using CORE 34 OM [Functional variable - Well-being sub-scale - Psychological Health ]

  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.

  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

• Evaluating change in symptoms, risk level, interpersonal functioning, and well-being using CORE 10 OM [Symptom and Functional Variable - Psychological Health]

  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.

  At the 1st to 13th week of the 14-week intervention delivery period except week 7 when CORE 34 OM will be administered

• Change in the level of physical activity using the International Physical Activity Questionnaire [Functional Variable - Physical Activity]

  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.

  At the enrollment, at the 1st, 7th, and 14th week of the 14-week intervention delivery period

Secondary Outcomes (8)

• Evaluating patients satisfaction with the service using Addiction and Mental Health Client Experience Survey [Service variables - Satisfaction with service]

  7 and 14 weeks after commencing the intervention

• 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]

  7 and 14 weeks after commencing the intervention

• Number of emergency department presentations in the past 6 months - [Service Variable - Service Utilization]

  At the time of enrollment in the study and 6 months after enrollment

• Number of EMS use in the past 6 months - [Service Variable - Service Utilization]

  At the time of enrollment in the study and 6 months after enrollment

• Number of community Addiction and Mental Health services appointments completed in the past 6 months - [Service Variable - Service Utilization]

  At the time of enrollment in the study and 6 months after enrollment

Study Arms (3)

Group CBT plus TAU

EXPERIMENTAL

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

Group Exercise plus TAU

EXPERIMENTAL

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

Wait-listing for TAU

NO INTERVENTION

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.

Interventions

Group CBT BEHAVIORAL

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.

Group CBT plus TAU

Group exercise BEHAVIORAL

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.

Group Exercise plus TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have not provided informed consent
• Have a diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Royal Alexander Hospital

Edmonton, Alberta, T5H2V1, Canada

Location

Related Publications (12)

• Abdollahi A, LeBouthillier DM, Najafi M, Asmundson GJG, Hosseinian S, Shahidi S, Carlbring P, Kalhori A, Sadeghi H, Jalili M. Effect of exercise augmentation of cognitive behavioural therapy for the treatment of suicidal ideation and depression. J Affect Disord. 2017 Sep;219:58-63. doi: 10.1016/j.jad.2017.05.012. Epub 2017 May 8.

  PMID: 28525821 BACKGROUND

• Bridle C, Spanjers K, Patel S, Atherton NM, Lamb SE. Effect of exercise on depression severity in older people: systematic review and meta-analysis of randomised controlled trials. Br J Psychiatry. 2012 Sep;201(3):180-5. doi: 10.1192/bjp.bp.111.095174.

  PMID: 22945926 BACKGROUND

• Catalan-Matamoros D, Gomez-Conesa A, Stubbs B, Vancampfort D. Exercise improves depressive symptoms in older adults: An umbrella review of systematic reviews and meta-analyses. Psychiatry Res. 2016 Oct 30;244:202-9. doi: 10.1016/j.psychres.2016.07.028. Epub 2016 Jul 22.

  PMID: 27494042 BACKGROUND

• Cooney G, Dwan K, Mead G. Exercise for depression. JAMA. 2014 Jun 18;311(23):2432-3. doi: 10.1001/jama.2014.4930.

  PMID: 24938566 BACKGROUND

• Craft LL, Perna FM. The Benefits of Exercise for the Clinically Depressed. Prim Care Companion J Clin Psychiatry. 2004;6(3):104-111. doi: 10.4088/pcc.v06n0301.

  PMID: 15361924 BACKGROUND

• Euteneuer F, Dannehl K, Del Rey A, Engler H, Schedlowski M, Rief W. Immunological effects of behavioral activation with exercise in major depression: an exploratory randomized controlled trial. Transl Psychiatry. 2017 May 16;7(5):e1132. doi: 10.1038/tp.2017.76.

  PMID: 28509904 BACKGROUND

• Gill A, Womack R, Safranek S. Clinical Inquiries: Does exercise alleviate symptoms of depression? J Fam Pract. 2010 Sep;59(9):530-1.

  PMID: 20824231 BACKGROUND

• Huang TT, Liu CB, Tsai YH, Chin YF, Wong CH. Physical fitness exercise versus cognitive behavior therapy on reducing the depressive symptoms among community-dwelling elderly adults: A randomized controlled trial. Int J Nurs Stud. 2015 Oct;52(10):1542-52. doi: 10.1016/j.ijnurstu.2015.05.013. Epub 2015 Jun 10.

  PMID: 26105535 BACKGROUND

• Josefsson T, Lindwall M, Archer T. Physical exercise intervention in depressive disorders: meta-analysis and systematic review. Scand J Med Sci Sports. 2014 Apr;24(2):259-72. doi: 10.1111/sms.12050. Epub 2013 Jan 30.

  PMID: 23362828 BACKGROUND

• Mead GE, Morley W, Campbell P, Greig CA, McMurdo M, Lawlor DA. Exercise for depression. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD004366. doi: 10.1002/14651858.CD004366.pub4.

  PMID: 19588354 BACKGROUND

• Schuch FB, Vancampfort D, Richards J, Rosenbaum S, Ward PB, Stubbs B. Exercise as a treatment for depression: A meta-analysis adjusting for publication bias. J Psychiatr Res. 2016 Jun;77:42-51. doi: 10.1016/j.jpsychires.2016.02.023. Epub 2016 Mar 4.

  PMID: 26978184 BACKGROUND

• Yekrang Safakar M, Hrabok M, Urichuk L, Juhas M, Shalaby R, Parmar D, Chue P, Snaterse M, Mason J, Tchida D, Kelland J, Coulson P, Sosdjan D, Brown J, Hay K, Lesage D, Paulsen L, Delday A, Duiker S, Surood S, Abba-Aji A, Agyapong VIO. Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 May 25;9(5):e14309. doi: 10.2196/14309.

  PMID: 32449684 DERIVED

Related Links

• Depression and other common mental disorders: global health estimates.
• Depression in adults: recognition and management \| Guidance and guidelines \| NICE
• Edmonton, C. of. (2017, September 14). 2016 Municipal Census Results.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: November 6, 2018
• Study Start: April 15, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)