| Methods |
Study design: RCT
Study grouping: parallel group
Unit of randomisation: individuals
Power (power & sample size calculation, level of power achieved): not specified
Imputation of missing data: no imputation of missing data; probably per‐protocol analysis (see flow chart; without 33 exclusions in both groups and without 7 participants who discontinued intervention; n = 50 analysed) |
| Participants |
Country: USA
Setting: recruitment from college; training and CO2 breathing challenge in laboratory
Age: not specified
Sample size (randomised): 90
Sex: not specified
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified
Population description: college students
Inclusion criteria: college students scoring 27,5 or higher on the ASI
Exclusion criteria: 1) serious, unstable illnesses, including type I and type II diabetes mellitus, hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or haematologic disease; 2) 1 or more past seizures without a clear and resolved aetiology; 3) a concussion or other head trauma within the past month; 4) current or past episodes of psychosis; 5) currently taking antidepressants or a non‐psychotropic medication with psychotropic effects (e.g. beta‐adrenergic blockers), unless the dosage has been stable for a minimum of 1 month prior to the study; 6) self‐reported confirmation or possibility of pregnancy; 7) no benzodiazepine medication for at least 48 hours prior to final session of the study (CO2 breathing challenge)
Attrition (withdrawals and exclusions): 7 withdrawals from interventions (IG: 2, CG: 5); 5 lost to follow‐up (IG: 2, CG: 3); 33 exclusions (IG: 14, CG:19)
Reasons for missing data: 33 exclusions (did not meet ASI cut‐off at study session 1); PDSS not usable to assess outcomes (administered at baseline, post‐training and follow‐up, but due to skip pattern in the measure, only 16 completed full measure at all time points); reasons for losses to follow‐up or withdrawals from intervention not specified |
| Interventions |
Intervention: Cognitive Bias Modification‐Interpretation (CBM‐I) (Ambiguous Scenario Training) (n = 45)
delivery: computer paradigm (Cognitive Bias Modification‐Interpretation); presentation of scenarios designed to be ambiguous, but potentially threatening to someone with high anxiety sensitivity providers: not specified duration of treatment period and timing: 4 x 30‐minute sessions (50 novel scenario trials in each session) -
description:
Modified CBM‐I in this study trains interpretations associated with resilience (in contrast to typical CBM‐I paradigms that train contingency between ambiguous threat and positive, anxiety‐incongruent outcomes) Scenarios target factors thought to underlie anxiety‐sensitive individuals’ difficulty recovering from a panic stressor (e.g. fixed beliefs that being anxious is catastrophic, and that they will not recover) At the end of a scenario, participants are presented with a final sentence containing a word fragment to be completed by selecting the missing letter (there is only one solution to one fragment) This word fragment resolves the ambiguity of each scenario in a resilience‐congruent (i.e. healthy) direction These resilience‐enhancing resolutions include greater flexibility in responding, greater self‐efficacy, finding meaning or a silver lining in response to a stressor, and the expression of positive emotionality despite the presence of a stressor; e.g. sample scenario: ‘‘You are at an amusement park and decide to ride a roller coaster with your friends. After you get off the ride, you are a bit dizzy and your legs feel weak. Although this makes you anxious, you can still l_ugh with the rest of your friends about how fun the ride was.’’ The final sentence and word fragment (‘‘laugh’’) in this scenario create a resolution that promotes positive emotional expression Finally, each scenario is followed by a comprehension question that requires a ‘‘yes’’ or ‘‘no’’ answer and is designed to reinforce the resolution of the ambiguity. e.g. question for the scenario above: ‘‘Are you able to laugh with the rest of your friends despite feeling anxious?’’; Participants are not allowed to advance through training until they provide the correct missing letter for the word fragment, and then the correct answer to the comprehension question. If participants complete the trials for a given session prior to the end of the 30 minutes, they then undergo a modified iteration of the same scenarios until the time has expired (e.g. reading the scenarios aloud), following Steinman 2014. The first iteration requires participants to read the trials aloud, and the second iteration asks participants to complete three letters from the word fragment in the final sentence
compliance: 43 of 45 allocated to IG completed intervention (i.e. 2 discontinued study prior to follow‐up) integrity of delivery: not specified economic information: not specified theoretical basis: CBM; Ambiguous Scenario Training adapted from Mathews 2000
Control: attention control (sham version); neutral version of CBM (n = 45)
delivery: computer paradigm (CBM‐I); presentation of scenarios that are neutral in valence providers: not specified duration of treatment period and timing: 4 x 30‐minute sessions -
description:
None of the trials were related to the development of resilience, and approximately 75% of the trials were unrelated to anxiety sensitivity content (the decision to allow 25% of the content to relate to anxiety sensitivity was made to enhance credibility of the control condition) CG task designed to match the Ambiguous Scenario Training paradigm for task demands, such as attention, time, format, and other nonspecific factors e.g. control scenario: ‘‘You are watering your household plants. As you make your way around the house, you notice that one of your plants is wilting. You decide to move the plant into more direct sunli_ht.’’ The comprehension question for this scenario was: “Are you watering your plants?”
compliance: 40 of 45 allocated to CG completed intervention (i.e. 5 discontinued study prior to follow‐up) integrity of delivery: not specified economic information: not specified theoretical basis: variation of Ambiguous Scenario Training with scenario content neutral in valance (Steinman 2014)
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| Outcomes |
Outcomes collected and reported:
anxiety sensitivity ‐ ASI panic disorder severity ‐ PDSS ‐ not reported at post‐test and follow‐up resilience‐relevant interpretation bias – resilience‐congruent recognition ratings ‐ RRT resilience‐relevant interpretation bias – resilience‐incongruent recognition ratings ‐ RRT physical interpretations/anxiety‐relevant interpretations ‐ Brief Body Sensations Interpretation Questionnaire Physical subscale state anxiety ‐ SUDS panic attack symptoms ‐ Diagnostic Symptom Questionnaire (sum score, physical symptoms, cognitive symptoms)
Time points measured and reported: 1) pre‐intervention; 2) post‐intervention; 3) 2‐month follow‐up (2 months after final laboratory session)
Adverse events: not specified |
| Notes |
Contact with authors: We contacted the authors for the number of participants analysed in each group at post‐test and follow‐up as well as means and SDs for SUDS at the beginning and at the end of CO2 breathing challenge in both conditions. In a second inquiry, we also asked if healthcare students were included in the sample. We received the response from the authors that "all of the participants were college undergraduates enrolled in a participant pool from introductory psychology courses, but there were no additional information about whether of the participants may have been health professionals, though this is unlikely" (Beadel 2019 [pers comm]).
Study start/end date: not specified
Funding source: funded by a Templeton Science of Prospection Award to Bethany Teachman
Declaration of interest: Jessica R. Beadel, Andrew Mathews, Bethany A. Teachman declares that they have no conflict of interest
Ethical approval needed/obtained for study: not specified
Comments by study authors: not relevant
Miscellaneous outcomes by the review authors: according to authors, college undergraduates enrolled in participant pool from introductory psychology courses; unclear if any health professionals (though unlikely)
Correspondence: Jessica R. Beadel, University of Virginia, P.O. Box 400400, Charlottesville, VA 22904, USA; jrb2mx@virginia.edu |
