The Effectiveness of Group CBT and Exercise in Management of Depression: A Three Arm Randomized Controlled Pilot Trial
Phase: NA
Conditions: Major Depressive Disorder
Sponsor: University of Alberta

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The effectiveness of group CBT and exercise in management of 
Major Depressive Disorder: Protocol for a randomized pilot trial 
 
Marianne Hrabok1, Mojtaba Y. Safakar1, Graham Gaine2, Liana Urichuk¹ʼ², Michal Juhas1, Reham Shalaby1, Pierre 
Chue1, Mark Snaterse2, Judith Mason2, Kristina Devoulyte2, Laura Leclair2, Donna Tchida2, Jill Kelland2, Pam 
Coulson2, Daniella Sosdjan2, Jeff Coulombe2, Jason Brown2, Katherine Hay2, Deanna Lesage2, Lucey Flichel2, Amy 
Delday2, Sherianna Duiker2, Shireen Surood2,3, Adam Abba-Aji1, Vincent I.O. Agyapong1 
 
1Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada 
2Addiction and Mental Health, Alberta Health Services, Edmonton, Alberta, Canada 
3Faculty of Social Work, University of Calgary, Calgary, AB, Canada 
 
*Corresponding author:  
Vincent Israel Opoku Agyapong  
Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta  
1E1 Walter Mackenzie Health Sciences Centre (WMC), 8440 112 St NW, Edmonton, AB T6G 2B7 Canada Phone: 
1 780 215 7771 Fax: 1 780 743 3896 Email: agyapong@ualberta.ca 
 
 
 
 
 
 
 
 
 
Source of support: This work was supported by a Pfizer Depression grant (via Department of 
Psychiatry, University of Alberta) and support was received from Alberta Health Services 
 
Word count: 2865 
 
Number of tables: 2 
Competing Interests Statement: All authors have nothing to disclose. 
 
 
 
 
 
 
Ethical clearance from Health Ethics Research Board of the University of Alberta, approved on 
2018-09-07 - Ref. # Pro 00080975 
Operational Approval from Alberta Health Services, approved on 2018-09-12 – Ref. AHS # 43638 
Trial registration number on ClinicalTrials.gov: NCT03731728; Pre-results 
 
Version: 2019-03-26 

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ABSTRACT 
Introduction: Despite evidence in scientific literature indicating the effectiveness of both 
Cognitive-Behavior Therapy (CBT) and physical exercise in the management of Major Depressive 
Disorder (MDD), few studies have directly compared them.   
Objective: This study will evaluate and compare the effectiveness of group CBT versus 
physical exercise versus only wait-listing to receive treatment as usual (TAU) in the management 
of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or 
exercise arms of the study will achieve superior outcomes compared to participants wait-listed to 
receive TAU only.  
Methods and analysis: This prospective rater-blinded randomized controlled trial assesses 
the benefits of group CBT and exercise for participants with MDD. 120 patients with MDD 
referred to Addiction and Mental Health clinics in Edmonton will be randomly assigned to one of 
the three equal-size arms of the study to receive either weekly sessions of group CBT plus TAU 
or group exercise 3 times a week plus TAU or only TAU for 14 weeks. Participants will be assessed 
at enrollment, three and six months post enrolment, mid-treatment, and at treatment completion 
for primary (functional and symptom variables) and secondary outcomes (service variables and 
healthcare utilization). In addition, participants in the intervention groups would 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 (Pro 00080975), operational 
approval from the provincial health authority (AHS 43638) and is registered with clinicaltrials.gov. 
The results will be disseminated at several levels, including patients, practitioners, 
academics/researchers, and healthcare organizations. 
Trial registration number on ClinicalTrials.gov: NCT03731728; Pre-results. 
 
Keywords: depression, Major Depressive Disorder, cognitive behavior therapy, group 
CBT, exercise.  
 
