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

Mental Disorders Clinical Trial

— PACIfIC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03767101
• Other study ID #: 128/2018
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: March 2023

Study information

• Verified date: December 2021
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders

Intervention

Behavioral:
• Cognitive behavioral therapy
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.

Locations

Country	Name	City	State
Germany	Witten/Herdecke University	Witten	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Ulrike Willutzki

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resource-oriented Microprocess Analysis (ROMA) -Coding system of videotapes of treatment sessions with an observer rating-	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
Primary	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
Primary	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)
Primary	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)
Primary	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	Brief Symptom Inventory (BSI) -change measurement-	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)
Secondary	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].	Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)