Clinical trial NCT03767101: Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy
Official title: Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy: the PACIfIC-Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorders
Keywords: Positive affect
Mental imagery
Cognitive Behavioral Therapy
Psychotherapy process
Micro-intervention
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Positive and Negative Affect Schedule (PANAS) -session questionnaire-
timeFrame: Baseline; measured once per week for twelve weeks of treatment, directly after each session
measure: Witten Resource Questionnaire (WIRF) -change measurement-
timeFrame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
measure: Connor-Davidson Resilience Scale (CD-Risc) -change measurement-
timeFrame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
measure: Rosenberg Self-esteem Scale (RSES) -change measurement-
timeFrame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Secondary outcomes:
measure: Brief Symptom Inventory (BSI) -change measurement-
timeFrame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
measure: Working Alliance Inventory - Short Revised (WAI-SR) -change measurement-
timeFrame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Other outcomes:
measure: Resource-oriented Microprocess Analysis (ROMA) -Coding system of videotapes of treatment sessions with an observer rating-
timeFrame: In part video tapes of treatment sessions were analyzed; on average after two weeks, after five weeks and after eight weeks of treatment start
Locations:
city: Witten
country: Germany
facility: Witten/Herdecke University
state: North Rhine-Westphalia
Study officials:
affiliation: Witten/Herdecke University
name: Ulrike Willutzki, Prof. Dr.
role: STUDY_CHAIR
affiliation: Witten/Herdecke University
name: Philipp Victor, Dr.
role: PRINCIPAL_INVESTIGATOR
References: