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

Primary Purpose

Mental Disorders

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Sponsored by
Ulrike Willutzki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Positive affect, Mental imagery, Cognitive Behavioral Therapy, Psychotherapy process, Micro-intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Witten/Herdecke University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

TAU + Positive mental imagery

TAU + Neutral mental imagery

Treatment as usual

Arm 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.

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 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.

Outcomes

Primary Outcome Measures

Positive and Negative Affect Schedule (PANAS) -session questionnaire-
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.
Witten Resource Questionnaire (WIRF) -change measurement-
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).
Connor-Davidson Resilience Scale (CD-Risc) -change measurement-
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).
Rosenberg Self-esteem Scale (RSES) -change measurement-
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).

Secondary Outcome Measures

Brief Symptom Inventory (BSI) -change measurement-
Outcome of the intervention analysis. Internationally used self-report of symptom severity of patients [53 items].
Working Alliance Inventory - Short Revised (WAI-SR) -change measurement-
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].

Full Information

First Posted
November 26, 2018
Last Updated
December 27, 2021
Sponsor
Ulrike Willutzki
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1. Study Identification

Unique Protocol Identification Number
NCT03767101
Brief Title
Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy
Acronym
PACIfIC
Official Title
Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy: the PACIfIC-Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ulrike Willutzki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Positive affect, Mental imagery, Cognitive Behavioral Therapy, Psychotherapy process, Micro-intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU + Positive mental imagery
Arm Type
Experimental
Arm 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 Title
TAU + Neutral mental imagery
Arm Type
Active Comparator
Arm 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 Title
Treatment as usual
Arm Type
Other
Arm 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(s)
Cognitive behavioral therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Positive and Negative Affect Schedule (PANAS) -session questionnaire-
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.
Time Frame
Baseline; measured once per week for twelve weeks of treatment, directly after each session
Title
Witten Resource Questionnaire (WIRF) -change measurement-
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).
Time Frame
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Title
Connor-Davidson Resilience Scale (CD-Risc) -change measurement-
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).
Time Frame
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Title
Rosenberg Self-esteem Scale (RSES) -change measurement-
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).
Time Frame
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Secondary Outcome Measure Information:
Title
Brief Symptom Inventory (BSI) -change measurement-
Description
Outcome of the intervention analysis. Internationally used self-report of symptom severity of patients [53 items].
Time Frame
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Title
Working Alliance Inventory - Short Revised (WAI-SR) -change measurement-
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].
Time Frame
Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Other Pre-specified Outcome Measures:
Title
Resource-oriented Microprocess Analysis (ROMA) -Coding system of videotapes of treatment sessions with an observer rating-
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Willutzki, Prof. Dr.
Organizational Affiliation
Witten/Herdecke University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Philipp Victor, Dr.
Organizational Affiliation
Witten/Herdecke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Witten/Herdecke University
City
Witten
State/Province
North Rhine-Westphalia
ZIP/Postal Code
58455
Country
Germany

12. IPD Sharing Statement

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

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