 
 
Strengths of this study 
 
• 
Randomization of participants will ensure that patients in the three treatment arms have 
fairly similar psychiatric morbidity at baseline 
• 
Blinding of outcome assessors and the use of self-rating scales for the primary outcome 
measures will ensure the elimination of bias in outcome measures.  
 
Limitation of this study 
• 
The rather small sample size may reduce the study power which will limit the ability of 
the study to detect differences in outcome measures between participants in the three 
treatment arms  
 

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INTRODUCTION 
 
Background and rationale 
Depressive disorders are a major public health problem. For example, the global prevalence 
of depressive disorders is over 4%, and depression is the single largest contributor to non-fatal 
health loss [1]. There is a need to identify interventions that are relatively cost-efficient, scalable, 
and can be offered to many people. Treatment for depressive disorders typically includes anti-
depressant medication and/or counselling and psychotherapy.  
Exercise as a form of treatment for depressive disorders, especially of mild-to-moderate 
severity, has evidence of benefit [2, 3, 4, 5]. In fact, the magnitude of the effect of exercise as a 
treatment for depression is reported to be comparable to conventional treatment [6, 7]. An umbrella 
review of systematic reviews and meta-analyses of the use of exercise to treat depressive 
symptoms in older adults, for example, concluded that “exercise is safe and efficacious in reducing 
depressive symptoms in older people” and exercise “should be considered as a core intervention 
in the multidisciplinary treatment of older adults experiencing depression” [8]. A meta-analysis 
adjusting for publication bias, concluded that “exercise has a large and significant antidepressant 
effect in people with depression” [9]. The mechanisms by which exercise decreases depressive 
symptoms may include biological mechanisms, such as anti-inflammatory effects [10] or 
increasing neurotransmitter levels implicated in depression [11]. Other mechanisms may include 
increase in self-efficacy [10] or enhanced social interaction [12]. 
Despite this strong evidence base, few studies have incorporated multiple treatment 
conditions in a randomized controlled trial design, and few studies appear to have assessed the 
effect of group CBT in comparison to exercise. A randomized clinical trial that assigned 54 mild 
to moderately depressed patients to a combined CBT plus exercise condition vs. a CBT only 
condition [13] found superior outcomes in suicidal ideation, depression, and activities of daily 
living in the combined condition compared to group CBT only. However, few studies could be 
found that compared group CBT, group exercise, and wait-listing for treatment as usual conditions.  
This is important in further delineating the effective components of treatment for mild to moderate 
depression, and results have implications for service delivery and clinical recommendations in the 
treatment of depression within healthcare organizations in Alberta and beyond. Specifically, 
patients with MDD referred to Addiction and Mental Health Clinics in Edmonton Zone may wait 
for weeks before receiving individual treatment. Thus, group treatment conditions examined in 
this study may serve as an expedient treatment avenue to decrease wait-list times for patients with 
MDD and improve outcomes. 
 
Aim and Objectives 
The aim of the project is to conduct a randomized pilot trial to evaluate the feasibility and 
effectiveness of group CBT and group exercise on depression symptom scores and functioning. 
The client outcomes will be organized according to: functional variables (relationships, well-being, 
physical activity), symptom variables (change in depressive symptoms scores), and service 
variables (patient compliance, retention in treatment, patient satisfaction).  
Given the aim, one objective of the project are to compare mean changes in functioning, 
clinical symptoms, and service satisfaction variables from enrolment baseline to 12 weeks post 
enrolment for: 
1) participants receiving group CBT plus wait-listed to receive TAU; 2) participants 
receiving scheduled exercise plus wait-listed to receive TAU; and 3) participants only wait-listed 
to receive TAU. Another objective of the study is to compare mean changes in functioning, clinical 

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symptoms, and service satisfaction variables from treatment baseline to 7 and 14 weeks post-
treatment commencement for: 1) participants receiving group CBT plus wait-listed to receive TAU 
and 2) participants  receiving scheduled exercise plus wait-listed to receive TAU. 
 
