NCT03767101

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

4.1 years

First QC Date

November 26, 2018

Last Update Submit

December 27, 2021

Conditions

Keywords

Positive affectMental imageryCognitive Behavioral TherapyPsychotherapy processMicro-intervention

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline; measured once per week for twelve weeks of treatment, directly after each session

  • 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).

    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-

    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-

    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)

Secondary Outcomes (2)

  • Brief Symptom Inventory (BSI) -change measurement-

    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-

    Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)

Other Outcomes (1)

  • Resource-oriented Microprocess Analysis (ROMA) -Coding system of videotapes of treatment sessions with an observer rating-

    In part video tapes of treatment sessions were analyzed; on average after two weeks, after five weeks and after eight weeks of treatment start

Study Arms (3)

TAU + Positive mental imagery

EXPERIMENTAL

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.

Behavioral: Cognitive behavioral therapy

TAU + Neutral mental imagery

ACTIVE COMPARATOR

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.

Behavioral: Cognitive behavioral therapy

Treatment as usual

OTHER

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.

Behavioral: Cognitive behavioral therapy

Interventions

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.

TAU + Neutral mental imageryTAU + Positive mental imageryTreatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Witten/Herdecke University

Witten, North Rhine-Westphalia, 58455, Germany

Location

Related Publications (1)

  • Schurmann-Vengels J, Fluckiger C, Reyer E, Odyniec P, Willutzki U. The Impact of Mental Imagery Instructions on Patients' and Therapists' Positive Affect and Strength-Based Behaviours Within Psychotherapy Sessions: A Randomized Controlled Process Study. Clin Psychol Psychother. 2024 Jul-Aug;31(4):e3036. doi: 10.1002/cpp.3036.

MeSH Terms

Conditions

Mental Disorders

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ulrike Willutzki, Prof. Dr.

    Witten/Herdecke University

    STUDY CHAIR
  • Philipp Victor, Dr.

    Witten/Herdecke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 26, 2018

First Posted

December 6, 2018

Study Start

November 2, 2018

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations