Combining Treatment Components in Transdiagnostic Therapy for Anxiety and Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Depressive symptoms (PHQ-9)
研究概览
简要总结
The present study is a randomized controlled trial that will evaluate the effect of combining two treatment components (i.e., cognitive restructuring and detached mindfulness) drawn from cognitive behavioral therapies (CBTs) that are often combined in clinical practice. However, knowledge about the effect of combining these treatment components is lacking. Therefore, this study aims to explore single, combined, and sequencing effects of these two treatment components in patients with depression and/or anxiety disorders. Furthermore, the study aims to explore possible demographic and clinical moderators of the effects to address the question of what works for whom.
详细描述
A relatively large proportion of psychotherapists endorse practicing eclectic or integrative therapy, drawing from different schools of therapy (Norcross & Alexander, 2019). This tendency towards integrative therapy has been expressed by former president of the Association of Cognitive and Behavioral Therapies, J. B. Persons, who writes: "We [clinicians] rarely proceed through a single protocol from beginning to end. Instead, we use what might be called a mix-and-match strategy, in which we select interventions or modules from one or even two or more protocols that we believe will be helpful to the patient" (Persons, 2005, p. 107). Indeed, there has been a growing research and clinical interest in personalized therapy where treatment components from different therapies are combined with the aim of targeting the symptomatology and theorized maintenance processes of the individual patient (Cohen et al., 2021; DeRubeis et al., 2014; Fisher et al., 2019; Fisher & Boswell, 2016; Hayes et al., 2022; Huibers et al., 2021; Sauer-Zavala et al., 2022). In addition to this, an increasing number of therapies are designed by combining components from different treatment models (e.g., modular and process-based therapies; Barlow et al., 2018; Hofmann & Hayes, 2019; Hofmann et al., 2021). As a result, patients are likely to be the recipients of several different techniques or strategies, based on different theoretical models, emphasizing different change principles. However, the extent to which compatibility exists between different treatment components remains an underexplored scientific question. The present study aims to fill this gap.
Combining cognitive behavioral therapies
Cognitive behavioral therapies (CBTs) are among the most well-researched psychological treatments for anxiety and depressive disorders (Cuijpers, 2017; Cuijpers et al., 2014). While CBT is often viewed as one of the major schools of psychotherapy, specific CBTs differ in their rationale and understanding of the key maintaining processes in psychopathology (Hayes, 2004). A core tenet of traditional CBT, also known as second-wave CBT, is that psychopathology is maintained by maladaptive or irrational thoughts (Beck, 1976). Thus, a commonly used therapeutic component derived from second-wave CBT is cognitive restructuring, where the patient is taught to think more realistically about emotion-evoking situations (Beck et al., 1979; Clark & Beck, 2010). Thus, cognitive restructuring can be said to target the content of thoughts.
In contrast, newer contemporary or so-called third-wave CBTs such as metacognitive therapy (MCT), acceptance and commitment therapy (ACT), and mindfulness-based cognitive therapy (MBCT) target thought processes (Hayes, 2004). A commonly used therapeutic component across third-wave CBTs involves teaching the patient to meet their experiences with mindfulness and acceptance rather than attempting to change their form (termed detached mindfulness in MCT, defusion in ACT, and decentering in MCT; Hayes et al., 2012; Segal et al., 2002; Wells, 2009). Thus, it can be argued that second- and third-wave CBTs reflect very different ways of approaching one's inner life.
Despite the differences between second- and third-wave CBTs, treatment components from each wave are often combined. One example of this is the widely employed Unified Protocol (UP) which is a transdiagnostic modular cognitive-behavioral treatment for emotional disorders (e.g., anxiety and depression) (Barlow et al., 2018). In UP, patients are asked to engage in cognitive restructuring (within the treatment module of cognitive flexibility) in one module and to practice detached mindfulness (within the treatment module of mindful emotion awareness) in another (Barlow et al., 2018). Several studies have documented that UP is an effective treatment for anxiety and depression (Longley & Gleiser, 2023). However, since the treatment modules in UP are rooted in different therapeutic traditions with different rationales, an intriguing question remains whether the treatment modules are in fact compatible. If not, then it is possible that UP is effective not because but rather despite the combination of the treatment modules (O'Toole et al., 2024).
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 (Participant)
盲法说明
It will not be known to participants that we are testing combinatory and sequencing effects and that participants are randomly allocated to receive the treatment modules in a specific order.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •A diagnosis of an anxiety disorder (generalized anxiety disorder, social anxiety disorder, or panic disorder with or without agoraphobia) and/or mild to moderate major depressive disorder (MDD) according to DSM-5 (American Psychiatric Association, 2022).
- •Danish language proficiency.
- •Ability and willingness to give informed consent.
- •No or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 8 weeks).
- •Access to either a smartphone, tablet, or computer with video camera.
排除标准
- •Severe depression deemed to require more intense psychotherapy or medication.
- •Persistent depressive disorder (i.e., depressive symptoms have persisted for 2 years or more).
- •Non-stabilized medication (see above).
- •Currently receiving other psychotherapy or counseling.
- •Not capable of participating online.
- •Lack of Danish proficiency.
- •A history of bipolar disorder.
- •Current or past psychosis.
- •Substance abuse or dependence judged to require treatment.
- •Suicide risk requiring immediate hospitalization.
结局指标
主要结局
Depressive symptoms (PHQ-9)
时间窗: Development from pre-treatment to post-treatment (6 weeks)
Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001; Spitzer et al., 1999; Spitzer et al., 2000).
Symptoms of panic disorder (PDSS-SR)
时间窗: Development from pre-treatment to post-treatment (6 weeks)
The Panic Disorder Severity Scale - Self-Report Version (PDSS-SR; Houck et al., 2002).
Anxiety symptoms (BAI)
时间窗: Development from pre-treatment to post-treatment (6 weeks)
Beck's Anxiety Inventory (BAI; Beck et al., 1988; Beck \& Steer, 1991).
Symptoms of generalized anxiety disorder (GAD-7)
时间窗: Development from pre-treatment to post-treatment (6 weeks)
The General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006).
Symptoms of social anxiety disorder (SIAS)
时间窗: Development from pre-treatment to post-treatment (6 weeks)
The Social Interaction Anxiety Scale (SIAS; Mattick \& Clarke, 1998).
次要结局
- Subjective cognitive function (PDQ-D)(Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up)
- Experience of therapy(Session by session development during the 6 weeks of active treatment and through 3-month follow-up)
- Working alliance (WAI-SR)(Session 3 and 5 only)
- Worry (PSWQ)(Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up)
- Depressive symptoms (PHQ-9)(Development from pre-treatment through 3-month follow-up)
- Symptoms of panic disorder (PDSS-SR)(Development from pre-treatment through 3-month follow-up)
- Rumination (RRS brooding subscale)(Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up)
- Worry (AWS)(Session by session development during the 6 weeks of active treatment)
- Decentering (EQ decentering subscale)(Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up)
- Reappraisal (ERQ)(Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up)
- Mindfulness (FFMQ-15)(Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up)
- Anxiety symptoms (BAI)(Development from pre-treatment through 3-month follow-up)
- Symptoms of generalized anxiety disorder (GAD-7)(Development from pre-treatment through 3-month follow-up)
- Quality of life (WHO-5)(Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up)
- Symptoms of social anxiety disorder (SIAS)(Development from pre-treatment through 3-month follow-up)
- Information overload (IO)(Session by session development during the 6 weeks of active treatment)