Hypothesis   
The investigators hypothesize that participants enrolled in the group CBT or group exercise 
treatments while wait-listed to receive TAU will achieve statistically superior outcomes  at 12 
weeks post enrollment compared to participants only wait-listed to receive TAU on each outcome 
measure used. We expect that participants enrolled in group CBT plus TAU will have comparable 
outcomes to those enrolled in the group exercise plus TAU arm of the study at 7and 14 weeks post 
treatment commencement.   
 
 
MATERIALS AND METHODS 
Overview of study design, timeline and participant selection 
This study will be a longitudinal, prospective, parallel design, three-arm, rater-blinded 
randomized clinical trial with a recruitment period of six months and an observation period of 14 
weeks (plus waiting time) for each participant. The study will be executed according to the 
timelines specified in the Gantt chart in Table1. 
The research will be carried out in a municipal recreational centre as well as Addiction and 
Mental Health clinics in Edmonton, a large, socio-demographically diverse city in Western Canada 
[14]. Potential participants will be recruited from the Addiction and Mental Health Intake Clinic 
in Edmonton. Patients with depression at intake assessment who are presumed to meet the 
inclusion criteria of the study will be invited to enroll.  
To confirm the diagnosis of MDD using DSM-5 criteria, potential participants will be sent 
to the Mood and Anxiety clinic or Urgent Clinics in Edmonton where they will be assessed by one 
of a group of psychiatrists or psychiatry residents who are independent from the study team. The 
psychiatrist or resident may or may not initiate, continue or adjust pharmacotherapy. The diagnosis 
will be communicated to the study coordinator and clinic nurse. The participants with MDD will 
be informed of their eligibility to participate in the study and will be considered for randomization 
after providing informed consent whereas patients with other diagnoses will be informed of their 
exclusion from the study and will be directed to receive an appropriate treatment for their 
condition. 
After diagnostic confirmation by a psychiatrist, a research assistant who is trained in study 
procedures will provide the potential participants with an information leaflet about the study and 
answer any related questions they may have. All potential participants who agree to take part in 
the study will provide written informed consent prior the completion of baseline assessment 
measures and randomization.  
Patients who are 18 to 65 years of age, have been referred by a primary care provider or 
self-referred to the Addiction and Mental Health Intake Clinic in Edmonton, have received a 
primary diagnosis of MDD from a consultant psychiatrist based on DSM-5 criteria, and have 
provided written informed consent will be included in the study. Patients will be ineligible if they 
do not meet the above inclusion criteria, have not provided informed consent, or have a diagnosis 
of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder.   

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At baseline, demographic and contact information will be collected. The participant’s name 
and contact information will be collected only for use in future communication or for arrangement 
of treatment, assessment and follow-up sessions.  
Participant's Medical Record will also be reviewed at two points, at enrolment and 6 
months after enrolment, to gather information about the participant's use of health services in the 
past 6 months and compare service utilization among the groups and determine if participation in 
the intervention groups impacts the use of other health services in the short term. This same data 
can also be used for any economic analyses (i.e., cost-effectiveness) that will be conducted. 
All the data will be stored for a minimum of 7 years prior to destruction as per the research ethics 
board requirements, and research ethics board requirements pertaining to collection and storage 
of information will be followed. 
 
 
 
 
 
 
 
 
 

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Table 1: Gantt chart for group CBT and exercise project 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Year 1 
Year 2  
 
 
Start Date-End Date 
Start Date-End Date 
Milestone No. 
Milestones 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Milestone 1:  Setting up of infrastructure for group CBT and gymnasium    
 
1.1  
Assembling of group CBT 
facilitators and setting of 
gymnasium in the community 
 
 
 
 
 
 
Milestone 2:  The recruitment of study participants 
2.1 
Recruitment, baseline assessment, 
randomization  
 
 
 
 
 
 
2.2 
Assignment into one of the three 
arms of the study 
 
 
 
 
 
 
 
