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Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy (PACIfIC)

2021年12月27日 更新者:Ulrike Willutzki

Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy: the PACIfIC-Study

Background: Research findings suggested that people with mental disorders show a dysfunctional upregulation of negative affect (NA) but at the same time a dysfunctional downregulation of positive affect (PA) as distinct processes. Nevertheless, established treatment approaches focus on the modification of problems and negative affect only. Experimental paradigms with healthy and subclinical populations showed that PA inductions lead to higher flexibility in information processing, cognitive appraisal and action tendencies. Higher amounts of PA were associated with more personal resources, higher psychological resilience and subjective well-being. Preliminary evidence indicated that a focus on positive and functional aspects in the life of patients lead to better treatment sessions and outcome. However, the role of PA for the process in cognitive behavioral therapy remains unclear.

Method/Design: In regard to this we developed the PACIfIC-study, serving the following objectives:

(1) to explore the trajectories of PA and NA and their association with relevant process variables in an early phase of CBT treatment. (2) To develop and test the feasibility of a brief and easily implementable intervention to promote PA in psychotherapy sessions. (3) To analyze the impact of this intervention on the therapeutic process between and within CBT sessions and intermediate outcomes.

The study includes a randomized contolled, longitudinal design in an outpatient research and treatment center. Both a process and an intervention analysis will be conducted. In the process analysis, we will examine the course of PA and NA in the first twelve sessions of CBT treatments. In the intervention analysis, we will examine the effects of a six-minute positive mental imagery intervention during an early phase of psychotherapy. The aim of this micro-intervention is to foster patients' in-session PA, which may lead to increased levels of subjective resources, resilience, and self-esteem (theory-driven outcome) as well as improvements in psychopathology and working alliance (secondary outcome).

Discussion: The study results may have important theoretical and practical implications on the use of PA in psychotherapeutic treatment. Furthermore an economic implementation of strengths-oriented interventions in psychotherapy practice may be initiated.

研究概览

地位

邀请报名

条件

研究类型

介入性

注册 (预期的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Rhine-Westphalia
      • Witten、North Rhine-Westphalia、德国、58455
        • Witten/Herdecke University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • at least one mental disorder according to DSM-5 criteria
  • treatment at the center of Mental Health and Psychotherapy, Witten/Herdecke University; outpatients clinic

Exclusion Criteria:

  • current diagnosis of a severe episode of major depressive disorder
  • suffering from a psychotic disorder
  • suffering from substance use disorder
  • current episode of (hypo)mania
  • current suicidal risk
  • extensive experiences with guided mental imagery intervention
  • insufficient German language skills
  • currently receiving another psychological treatment

