Mechanisms Of Change in Psychotherapy: The Effects of Cognitive Behavioral Therapy and Psychodynamic Therapy in Once - Versus Twice - Weekly Sessions on Outcomes in Depression.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
The MOP II study examines how to improve therapy for people struggling with a depressive disorder. Cognitive Behavioral Therapy (CBT) and Short-Term Psychodynamic Psychotherapy (STPP) are two evidence-based treatments for depression that are widely used. Meta-analyses indicate that CBT and STPP are one average equally effective and superior to no treatment. However, many patients do not respond sufficiently and relapse rates after acute phase treatment are high.
Earlier research and theoretical insights suggest three promising strategies to enhance the effectiveness of psychotherapy. First, we want to examine whether increasing the frequency of the sessions will increase the effect of therapy. We want to compare once-weekly and twice-weekly sessions in both CBT and STPP to see whether more frequent sessions lead to better and more lasting reductions in depressive symptoms with the same total number of sessions.
Second, the study aims to answer what works for whom in two different psychotherapeutic approaches. People with depression differ in personality, life experiences, relationship styles, and how they understand the causes of their depression. Previous findings suggest that patients do better when the therapy approach matches how they see their problems. The MOP II study wants to replicate this finding.
Third, the study wants to examine how therapy leads to change. In CBT, improvement is thought to happen through changes in thinking patterns, such as fewer negative automatic thoughts and less rumination. In STPP, change is expected to come from better self-understanding, greater emotional awareness, and healthier ways of relating to others.
Consequently, the goal of the MOP II study is to find out whether more frequent therapy, better matching of patients to treatment type, and a clearer understanding of how therapy works can lead to faster improvement of depressive symptoms.
详细描述
Major depressive disorder (MDD) leads to significant disability, mortality, and economic strain. It ranks fourth globally in terms of disease burden and is expected to rank first in high-income countries by 2030, highlighting an urgent need for effective treatments. Evidence-based psychotherapy methods and antidepressant medications are equally effective treatments. Cognitive Behavioral Therapy (CBT) and Short-Term Psychodynamic Psychotherapy (STPP) are two evidence-based treatments for depression that are widely used. Meta-analyses indicate that CBT and STPP are one average equally effective and superior to no treatment. However, many patients do not respond sufficiently and relapse rates after acute phase treatment are high, estimated at up to 40%.
The guidelines from the UK National Institute for Health and Care Excellence (NICE) underscore the importance of personalized care. They recommend various therapies, including CBT and STPP, tailored to individual needs and preferences of patients with both mild and severe depression. However, the empirical evidence supporting personalized care is limited and insufficient.
Earlier research and theoretical insights suggest two promising strategies to enhance the effectiveness of psychotherapy. First, increasing the frequency of therapy sessions may lead to better treatment outcomes. Second, conducting experimental studies that explore "what works for whom and how" may provide knowledge that can improve efficacy, raise the proportion of responders, and reduce relapse risk. Based on such research, tailoring interventions to individual needs can further optimize treatment success.
2. Background 2.1 Once versus twice weekly sessions of psychotherapy A meta-regression analysis by Cuijpers et al. found a strong association between session frequency and treatment effect size. Specifically, increasing the frequency from one to two sessions per week-while keeping the total number of sessions constant-led to a substantial increase in effect size (g = 0.45). These findings suggest that concentrating psychotherapy sessions within a shorter time frame may enhance treatment efficacy. However, as Cuijpers et al. (2013) concluded, more research is necessary to validate the robustness of these results. The optimal duration and intensity of psychotherapy remain unclear, and most previous studies have lacked controlled designs.
To our knowledge, only one randomized controlled trial (RCT) has directly compared the effects of once-weekly versus twice-weekly psychotherapy sessions. Bruijniks et al. conducted an RCT investigating whether patients with depression receiving twice-weekly sessions of cognitive behavioral therapy (CBT) or interpersonal therapy (IPT) showed greater symptom improvement than those receiving once-weekly sessions of the same therapies. The study found an effect size of 0.55 in favor of twice-weekly sessions. However, in a two-year follow-up study, Bruijniks et al. reported that while the differences persisted for up to nine months, no significant differences remained at the 24-month follow-up.
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
- Double (Investigator, Outcomes Assessor)
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
- •age 18-65 years
- •Major Depressive Disorder Hamilton Depression Rating Scale (HDRS) >
- •Speak and understand a Scandinavian language
- •Willingness and ability to give informed consent.
排除标准
- •Current or past neurological illness
- •Traumatic brain injury
- •Current alcohol and/or substance dependency disorders
- •Psychotic disorders
- •Bipolar disorders
- •Developmental disorders
研究组 & 干预措施
CBT once weekly
The patients in this arm will receive CBT once a week in 16 weeks plus three monthly boosters during 3 months
干预措施: Cognitive behavior therapy (Behavioral)
CBT twice weekly
The patients in this arm will receive CBT twice a week in 8 weeks plus three booster sessions every second week three times.
干预措施: Cognitive behavior therapy (Behavioral)
STPP once weekly
The patients in this arm will receive STPP once a week in 28 weeks.
干预措施: Psychodynamic therapy (Behavioral)
STPP twice weekly
The patients in this arm will receive STPP twice a week in 14 weeks.
干预措施: Psychodynamic therapy (Behavioral)
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS)
时间窗: From enrollment to the end of treatment at 28 weeks
Hamilton Depression Rating Scale (HDRS) is a clinician-rated questionnaire used to assess the severity of depressive symptoms. Higher total scores indicate more severe depression.
The Patient Health Questionnaire (PHQ-9)
时间窗: From baseline (enrollment) to end of treatment at 28 weeks
PHQ-9 is a 9-item scale that measures levels of depression. The PHQ-9 is a self assessment instrument and higher scores indicate more severe depressive symptoms
次要结局
- General Anxiety Disorder(From baseline to end of treatment at 28 weeks)
- The Work And Social Adjustment Scale (WSAS)(From enrollment to end of treatment at 28 weeks)
- The Personality Inventory for DSM-5-Brief Form (PID-5-BF)-Adult(From enrollment to end of treatment at 28 weeks)
- The Level of Personality Functioning Scale-Brief Form (LPFS-BF)(From enrollment to end of treatment at 28 weeks)
- The Self- Reflection and Insight Scale (SRIS)(From enrollment to end of treatment at 28 weeks)
- Defense Mechanisms Rating Scales-Self-Report-30 (DMRS-SR-30).(From enrollment to end of treatment at 28 weeks)
- Tolerance for Emotional Distress and Emotional Clarity (TED and EC) comprise 7 items that assess the patient's tolerance for distress and emotional clarity(From enrollment to end of therapy at 28 weeks)
- The Meta Cognitive Questionnaire (MCQ-30)(From enrollment to end of therapy at 28 weeks)
- Positive Beliefs about Rumination(PBRS)(From enrollment to end of therapy at 28 weeks)
- Dysfunctional Attitude Scale (DAS)(From enrollment to end of treatment at 28 weeks)
- Ruminative Response Scale (RRS)(From enrollment to end of therapy at 28 weeks)
- The Working Alliance Inventory (WAI-12-P)(From two weeks after enrollment and assessed at 8 weeks, 14 weeks and end of treatment 28 weeks)
- Bergen Insomnia Scale (BIS)(At enrollment and at end of treatment at 28 weeks)
- Insomnia Severity Index (ISI)(From enrollment and et end of treatment at 28 weeks)
- Pre Sleep Arousal Scale(From enrollment to end of treatment at 28 weeks)
- The Feeling Word Checklist (FWC-58)(From two weeks after enrollment to end of treatment at 28 weeks)
- The Working Alliance Inventory- Therapists (WAI-12-T) i(From two weeks after enrollment to end of therapy at 28 weeks)
- Hamilton Depression Rating Scale (HDRS)(From enrollment to 12 months follow-up)
- Hamilton Depression Rating Scale (HDRS)(From enrollment to 3 years follow up)
- Patient health Questionnaire (PHQ-9)(From baseline (enrollment) to 12 months follow up)
- Patient Health Questionnaire(From baseline to 3 years follow up)
- General Anxiety Disorder- 7 (GAD-7)(From baseline to one year follow up)
- General Anxiety Disorder- 7 (GAD-7)(From baseline to three years follow up)
- The Work And Social Adjustment Scale (WSAS)(From enrollment to one years follow up)
- The Work And Social Adjustment Scale (WSAS)(From enrollment to three years follow up)
- The Personality Inventory for DSM-5-Brief Form (PID-5-BF)-Adult(From enrollment to one year follow up)
- The Personality Inventory for DSM-5-Brief Form (PID-5-BF)-Adult(From enrollment to three years follow up)
- The Level of Personality Functioning Scale-Brief Form (LPFS-BF)(From enrollment to one year follow up)
- The Level of Personality Functioning Scale-Brief Form (LPFS-BF)(From enrollment to three years follow up)
- The Self- Reflection and Insight Scale (SRIS)(From enrollment to one year follow up)
- The Self- Reflection and Insight Scale (SRIS)(From enrollment to three years follow up)
- Defense Mechanisms Rating Scales-Self-Report-30 (DMRS-SR-30).(From enrollment to one year follow up)
- Defense Mechanisms Rating Scales-Self-Report-30 (DMRS-SR-30).(From enrollment to three years follow up)
- Tolerance for Emotional Distress and Emotional Clarity(From baseline to one year follow up)
- Tolerance for Emotional Distress and Emotional Clarity(From baseline to three years follow up)
- The Meta Cognitive Questionnaire (MCQ-30)(From enrollment to one year follow up)
- The Meta Cognitive Questionnaire (MCQ-30)(From enrollment to three years follow up)
- Positive Beliefs about Rumination(PBRS)(From enrollment to one year follow up)
- Positive Beliefs about Rumination(PBRS)(From enrollment to three years follow up)
- Dysfunctional Attitude Scale (DAS)(From enrollment to one year follow up)
- Dysfunctional Attitude Scale (DAS)(From enrollment to three years follow up)
- Ruminative Response Scale (RRS)(From enrollment to one year follow up)
- Ruminative Response Scale (RRS)(From enrollment to three years follow up)
- Bergen Insomnia Scale (BIS)(At enrollment and at one year follow up)
- Bergen Insomnia Scale (BIS)(At enrollment and at three years follow up)
- Insomnia Severity Index (ISI)(From enrollment to one year follow up)
- Insomnia Severity Index (ISI)(From enrollment and at three years follow up)
- Pre Sleep Arousal Scale(From enrollment to one year follow up)
- Pre Sleep Arousal Scale(From enrollment to three years follow up)
研究者
Jan Ivar Rossberg
Professor
Oslo University Hospital