2.3 
 
Delivery of group CBT, exercise, 
and/or TAU to participants  
 
 
 
 
 
 
Milestone 3:  Follow-up assessment of study participants 
 
 
3.1  
 
Follow-up assessments of 
individual study participants 
(Excluding satisfaction surveys) 
 
 
 
 
 
 
3.2 
Follow-up satisfaction survey of 
participants all groups 
 
 
 
 
 
 
Milestone 4: Data compilation, analysis and preparation of reports, publications and presentations 
 
4.1 
Data compilation 
 
 
 
 
 
 
 
 
4.2 
Data Analysis 
 
 
 
 
 
 
 
 
4.3 
Preparation of reports, publications 
and presentations 
 
 
 
 
 
 

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Interventions 
Participants enrolled in the group CBT plus TAU condition will be wait-listed to receive 
TAU and will receive a 2-hour session of group CBT every week for 14 weeks. 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. 
Participants in the TAU only arm of the study will be wait-listed to receive individual therapy or 
counselling from a therapist as per current standard protocol for managing patients with MDD in 
Addiction and Mental Health Clinics in Edmonton Zone. All above participants may or may not 
receive pharmacotherapy as prescribed by a psychiatrist who is independent from the study team. 
Group CBT: The group CBT will be offered in Addiction and Mental Health Clinics of 
Edmonton at 3 clinics: Edmonton Community Mental Health Clinic, Edmonton Hope and 
Wellness Centre, and AHS Clinical Psychology Service. All therapists will use a manualized CBT 
protocol with the same handouts and schedule developed based on the book “Mind Over Mood”. 
It 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 exercise: For scheduled group exercise, the research team will follow the current 
recommendations based on a literature review for the use of exercise for the treatment of 
depression, as well as Canadian Physical Activity Guide recommendations. Scheduled group 
exercises incorporate the following parameters: 
Type – aerobic or strength training exercises 
Dose – 3 times per week 
Intensity- moderate [participant self-rated physical activity of a 6 or 7on the Borg Perceived 
Exertion (BPE) scale of 10, relative to the individual’s personal capacity]. Moderate heart 
rate level will be calculated (65% to 75 % of maximum heart rate) for each participate at 
the beginning of the study and they will have access to heart rate monitors to gain an 
understanding of what moderate intensity feels like in their body  
Time –50 minutes in moderate heart rate zone) per session with 3 sessions per week (150 
minutes/week). 
Duration – 14 weeks 
Other - with supervision: Physical exercise sessions will be run by CanFit Pro or AFLCA 
certified Recreational Therapists who will assess safety of patients' involvement in physical 
activity using "Par-Q & You" questionnaire before initiation of the study and address any physical 
problems to minimize the risk of any adverse events happening during sessions. This form is a 
screening tool to determine safe participation in exercise. Participants identified as potentially at 
risk with physical activity will require clearance to participate by his/her medical doctor.  
Participants will have an opportunity to choose from a variety of physical activities in order 
to facilitate a meaningful physical activity experience which is important for long term 
maintenance. Participants will have the opportunity to engage in three of the following fitness 
programs per week for fourteen weeks: Monday: Individual fitness for 50 minutes; Tuesday: 
Group exercise or individual fitness for 50 minutes; Wednesday: Aqua/swimming for 50 minutes; 
Thursday: Walking track and group exercise for 50 minutes; Friday: Pole walking or hiking 
according the season for 50 minutes 
All participants must consent to participate in the study facilitated exercise groups to be 
considered in the study because supervision and guidance is required for safety and ensuring 

