Mental DisordersPACIfICNCT03767101
Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy
A study testing Cognitive behavioral therapy in people with Mental Disorders, run by Ulrike Willutzki at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 2 Nov 2018to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least one mental disorder according to DSM-5 criteria
- treatment at the center of Mental Health and Psychotherapy, Witten/Herdecke University; outpatients clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Witten/Herdecke University
Witten, North Rhine-Westphalia, 58455
About this study
Official title: Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy: the PACIfIC-Study
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:
Read more
(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.
- Conditions
- Mental Disorders
- Being tested
- Cognitive behavioral therapy
- Keywords
- Positive affect, Mental imagery, Cognitive Behavioral Therapy, Psychotherapy process, Micro-intervention
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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-
Outcome of the intervention analysis. Internationally used self-report of symptom severity of patients [53 items].
Measured: 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-
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].
Measured: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start2 Nov 2018
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulrike Willutzki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulrike Willutzki, University of Witten/Herdecke
- Investigators
- Ulrike Willutzki, Prof. Dr., Study chair, Witten/Herdecke UniversityPhilipp Victor, Dr., Principal investigator, Witten/Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767101
- Sponsor's protocol ID
- 128/2018
- Acronym
- PACIfIC
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2018
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39089326
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy: the PACIfIC-Study
- ClinicalTrials.gov ID
- NCT03767101
- Acronym / sponsor ID
- PACIfIC / 128/2018
- Conditions
- Mental Disorders
- Keywords
- Positive affect, Mental imagery, Cognitive Behavioral Therapy, Psychotherapy process, Micro-intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ulrike WillutzkiUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAU + Positive mental imagery | Experimental | Behavioral: Cognitive behavioral therapyIn 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. |
| TAU + Neutral mental imagery | Active comparator | Behavioral: Cognitive behavioral therapyIn 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. |
| Treatment as usual | Other | Behavioral: Cognitive behavioral therapyIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least one mental disorder according to DSM-5 criteria
- treatment at the center of Mental Health and Psychotherapy, Witten/Herdecke University; outpatients clinic
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyIn 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. | Behavioural | TAU + Neutral mental imagery, TAU + Positive mental imagery, Treatment as usual |
Primary outcome
Positive and Negative Affect Schedule (PANAS) -session questionnaire-
Time frame: Baseline; measured once per week for twelve weeks of treatment, directly after each session
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-
Time frame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
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-
Time frame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
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-
Time frame: Baseline, mid-4 (after four weeks), mid-8 (after eight weeks), post-12 (after twelve weeks of treatment)
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).
2 secondary outcomes
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 39089326Schurmann-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Willutzki, Prof. Dr. study chair
Witten/Herdecke University
Philipp Victor, Dr. principal investigator
Witten/Herdecke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Mental Disorders, run by Ulrike Willutzki at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.