Effect of Personalized Feedback Intervention (PFI) with Fear Appeal on Alcohol Consumption Pattern in Patients with Alcohol-induced Delirium: Protocol of an Open-label Randomized Controlled Trial

Abstract

Background:

Alcohol dependence is prevalent, with significant morbidity and mortality linked to alcohol-induced delirium. A new but less studied strategy integrating personalized feedback intervention (PFI) with fear appeal has shown promise in modifying behavior.

Novelty:

There is limited evidence to suggest that using patients’ own videotaped recordings in a delirious state can reduce relapse and enhance abstinence. Our study evaluates the combined effect of both PFI and fear appeal on reducing alcohol use and prolonging abstinence.

Objectives:

This study aims to evaluate the impact of PFI with fear appeal on alcohol consumption patterns in terms of duration of abstinence and amount of alcohol consumption in patients with delirium.

Methods:

This open-label randomized controlled trial will recruit 48 patients (purposive sampling) aged >18 years, any gender diagnosed with alcohol-induced delirium at AIIMS Bibinagar. Participants will be assessed for withdrawal severity and delirium using standardized tools. They will be randomly allocated (opaque sealed envelopes) to two groups: (a) PFI with fear appeal (Group 1) and (b) Treatment as usual (TAU, Group 2). Group 1 will receive TAU, along with PFI, and fear appeal, using a video recording of their own delirium symptoms. Intervention will focus on the harmful consequences of alcohol use, aiming to reduce consumption and increase abstinence duration. Group 2 will receive standard pharmacological treatment, along with motivational enhancement therapy (MET) or relapse prevention therapy (RPT).

Expected Outcome:

Outcomes will be measured through Timeline Follow Back (TLFB) for alcohol consumption and duration of abstinence, with follow-ups at 1 and 3 months.

Key Messages:

• Personalized feedback with fear appeal may reduce alcohol consumption and increase abstinence in alcohol-induced delirium.

• Combining fear-based interventions with motivational enhancement therapy (MET) or relapse prevention therapy (RPT) may offer a promising approach to treating alcohol dependence.

Alcohol is the most common psychoactive substance consumed by Indians, and nationally, about 14.6% of the population uses alcohol, out of which the prevalence of a dependent pattern of alcohol use is estimated to be 2.7%. In Telangana, 16.8% of the population consumes alcohol, and the prevalence of a dependent pattern of alcohol consumption is 1.8%. ¹ Progression to an acute state of impaired consciousness known as alcohol-induced delirium can significantly increase the morbidity and mortality of the patients. ² Clinical studies have shown that a history of multiple detoxification attempts increases an individual’s susceptibility to more severe and complicated withdrawals in the future. ³ In addition to pharmacotherapy, the most commonly and effectively used behavioral interventions include motivational interviewing, motivational enhancement therapy (MET), and cognitive behavioral therapy, along with feedback in the form of biochemical tests. ⁴

Literature Review

Despite the availability of established interventions, achieving long-term abstinence remains a significant challenge for many individuals. ⁵ A new strategy that has been followed lately by the health care providers involves the use of personalized feedback interventions (PFIs) with fear appeal (e.g., messages that present threatening information about potential health hazards to emphasize the harmful consequences of risky behaviors). In such cases, fear acts as a motivational force, prompting individuals to seek protective responses and comply with recommended actions—an element that is often missing in traditional treatment modalities. ⁶ Current evidence has not demonstrated any harmful consequences arising from the use of fear as feedback. ⁷ The concept of fear appeal communications (e.g., videotape about smoking hazards) and the use of PFI (e.g., biochemical tests of the individuals) have been tried separately with improved effectiveness.^8,9

Novelty

To date, only one study, which was conducted outside of India, has evaluated the relapse rates by showing videotapes of themselves while experiencing alcohol-induced delirium. It has been shown to reduce relapse rates by improving awareness and overcoming the obstacle caused by amnesia during the delirium. ¹⁰ Also, a case series from India with a similar intervention had shown an increase in the period of abstinence. ¹¹ Thus, the current study intends to evaluate the impact of both PFI, which includes biochemical, radiological, behavioral, and social aspects, along with fear appeal, by using videotapes of patients themselves while in delirium in reducing alcohol consumption and increasing the duration of abstinence.

Objectives

The primary objective of this study is to compare the changes in the alcohol consumption pattern, in terms of duration of abstinence and amount of alcohol consumption, between individuals with alcohol-induced delirium receiving PFI with fear appeal and treatment as usual (TAU). The secondary objectives include: (a) To assess for predictors of response to PFI with fear appeal, such as sociodemographic and clinical variables, and (b) to assess attitude toward drinking and alcohol as predictors of response to PFI with fear appeal.

