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Completed

NCT Number: NCT05261594

Effects of Caffeine on Anxiety, Emotional Processing, Approach-avoidance Behavior, and Interoception in Panic Disorder

The current study is a placebo-controlled, double-blind, randomized controlled study using a cross-over design, including participants with Panic disorder and healthy controls.

The study's primary aim is to investigate the effects of caffeine (vs placebo) on self-reported anxiety and its impact on emotional reactivity and goal-directed behavior in individuals with Panic disorder (vs healthy controls). Emotional reactivity will be measured with self-reported emotions and skin conductance responses. Caffeine-induced effects on goal-directed behavior will be assessed using an approach-avoidance conflict paradigm and an effort-allocation task. The occurrence of panic attacks and panic-related symptoms will also be measured. Furthermore, the link between a genotype of ADORA2A (rs5751876 T/T) previously associated with caffeine-induced anxiety, and the anxiogenic effects of caffeine will also be explored. In addition, caffeine-induced changes in attention to interoceptive stimuli (bodily sensation such as pulse and respiration) and anxiety elicited by attention to interoceptive stimuli will be explored. A secondary aim is to examine the potential caffeine-induced effects and the impact of genetic variation in healthy participants (caffeine vs placebo).

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Key information

Conditions

Panic Disorder Anxiety Disorders Healthy Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala university, Department of Medical Sciences, Psychiatry

Uppsala, 75185, Sweden

About this study

Hypotheses

Self-reported anxiety during resting state

  • Participants with Panic disorder will report higher resting-state levels of anxiety and negative emotions during the caffeine condition vs the placebo condition.
  • Participants with Panic disorder will report higher resting-state levels of caffeine-induced (caffeine > placebo) anxiety and negative emotions compared to healthy subjects.

Panic attacks

  • The occurrence of panic attacks and panic-related symptoms will be higher among participants with Panic disorder than in healthy controls in both conditions (caffeine and placebo).

Genetic variation

  • Carriers of adenosine A2A receptor (i.e., ADORA2A) polymorphism (rs5751876 T/T) will report higher levels of caffeine-induced (caffeine >placebo) anxiety and negative emotions, in both individuals with Panic disorder and healthy participants.

Attention to interoceptive stimuli and associated anxiety

  • Participants with Panic disorder will report higher levels of attention towards interoceptive stimuli in the caffeine condition (vs placebo).
  • Participants with Panic disorder will report higher levels of self-reported anxiety associated with experiencing interoceptive stimuli during the caffeine condition (vs placebo).
  • Participants with Panic disorder will report higher levels of self-reported attention to interoceptive stimuli and anxiety associated with experiencing interoceptive stimuli compared to healthy participants, both in general (placebo condition) and after caffeine intake (caffeine vs placebo).

Exploratory research questions

Analyses of emotional reactivity, the approach-avoidance conflict task, and the effort-allocation task will be exploratory without directed hypotheses, due to lack of previous research on the effects of caffeine in patients with Panic disorder on these tasks. We will also conduct exploratory analyses to explore if 150 mg of caffeine (vs placebo) affect self-reported levels of positive emotions in patients with Panic disorder and healthy controls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Panic disorder group: Primary diagnosis of panic disorder.

Healthy control group: No current or history of psychiatric disorders.

All participants (Panic disorder and healthy): Weekly caffeine consumption ≤ 300 mg.

Exclusion criteria

History of severe psychiatric disorder (e.g. schizophrenia). Somatic or neurological conditions (e.g. hypertension and heart condition). Ongoing treatment with psychotropic medication or treatment with psychotropic medication which has been discontinued within 2 months. Other ongoing treatments that may confound the results. Current drug or alcohol abuse/dependency. Habitual nicotine use. Uncorrected visual or hearing impairment. Pregnancy.

Treatment and study plan

Caffeine

Dietary Supplement

Caffeine capsule 150 mg, oral intake

Placebo

Drug

Placebo capsule, oral intake

Primary outcomes

  1. Self-reported anxiety

    Time frame: Session 1 (day 1)

    Anxiety will be assessed before capsule (caffeine/placebo) intake, 30 minutes after intake during rest, and after each task with self-reported ratings on a scale from 0-100 (0=no anxiety - 100=extreme anxiety).

  2. Self-reported anxiety

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    Anxiety will be assessed before capsule (caffeine/placebo) intake, 30 minutes after intake during rest, and after each task with self-reported ratings on a scale from 0-100 (0=no anxiety - 100=extreme anxiety).

Secondary outcomes

  1. Self-reported emotions

    Time frame: Session 1 (day 1)

    Self-reported emotions (fear, bodily discomfort, negative feelings and positive feelings) will be assessed before capsule (caffeine/placebo) intake, 30 minutes after intake during rest, and after each task with self-reported ratings on a scale from 0-100 (0=none - 100=extreme).

  2. Self-reported emotions

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    Self-reported emotions (fear, bodily discomfort, negative feelings and positive feelings) will be assessed before capsule (caffeine/placebo) intake, 30 minutes after intake during rest, and after each task with self-reported ratings on a scale from 0-100 (0=none - 100=extreme).

  3. Skin conductance responses (SCR)

    Time frame: Session 1 (day 1)

    SCR:s will be used to assess emotional reactivity at the physiological level to emotional stimuli vs neutral stimuli (faces).

  4. Skin conductance responses (SCR)

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    SCR:s will be used to assess emotional reactivity at the physiological level to emotional stimuli vs neutral stimuli (faces).

  5. Approach-avoidance behavior

    Time frame: Session 1 (day 1)

    Approach-avoidance behavior will be assessed through an approach-avoidance incentive conflict task.

  6. Approach-avoidance behavior

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    Approach-avoidance behavior will be assessed through an approach-avoidance incentive conflict task.

  7. Effort-allocation

    Time frame: Session 1 (day 1)

    Effort-allocation for rewards will be assessed using an effort-allocation task.

  8. Effort-allocation

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    Effort-allocation for rewards will be assessed using an effort-allocation task.

  9. Occurrence of panic attack

    Time frame: Session 1 (day 1)

    The occurrence of a panic attacks will be assessed according to the Diagnostical Statistical Manual (DSM-5) criteria for panic attacks and will be coded dichotomous as "Present" or "Not present".

  10. Occurrence of panic attack

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    The occurrence of a panic attacks will be assessed according to the Diagnostical Statistical Manual (DSM-5) criteria for panic attacks and will be coded dichotomous as "Present" or "Not present".

  11. Panic symptoms

    Time frame: Session 1 (day 1)

    Panic symptoms will be assessed by counting the number of DSM-5- panic attack symptoms reported by the participant.

  12. Panic symptoms

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    Panic symptoms will be assessed by counting the number of DSM-5- panic attack symptoms reported by the participant.

  13. Attention to interoceptive stimuli

    Time frame: Session 1 (day 1)

    Attention to interoceptive stimuli will be assessed using self-reported ratings on a scale from 0-100 (0=no attention - 100= full attention). Interoceptive stimuli are defined as bodily sensation such as pulse and respiration.

  14. Attention to interoceptive stimuli

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    Attention to interoceptive stimuli will be assessed using self-reported ratings on a scale from 0-100 (0=no attention - 100= full attention). Interoceptive stimuli are defined as bodily sensation such as pulse and respiration.

  15. Anxiety associated with attention to interoceptive stimuli

    Time frame: Session 1 (day 1)

    Self-reported ratings of anxiety associated with attention to interoceptive stimuli (bodily sensation such as pulse and respiration) will be assessed using self reported ratings on a scale from (0= no anxiety - 100 = extreme anxiety)

  16. Anxiety associated with attention to interoceptive stimuli

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    Self-reported ratings of anxiety associated with attention to interoceptive stimuli (bodily sensation such as pulse and respiration) will be assessed using self reported ratings on a scale from (0= no anxiety - 100 = extreme anxiety)

Other outcomes

  1. Expectancy ratings

    Time frame: Session 1 (day 1)

    Participants will be asked to report if they believed that they received placebo or caffeine and how certain they are on a scale from 0-100%

  2. Expectancy ratings

    Time frame: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

    Participants will be asked to report if they believed that they received placebo or caffeine and how certain they are on a scale from 0-100%

  3. Panic Disorder Severity Scale (PDSS)

    Time frame: 1-7 days prior to session 1 (internet)

    PDSS is a self-reported questionnaire that assesses the severity of Panic disorder; range 0-28, higher scores indicating more severe symptoms

  4. Body Sensations Questionnaire (BSQ)

    Time frame: 1-7 days prior to session 1 (via internet)

    BSQ assesses body sensations present during aversive situations; range 17-85, higher scores indicating higher levels of body sensations

  5. Multidimensional Assessment of Interoceptive Awareness (MAIA-2)

    Time frame: 1-7 days prior to session 1 (via internet)

    MAIA-2 is an 8-scale state-trait questionnaire with 37 items to measure multiple dimensions of interoception by self-report. The score of each scale is the the average of the items on each scale. Higher mean scores indicate higher levels on of the measured dimensions (Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness,Self-Regulation, Body Listening, and Trust) on a scale from 0-5 (0=never- 5=always), respectively

  6. Anxiety Sensitivity Index (ASI)

    Time frame: 1-7 days prior to session 1 (via internet)

    ASI assesses anxiety sensitivity; range 0-64, higher scores indicating higher anxiety sensitivity

  7. Spielberger State-Trait Anxiety Inventory (STAI-T)

    Time frame: 1-7 days prior to session 1 (via internet)

    STAI-T is a self-rated questionnaire assessing trait anxiety; range 20-80, higher scores represent higher levels of trait anxiety

  8. Caffeine Expectancy Questionnaire (CaffEQ)

    Time frame: 1-7 days prior to session 1 (via internet)

    CaffEQ is a self-rated questionnaire that assesses expected effect of caffeine intake.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Effects of Caffeine on Anxiety, Emotional Processing, Approach-avoidance Behavior, and Interoception in Panic Disorder - a Double Blind Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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