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:TAU + Positive mental imagery
In all conditions the first eight sessions of treatment are focused. All sessions start with a brief, audio-tape presented positive mental imagery intervention (duration about six minutes). In this intervention patients are guided to imagine a happy, positive situation within the last seven days. Patients get the instruction to imagine from a field perspective, exploring various sensory modalities and feelings in that specific moment. Patients perform this task in the rooms of the treatment center together with their therapists. The text of the mental imagery intervention is standardized and spoken by Prof. Dr. Ulrike Willutzki. Directly before and after the imagination patients are asked on their mood with a single-item. After the short intervention patients are instructed to communicated the content of their imagination with their therapists for about one minute. After completion the regular cognitive behavioral therapy session begins.
In all three treatment arms, licensed therapists/trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. All treatments are based on individualized treatment plans for each patient. Therapists are supervized by an CBT expert therapist in the outpatient treatment center. On average every forth session is supervized. The total duration of treatment is variable, oriented on patients symptoms and treatment goals.
有源比较器:TAU + Neutral mental imagery
In all conditions the first eight sessions of treatment are focused. All sessions start with a brief, audio-tape presented neutral mental imagery intervention (duration about six minutes). In this intervention patients are guided to imagine a all-day, non-emotional provoking situation within the last seven days. Patients get the instruction to imagine from a field perspective, exploring various sensory modalities in that specific moment. Patients perform this task in the rooms of the treatment center together with their therapists. The text of the mental imagery intervention is standardized and spoken by Prof. Dr. Ulrike Willutzki. Directly before and after the imagination patients are asked on their mood with a single-item. After the short intervention patients are instructed to communicated the content of their imagination with their therapists for about one minute. After completion the regular cognitive behavioral therapy session begins.
In all three treatment arms, licensed therapists/trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. All treatments are based on individualized treatment plans for each patient. Therapists are supervized by an CBT expert therapist in the outpatient treatment center. On average every forth session is supervized. The total duration of treatment is variable, oriented on patients symptoms and treatment goals.
其他:Treatment as usual
In all conditions the first eight sessions of treatment are focused. No additional intervention is conducted at the start of therapy sessions. Standard cognitive behavioral therapy is conducted during the whole treatment sessions.
In all three treatment arms, licensed therapists/trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. All treatments are based on individualized treatment plans for each patient. Therapists are supervized by an CBT expert therapist in the outpatient treatment center. On average every forth session is supervized. The total duration of treatment is variable, oriented on patients symptoms and treatment goals.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Positive and Negative Affect Schedule (PANAS) -session questionnaire-
大体时间:Baseline; measured once per week for twelve weeks of treatment, directly after each session
Outcome of the process analysis. International used self-report of positive and negative affect [20 items]. Participants will be asked to rate the items according to how they feel "in the current moment". Two subscales of global positive affect (ten items, range: 1-5) and global negative affect (10 items, range: 1-5) will be used separately. Subscale scores will be computed with averaged item scores.
Baseline; measured once per week for twelve weeks of treatment, directly after each session
Witten Resource Questionnaire (WIRF) -change measurement-
大体时间:Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Outcome of the intervention analysis. Self-report of psychosocial resources [subscale with 12 items]. A total score will be computed with averaged item scores (range: 0-5).
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Connor-Davidson Resilience Scale (CD-Risc) -change measurement-
大体时间:Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Outcome of the intervention analysis. Internationally used self-report of psychological resilience [short version: 10 items]. A total score will be computed with averaged item scores (range: 1-7).
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Rosenberg Self-esteem Scale (RSES) -change measurement-
大体时间:Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Outcome of the intervention analysis. Internationally used self-report of general self-esteem [10 items]. A total score will be computed with summed item scores (range: 0-30).
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)

次要结果测量

结果测量
措施说明
大体时间
Brief Symptom Inventory (BSI) -change measurement-
大体时间:Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Outcome of the intervention analysis. Internationally used self-report of symptom severity of patients [53 items].
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Working Alliance Inventory - Short Revised (WAI-SR) -change measurement-
大体时间:Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Outcome of the intervention analysis. Internationally used self-report of therapeutic alliance measuring bond, goals and tasks in psychotherapy based on feedback of patients concerning the current therapy session [12 items].
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)

其他结果措施

结果测量
措施说明
大体时间
Resource-oriented Microprocess Analysis (ROMA) -Coding system of videotapes of treatment sessions with an observer rating-
大体时间:In part video tapes of treatment sessions were analyzed; on average after two weeks, after five weeks and after eight weeks of treatment start
Video-based coding system of different aspects of resource activation (resource units: personal resources, motivational resources, reframing of problems) and positive affectivity in treatment sessions on a minute-level in both patients and therapists. Videotapes are analyzed from an observer perspective.
In part video tapes of treatment sessions were analyzed; on average after two weeks, after five weeks and after eight weeks of treatment start

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Ulrike Willutzki, Prof. Dr.、Witten/Herdecke University
  • 首席研究员:Philipp Victor, Dr.、Witten/Herdecke University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年11月2日

初级完成 (预期的)

2022年12月1日

研究完成 (预期的)

2023年3月1日

研究注册日期

首次提交

2018年11月26日

首先提交符合 QC 标准的

2018年12月5日

首次发布 (实际的)

2018年12月6日

研究记录更新

最后更新发布 (实际的)

2022年1月13日

上次提交的符合 QC 标准的更新

2021年12月27日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 128/2018

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

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