Methodology

Study Design/Study Participants/Setting

The study will employ a two-arm open-label randomized controlled trial to study the effect of PFI with fear appeal on alcohol consumption patterns in patients with alcohol-induced delirium. Individuals admitted to the inpatient facility at AIIMS Bibinagar, diagnosed with alcohol-induced delirium (International Classification of Diseases, 11th Edition [ICD-11]), would be recruited based on the inclusion criteria: ¹² (a) Age ≥18 years and any gender, (b) a score of ≥15 for males and ≥13 for females on the Alcohol Use Disorder Identification Test (AUDIT), ¹³ and (c) a Richmond Agitation and Sedation Scale (RASS) score of ≥ +3 will be included; hypoactive delirium will not be considered. ¹⁴ Presence of any comorbid medical conditions, such as acute pancreatitis or acute hepatitis, is recorded as a separate clinical variable. On the other hand, patients currently suffering from any other comorbid psychotic disorder or the presence of any major cognitive disorder, intellectual disability, or known substance dependence (except nicotine) will be excluded from the study. Purposive sampling will be done to recruit the cases. Patients will be randomized into two groups using fixed block randomization (block of 4). Allocation using opaque, sealed envelopes will be conducted by a person not involved in delivering the intervention or rating. The two arms will be PFI with fear appeal plus TAU (Group 1) and TAU (Group 2).

Sample Size

Sample size has been estimated based on the 3-month relapse rates observed for patients with videotape experience (i.e., 26.66%), ⁵ and an additional reduction with the PFI of 6.66%^10,15 and average rates of relapse in alcohol dependence patients in India of 60%. ¹⁶ Based on the formula “(Z_α + Z_β)² * (P₁(100 – P₁) + P₂(100 – P₂)) / (P₁ – P₂)²,” where P₁ is 20 (26.66 − 6.66), P₂ is 60, Z_α = 1.96 (α = 5%), Z_β = 0.842 (β = 20%; 1 − β i.e., power = 80%), the estimated sample size is 20. With a 20% dropout rate, the final estimated sample size is 24 per group. Consequently, a total of 48 patients will be recruited.

Tools and Instruments

Specifically designed sociodemographic and clinical proformas will be used. The following tools will be used in the study:

The AUDIT was used as a tool for recording clinical characteristics with respect to drinking and detecting harmful drinking patterns for the past 12 months. Each question is scored from 0 to 4, and the total score ranges from 0 to 40. A score of 15 or more in males and 13 or more in females indicates likely alcohol dependence. ¹³

The Clinical Institute Withdrawal Assessment for Alcohol–Revised (CIWA-Ar) is a 10-item scale used to assess the severity of alcohol withdrawal. A score below 10 indicates mild withdrawal; between 10 and 20, moderate withdrawal; and above 20, severe withdrawal. ¹⁷

The RASS score is a 10-point scale ranging from –5 to +4 to demonstrate fluctuating levels of consciousness. Scores from –1 to –5 indicate varying levels of sedation, and between +1 to +4 describe increasing levels of agitation. ¹⁴

The Timeline Follow Back (TLFB) is a calendar-based method for estimating daily alcohol consumption over time. Patients are asked to record the quantity of alcohol consumed on each day of the calendar within the defined time period. ¹⁸

The Scale for Assessment of Attitude toward Drinking and Alcoholism–Second Version (SAADA-II) is a 29-item Likert-type scale to assess the attitude of the patient toward alcohol. It consists of four factors: Acceptance, rejection, avoidance, and social dimension. ¹⁹

As part of the routine evaluation, investigations such as complete blood count, liver function test, renal function test, serum electrolytes, and abdominal ultrasonography will be performed.

Outcomes-Primary

1. The overall estimation of the individual’s daily alcohol consumption over a period of 3 months using TLFB.

2. Duration of abstinence, which is defined as the discontinuation or the practice of self-enforced restraint from indulging in activities that are widely experienced as giving pleasure. It will be assessed as the number of days of abstinence from discharge to the follow up assessment. If any lapses are reported, those days will be subtracted from the number of days the patients remained abstinent.