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consistent results. During the trial participants are encouraged to participate in the exercise options 
offered. If the participant engages in the exercise independently it will not be counted as one of 
their sessions. Once the trial is completed they will be supported to continue exercise options in 
the community. Participants will be provided with fitness passes and equipment as needed. It will 
be explained to the participant that although the expense of the equipment is subsidized by the 
study team to facilitate their participation, they do not have to participate because of this supportive 
act. They may keep the equipment should they decide to withdraw from the study at any point. 
For each session, two Recreation Therapists will provide programming to a maximum of 
20 participants. During the sessions the Recreation Therapists will provide participants with 
information regarding health, wellness, fitness training and understanding exertion levels within 
exercise. Participants will be encouraged to participate at a moderate level of perceived exertion 
for the best results (6 to 7 on a 10-point scale). While engaging in the exercise programs the 
participants will be self-reporting intensity using a rating of perceived exertion scale to the 
facilitators. Each participant must attend at least 75% of programs (32 sessions out of 42 sessions) 
during the 14-week period to be considered as having completed the program and for data analysis 
purposes. 
 
Sample Size 
As this is a pilot study, the research will utilize data that can be elicited from participants 
who can be enrolled within existing operational resources and time frames. The study will 
therefore be limited to a sample size of 120, with about 40 patients recruited into each arm of the 
study. 
 
Outcome Measures: 
Outcome measures are detailed in Table 2. Primary outcomes include functional variables 
(relationships, well-being, physical activity) and symptom variables (depression, risk). Secondary 
client outcomes include service variables (satisfaction, health utilization).   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 2 Outcome Measures 
Construct 
Tool 
Rater 
Time 
Required 
Time Points Assessed 
At 
Enrollment 
At 
Start of 
group CBT 
or Exercise  
12 weeks  
Post 
enrolment 
Weekly* 
during 
group CBT 
or 
Exercise  
7weeks 
after start 
of  
group CBT 
or 
Exercise 
14weeks 
after start 
of  
group 
CBT or 
Exercise 
6 months 
after 
enrollment 
Symptom 
Variables 
Depressive 
symptoms 
Beck 
Depression 
Inventory 
(BDI-II) [15] 
Client 
5 min 
X 
X 
X 
 
X 
X 
X 
Symptoms, 
risk level 
CORE OM 
(Symptoms 
and Risk 
subscales) 
Client 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
Functional 
variables 
Inter- personal 
functioning 
 
  
CORE OM 
(Functionin
g subscale) 
Client 
10 min 
for 34-
items of 
CORE 
OM 
Well-being 
CORE OM 
(Well-being 
subscale) 
 
Client 
 
Physical 
Activity 
Internationa
l Physical 
Activity 
Questionnai
re 
Client 
5 min 
 
X 
 
 
X 
  
 
X 
X 
 
Symptom 
and 
functional 
variables  
Symptoms, 
risk, 
interpersonal 
functioning 
and wellbeing  
 
CORE-10 
OM 
 
Client  
 
5 min 
 
 
 
 
X 
 
 
 
Service 
variables 
 
  
Patient 
Satisfaction 
with Service 
Addiction 
and Mental 
Health 
Client 
Experience 
Survey 
Client 
5 min 
 
 
X 
X 
 
  
 
Health 
Utilization 
Data 
extraction 
Research 
Team 
- 
X 
 
 
X 
Total Time for 
participant 
 
 
20 min 
 
25 min 
25 min 
  
  
  
  
  
  
  
  
 
*Except week 7 and 14 when CORE 34 OM will be administered  
 
 
 
 
 
 
 

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Randomization and Blinding 
Randomization will be enacted via randomly generated codes. Each study participant will 
receive a randomization code. Because it will not be possible for participants to be blinded, 
treatment allocation will be made explicit to them as soon as randomization is concluded. 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 that contains the randomization 
code. In addition, study participants will self-complete all outcome assessments with the assessor 
facilitating procedural aspects if needed. Moreover, these assessors will not be involved in data 
analysis. After data collection is complete all data will undergo a blind review for the purposes of 
finalizing the planned analysis.  
 
