Clinical trial NCT06357364: Neural Changes Following Cognitive Behavior Therapy for Procrastination
Official title: Neural Changes Following Cognitive Behavior Therapy (CBT) for Procrastination: An fMRI and EEG Randomized Controlled Trial of Two CBT Protocols
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Procrastination
Lead sponsor: Nencki Institute of Experimental Biology of the Polish Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: SWPS University of Social Sciences and Humanities
name: Institute of Psychology, Polish Academy of Sciences
First posted: 2024-04-10
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of and the neural changes following two cognitive behavior therapy (CBT) protocols for procrastination with a wait-list control group. The interventions will be delivered online in group settings. Both protocols include identical psychoeducation and cognitive modules aiming at identification and modification of dysfunctional automatic thoughts related to procrastination but will differ in the behavioral modules. The behavioral module in the first protocol is focused on timely beginning and realistic planning. The second protocol implements working time restriction. The wait-list control group will receive one of the CBT protocols after a waiting period that will last as long as the CBT intervention and the assessments performed directly after treatment. It is assumed that the interventions will be superior to the wait-list control. Primary (procrastination) and secondary (depression and anxiety) measures will be collected prior to and after the interventions (or waiting period in the wait-list group) and after 6 months in the two active condition groups. Additionally, neuroimaging measurements will be conducted before and after the interventions (or waiting period in the wait-list group). Approximately half of the participants will undergo functional Magnetic Resonance Imaging (fMRI), and another half will undergo electroencephalography (EEG). Both methods are aimed at exploring neural correlates of the expected improvements in participants' self-regulation abilities.


Eligibility criteria: Inclusion Criteria:

* Bachelor's and Master's university students
* Self-reported primary difficulties related to chronic and severe procrastination
* Serious procrastination problem lasting for at least one year as confirmed during clinical interview
* Having a postponed/procrastinated project to complete in the course of therapy
* Willing to participate in the study
* Fluent in Polish language
* Computer access and stable Internet connection

Exclusion Criteria:

* Current participation in other psychotherapy
* Use of psychiatric medication during the last 12 weeks
* Severe anxiety or affective disorders or any other severe psychiatric disorders that require other types of specialized care and are primary to procrastination problem (e.g. major depressive episode, social phobia, PTSD, etc.)
* Active suicidality
* Psychosis, bipolar disorder
* Alcohol or substance dependence
* Severe personality disorders (with the exclusion of avoidant, dependent and obsessive-compulsive personality disorders)
* For Warsaw participants: contradictions for fMRI measurement (metal elements in the body, claustrophobia, neurological conditions, pregnancy etc), non right-handedness.
* For Poznań participants: neurological conditions (e.g. epilepsy)

Primary outcomes:
measure: Change in Polish version of the Pure Procrastination Scale (PPS)
timeFrame: baseline assessment (week 0); mid-treatment assessment (week 3); post-treatment assessment (week 6); follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Aitken Procrastination Inventory (API)
timeFrame: baseline assessment (week 0); mid-treatment assessment (week 3); post-treatment assessment (week 6); follow-up assessment (6 months after post-treatment assessment)
Secondary outcomes:
measure: Change in Polish version of the Patient Health Questionnaire (PHQ-9)
timeFrame: baseline assessment (week 0); mid-treatment assessment (week 3); post-treatment assessment (week 6); follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Generalized Anxiety Disorder Questionnaire-7 (GAD-7)
timeFrame: baseline assessment (week 0); mid-treatment assessment (week 3); post-treatment assessment (week 6); follow-up assessment (6 months after post-treatment assessment)
measure: Percentage of completion of a particular project that the participant decided to work on during the training (e.g. a thesis, an essay, a report).
timeFrame: baseline assessment (week 0); mid-treatment assessment (week 3); post-treatment assessment (week 6)
Other outcomes:
measure: Change in Polish version of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire - Short Form (SPSRQ-SF)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Multidimensional-Multiattributional Causality Scale (MMCS)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Performance Failure Appraisal Inventory (PFAI)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Difficulties in Emotion Regulation questionnaire (DERS)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Motivation Diagnostic Test (MDT)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Zimbardo Time Perspective Inventory
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Metacognitive Beliefs about Procrastination Questionnaire (MBPQ)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Impulsivity Scale (UPPS-P)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Self-control Scale (NAS-50)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of the Procrastination Diagnostic Criteria Questionnaires (PDCQ)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6), follow-up assessment (6 months after post-treatment assessment)
measure: Change in Polish version of Positive and Negative Affect Schedule (PANAS) in relation to a project that the participant decided to work on during the training (e.g. a thesis, an essay, a report)
timeFrame: baseline assessment (week 0), mid-treatment assessment (week 3), post-treatment assessment (week 6
measure: Polish version of the Group Session Rating Scale (GSRS)
timeFrame: During the intervention: at the end of every psychotherapy session (weeks 1-5)
measure: Several items concerning homework compliance (cf. Kazantzis et al., 2005).
timeFrame: after sessions 2-5 (weeks 3-6) and at follow-up (6 months after post-treatment assessment)
measure: Polish version of the Credibility Expectancy Questionnaire (CEQ)
timeFrame: After the first session (week 1)
measure: Polish version of the Negative Effects Questionnaire (NEQ)
timeFrame: Post-treatment (week 6)
measure: Polish version of the Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-treatment (week 6)
measure: fMRI measurements
timeFrame: baseline assessment (week 0), post-treatment assessment (week 6)
measure: Electroencephalography (EEG) measurements
timeFrame: baseline assessment (week 0), post-treatment assessment (week 6)
Locations:
city: Warsaw
country: Poland
facility: Nencki Institute of Experimental Biology, Polish Academy of Sciences
Study officials:
affiliation: Nencki Institute of Experimental Biology, Polish Academy of Sciences
name: Marek Wypych, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: SWPS University of Social Sciences and Humanities
name: Jarosław Michałowski, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Psychology, Polish Academy of Sciences
name: Joachim Kowalski, PhD
role: PRINCIPAL_INVESTIGATOR
References: