The Effectiveness of Group CBT and Exercise in Management of Depression: A Three Arm Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Measuring changes in depressive symptoms scores using Beck Depression Inventory [Symptom Variable - Severity of Depression]
研究概览
简要总结
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.
详细描述
BACKGROUND AND RATIONALE: Depression with a global prevalence of over 4% is a major public health problem and is the single largest contributor to non-fatal health loss. 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. In fact, the magnitude of the effect of exercise as a treatment for depression is reported to be comparable to conventional treatment. 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 it should be considered as a core intervention in the multidisciplinary treatment of depression in this age group. A meta-analysis adjusting for publication bias, concluded that "exercise has a large and significant antidepressant effect in people with depression". The mechanisms by which exercise decreases depressive symptoms may include biological mechanisms, such as anti-inflammatory effects or increasing neurotransmitter levels implicated in depression. Other mechanisms may include increasing self-efficacy or enhancing social interaction.
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 addition, 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 (AMH) Clinics in Edmonton Zone may wait for weeks before receiving individual treatment. Thus, if found to be effective, group treatment conditions examined in this study may serve as an expedient treatment avenue to decrease wait-list times for patients with MDD.
AIM AND OBJECTIVES: The aim of the project is to conduct a three-arm randomized controlled pilot trial to evaluate the feasibility and initial efficacy of group CBT or group exercise on depression symptom scores and quality of life measures in patients with MDD. 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 (e.g. patient compliance and retention in treatment and patient satisfaction).
Given the aim, the objectives 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) those only wait-listed to receive TAU. Another objective of the study is to compare mean changes in functioning, clinical 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not meeting the above Inclusion Criteria
- •Have not provided informed consent
- •Have a diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder
研究组 & 干预措施
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.
干预措施: Group CBT (Behavioral)
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.
干预措施: Group exercise (Behavioral)
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.
结局指标
主要结局
Measuring changes in depressive symptoms scores using Beck Depression Inventory [Symptom Variable - Severity of Depression]
时间窗: 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.
Evaluating change in risk level using CORE 34 OM [Symptom variable - Risk Sub-scale - Psychological Health ]
时间窗: 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.
Evaluating change in symptoms using CORE 34 OM [Symptom variable - Symptoms Sub-scale - Psychological Health ]
时间窗: 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.
Evaluating change in symptoms, risk level, interpersonal functioning, and well-being using CORE 10 OM [Symptom and Functional Variable - Psychological Health]
时间窗: 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.
Evaluating change in interpersonal functioning using CORE 34 OM [Functional variable - Functioning Sub-scale - Social Relationship ]
时间窗: 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.
Evaluating change in well-being using CORE 34 OM [Functional variable - Well-being sub-scale - Psychological Health ]
时间窗: 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.
Change in the level of physical activity using the International Physical Activity Questionnaire [Functional Variable - Physical Activity]
时间窗: 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.
次要结局
- 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 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)
- 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)
- 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 calls to Crisis and urgent services in the past 6 months - [Service Variable - Service Utilization](At the time of enrollment in the study and 6 months after enrollment)
- Number of days stayed in inpatient services in the past 6 months - [Service Variable - Service Utilization](At the time of enrollment in the study and 6 months after enrollment)
- Social Return on Investment (SROI) of the initiative to the system in the past 6 months - [Service Variable - Service Utilization](At the time of enrollment in the study and 6 months after enrollment)