Follow-up Assessment 
12 and 24 weeks after baseline assessments, a blinded researcher will contact study 
participants in all three arms of the study and assist them in the completion of a range of assessment 
tools related to the outcome measures. The number of treatment sessions (group CBT, group 
exercise or individual therapy) participants have received at each time point would be recorded for 
participants in all treatment arms. In addition, participants in the group CBT and exercise arms of 
the study would complete assessments tools weekly during the sessions and also at mid-treatment 
(7 weeks after starting treatment) and at the end of the treatment (14 weeks after the treatment 
commencement). These self-rated assessments would be coordinated by the group facilitators.  
 
Statistical Methods 
The primary goal of the statistical analysis will be to produce summary descriptive statistics 
for the longitudinal data, which will provide estimates for future sample size calculations and 
enable calculation of effect size. For the three arm trial, we will compare mean change scores for 
primary and secondary outcome measures from enrolment baseline to 12 weeks and 24 weeks 
post-enrolment into the study, whilst for the two arm trial, we will compare mean changes scores 
for primary and secondary outcome measures from treatment baseline to 7 and 14 weeks post-
enrolment into treatment in addition to comparing trends in weekly change scores on the CORE-
10 OM between the two intervention groups. The data will be analyzed using repeated measures 
and effect size analyses, and correlational analyses will be completed between measures at each 
time point. The results of this study will guide the design for a future, more highly powered, study. 
 
Patient and public involvement 
The study was designed and finalized based on feedback from patient representatives. This 
randomized trial also offers patients the opportunity to provide feedback via the patient satisfaction 
survey. 
 
 
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 participant. The study has received ethical clearance from Health Ethics 
Research Board of the University of Alberta (Ref. # Pro 00080975) and operational approval from 
the regional health authority (AHS # 43638). The study is registered with clinicaltrials.gov: 

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(registration number NCT03731728; pre-result). The results will be disseminated at several levels, 
including patients, practitioners, academics/researchers, and healthcare organizations.  
The investigators team will plan an organizational engagement strategy to advance 
discussions about feasibility and effectiveness prior to the conclusion of the trial. This will help 
ensure the findings are a relevant part of decision-making processes in a way that is aligned with 
study findings as they emerge. This may facilitate planning of a larger study that is endorsed at 
both leadership and operational levels, so that the potential benefits of the interventions can reach 
patients in a more timely fashion. 
 
 
DISCUSSION 
The results of the study will provide important information about the effectiveness of group 
CBT and/or group exercise in treatment of MDD. This will augment the literature in this area, and 
also provide practical benefits in examining if benefit can be derived from the addition group 
treatment modalities to TAU. Currently, patients with MDD referred to Addiction and Mental 
Health Clinics in Edmonton Zone may wait for weeks before receiving care from a health care 
professional in a one-to-one setting. Long wait may negatively impact patients’ well-being, 
personal and occupational function as well as their satisfaction with care, and a group-based 
treatment may serve as an alternative for patients with MDD that can be more expediently 
accessed.  
The results of the pilot trial may inform the implementation of a multi-center clinical trial 
and provide useful information for administrators and clinicians who are interested in 
incorporating these interventions into existing care.  The investigators expect that the pilot findings 
will inform and support administrative decision-making with respect to further scaling and 
studying the intervention within the province of Alberta and beyond.  
 
 
Authors’ Contributions: The study was conceived and designed by VIOA who also contributed 
to drafting of the initial and final drafts of the manuscript. MH, MYS, GG and LU contributed to 
the study design and drafting of the initial and final drafts of the manuscript. PC, MS, JM, KD, 
LL, DT, JK, PC, DS, JC, JB, KH, DL, LF, AD, SD SS and AAA contributed to the study design 
and revising the initial draft of the of the manuscript. All authors approved of the final draft of the 
manuscript prior to submission.  
 
Acknowledgment: The study team thank Cathy McAlear for her initial contribution to the exercise 
component of the trial design  
 
Funding Statement: This work was supported by a Pfizer Depression grant (via Department of 
Psychiatry, University of Alberta) and support was received from Alberta Health Services. 
Competing Interests Statement: All authors have nothing to disclose. 
 
 
 
 
 

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