<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767101</url>
  </required_header>
  <id_info>
    <org_study_id>128/2018</org_study_id>
    <nct_id>NCT03767101</nct_id>
  </id_info>
  <brief_title>Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy</brief_title>
  <acronym>PACIfIC</acronym>
  <official_title>Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy: the PACIfIC-Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulrike Willutzki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Witten/Herdecke</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Research findings suggested that people with mental disorders show a&#xD;
      dysfunctional upregulation of negative affect (NA) but at the same time a dysfunctional&#xD;
      downregulation of positive affect (PA) as distinct processes. Nevertheless, established&#xD;
      treatment approaches focus on the modification of problems and negative affect only.&#xD;
      Experimental paradigms with healthy and subclinical populations showed that PA inductions&#xD;
      lead to higher flexibility in information processing, cognitive appraisal and action&#xD;
      tendencies. Higher amounts of PA were associated with more personal resources, higher&#xD;
      psychological resilience and subjective well-being. Preliminary evidence indicated that a&#xD;
      focus on positive and functional aspects in the life of patients lead to better treatment&#xD;
      sessions and outcome. However, the role of PA for the process in cognitive behavioral therapy&#xD;
      remains unclear.&#xD;
&#xD;
      Method/Design: In regard to this we developed the PACIfIC-study, serving the following&#xD;
      objectives:&#xD;
&#xD;
      (1) to explore the trajectories of PA and NA and their association with relevant process&#xD;
      variables in an early phase of CBT treatment. (2) To develop and test the feasibility of a&#xD;
      brief and easily implementable intervention to promote PA in psychotherapy sessions. (3) To&#xD;
      analyze the impact of this intervention on the therapeutic process between and within CBT&#xD;
      sessions and intermediate outcomes.&#xD;
&#xD;
      The study includes a randomized contolled, longitudinal design in an outpatient research and&#xD;
      treatment center. Both a process and an intervention analysis will be conducted. In the&#xD;
      process analysis, we will examine the course of PA and NA in the first twelve sessions of CBT&#xD;
      treatments. In the intervention analysis, we will examine the effects of a six-minute&#xD;
      positive mental imagery intervention during an early phase of psychotherapy. The aim of this&#xD;
      micro-intervention is to foster patients' in-session PA, which may lead to increased levels&#xD;
      of subjective resources, resilience, and self-esteem (theory-driven outcome) as well as&#xD;
      improvements in psychopathology and working alliance (secondary outcome).&#xD;
&#xD;
      Discussion: The study results may have important theoretical and practical implications on&#xD;
      the use of PA in psychotherapeutic treatment. Furthermore an economic implementation of&#xD;
      strengths-oriented interventions in psychotherapy practice may be initiated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 2, 2018</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive and Negative Affect Schedule (PANAS) -session questionnaire-</measure>
    <time_frame>Baseline; measured once per week for twelve weeks of treatment, directly after each session</time_frame>
    <description>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 &quot;in the current moment&quot;. 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Witten Resource Questionnaire (WIRF) -change measurement-</measure>
    <time_frame>Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Connor-Davidson Resilience Scale (CD-Risc) -change measurement-</measure>
    <time_frame>Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rosenberg Self-esteem Scale (RSES) -change measurement-</measure>
    <time_frame>Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief Symptom Inventory (BSI) -change measurement-</measure>
    <time_frame>Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)</time_frame>
    <description>Outcome of the intervention analysis. Internationally used self-report of symptom severity of patients [53 items].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Alliance Inventory - Short Revised (WAI-SR) -change measurement-</measure>
    <time_frame>Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)</time_frame>
    <description>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].</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Resource-oriented Microprocess Analysis (ROMA) -Coding system of videotapes of treatment sessions with an observer rating-</measure>
    <time_frame>In part video tapes of treatment sessions were analyzed; on average after two weeks, after five weeks and after eight weeks of treatment start</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Mental Disorders</condition>
  <arm_group>
    <arm_group_label>TAU + Positive mental imagery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU + Neutral mental imagery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy</intervention_name>
    <description>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.</description>
    <arm_group_label>TAU + Neutral mental imagery</arm_group_label>
    <arm_group_label>TAU + Positive mental imagery</arm_group_label>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least one mental disorder according to DSM-5 criteria&#xD;
&#xD;
          -  treatment at the center of Mental Health and Psychotherapy, Witten/Herdecke&#xD;
             University; outpatients clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current diagnosis of a severe episode of major depressive disorder&#xD;
&#xD;
          -  suffering from a psychotic disorder&#xD;
&#xD;
          -  suffering from substance use disorder&#xD;
&#xD;
          -  current episode of (hypo)mania&#xD;
&#xD;
          -  current suicidal risk&#xD;
&#xD;
          -  extensive experiences with guided mental imagery intervention&#xD;
&#xD;
          -  insufficient German language skills&#xD;
&#xD;
          -  currently receiving another psychological treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrike Willutzki, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Witten/Herdecke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philipp Victor, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Witten/Herdecke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Witten/Herdecke University</name>
      <address>
        <city>Witten</city>
        <state>North Rhine-Westphalia</state>
        <zip>58455</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 27, 2021</last_update_submitted>
  <last_update_submitted_qc>December 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Witten/Herdecke</investigator_affiliation>
    <investigator_full_name>Ulrike Willutzki</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Positive affect</keyword>
  <keyword>Mental imagery</keyword>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Psychotherapy process</keyword>
  <keyword>Micro-intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767101
org study id: 128/2018
nct id: NCT03767101
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Positive and Negative Affect Schedule (PANAS) -session questionnaire-
time frame: Baseline; measured once per week for twelve weeks of treatment, directly after each session
description: 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.
measure: Witten Resource Questionnaire (WIRF) -change measurement-
time frame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
description: 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).
measure: Connor-Davidson Resilience Scale (CD-Risc) -change measurement-
time frame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
description: 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).
measure: Rosenberg Self-esteem Scale (RSES) -change measurement-
time frame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
description: 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).
measure: Brief Symptom Inventory (BSI) -change measurement-
time frame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
description: Outcome of the intervention analysis. Internationally used self-report of symptom severity of patients [53 items].
measure: Working Alliance Inventory - Short Revised (WAI-SR) -change measurement-
time frame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
description: 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].
measure: Resource-oriented Microprocess Analysis (ROMA) -Coding system of videotapes of treatment sessions with an observer rating-
time frame: In part video tapes of treatment sessions were analyzed; on average after two weeks, after five weeks and after eight weeks of treatment start
description: 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.
arm group label: TAU + Positive mental imagery
arm group type: Experimental
description: 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.
arm group label: TAU + Neutral mental imagery
arm group type: Active Comparator
description: 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.
arm group label: Treatment as usual
arm group type: Other
description: 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.
intervention type: Behavioral
intervention name: Cognitive behavioral therapy
description: 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.
arm group label: TAU + Neutral mental imagery
arm group label: TAU + Positive mental imagery
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulrike Willutzki, Prof. Dr.
role: Study Chair
affiliation: Witten/Herdecke University
last name: Philipp Victor, Dr.
role: Principal Investigator
affiliation: Witten/Herdecke University
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University of Witten/Herdecke
investigator full name: Ulrike Willutzki
investigator title: Clinical Professor
mesh term: Mental Disorders