Implementation Plan

The study will be conducted in the Department of Psychiatry, AIIMS Bibinagar, and approval from the Institute Research Committee (Ref:AIIMS/ BBN/ResCell/IRC/2024/498) and the Institute Ethics Committee (Ref:AIIMS/BBN/IEC/MAY/2024/439) has been obtained, and the trial is registered with the Clinical Trials Registry–India (Ref:CTRI/202/06/086974). All the individuals who fulfill the inclusion criteria will be approached for the study. As the patients will be in delirium during the inclusion period, informed consent will be obtained from a legally authorized representative. Capacity assessment for all patients is routinely performed using the “Capacity Assessment for Treatment Decisions” (Form 1, Mental Healthcare Act) at weekly intervals. Once the patient regains sustained and complete consciousness (CIWA-Ar score of 0), the consent process is revisited to confirm their understanding and agreement. Sociodemographic and clinical details will be noted. Alcohol-induced delirium will be diagnosed based on the ICD-11 diagnostic criteria of 6C40.5. Participants will be allocated to 1 of 2 groups using fixed block randomization. Subjects in Group 1 will receive both PFI with fear appeal and TAU, whereas subjects in Group 2 will receive only TAU.

Intervention

Patients will be recruited in two arms: a) PFI with fear appeal plus TAU, and b) TAU.

PFI with fear appeal [Table 1].

Table 1.

Various Tasks Followed in PFI with the Fear Appeal Group.

Phase of Treatment	Tasks
Day of admission	• Sociodemographic and clinical proforma. • Informed consent from a legally authorized representative (relative). • Baseline investigations. • Scales: AUDIT, CIWA-Ar, RASS. • One 5-minute continuous video will be recorded for each patient during the period when they are experiencing delirium, by the principal investigator (PI) or any medical staff trained in the same, in case the PI is not available. A video will be recorded during the first point of contact between the patient and the PI, when the patient is in delirium. • The video will capture the patient’s symptoms during alcohol-induced delirium, including hallucinatory behavior, motor restlessness, aggressive behavior toward family and staff, behavior during assessments, and during physical restraint processes when needed. • Videos were recorded using a phone with a 48-megapixel ultra-wide camera, and the videos were of 2,160 × 3,840 pixels (4K UHD) resolution.
Pharmacological management	Benzodiazepines • 12–24 mg Lorazepam equivalents. • Choice of benzodiazepine will be based on the patient’s characteristics. • Symptom-triggered regimen used. Thiamine • Parenteral thiamine supplements (1,200–1,500 mg) for 5 days. • Followed by oral supplementation (300–600 mg). Antipsychotics, if needed (Parenteral Haloperidol 5 mg given on SOS basis) An anti-craving/aversive agent will be chosen based on the patient’s suitability and preference.
Non-pharmacological management (post resolution of delirium)	Informed consent from the patient.
	Day 1 (30 minutes).	Description regarding the overall course of stay in hospital, plus discussion regarding the results of baseline assessment tests.
	Day 2 (30 minutes).	Session 1 of MET/RPT (based on individual requirement).
	Day 3 (15–30 minutes).	Network therapy: Caregivers are educated about delirium, which helps in its treatment and prevention.
	Day 4 (30 minutes).	Session 2 of MET/RPT.
	Day 5 (15–30 minutes).	Educate the patient regarding problems in interpersonal relationships, occupation due to alcohol use, and legal issues associated with it.
	Pre-discharge (15–20 minutes)	“Fear appeal” session: • Before starting this session, the patient will be asked about their recall during the period of delirium, as the patient might be amnestic for some periods. • Before the intervention, the patient is provided with the information regarding delirium, which is a life-threatening complication of alcohol use, and the possibility of further recurrent episodes if the patient continues to consume alcohol. • Patient will be informed regarding the recording of their video during delirium. • After obtaining consent and readiness from the patient, the recorded video will be shown with the instruction: “Please watch the video carefully and specifically note your behaviors throughout the video.” • After the patient completes watching the video, they will be asked, “What do u feel about it?” At this moment, the therapist notes the patient’s emotional reaction. • Explanation regarding the patient’s behavior in the video will be discussed. • Information provided during the session will be based on establishing the connection between the symptoms experienced by the patient and their relation to alcohol. • Additionally, the feedback regarding any abnormalities in the baseline assessments will also be discussed.
Follow up	1 month	• “Fear appeal” session. • Session 3 of MET/RPT (15–20 minutes). • Assess the duration of abstinence. • TLFB.
	3 months	• “Fear appeal” session. • Session 4 of MET/RPT (15–20 minutes). • Assess the duration of abstinence. • TLFB. • SAADA-II.

AUDIT–Alcohol use disorder identification test, CIWA-Ar–Clinical institute withdrawal assessment for alcohol–revised, RASS–Richmond agitation and sedation scale, MET–Motivational enhancement therapy, RPT–Relapse prevention therapy, TLFB–Timeline follow back, SAADA-II–Scale for assessment of attitude toward drinking and alcoholism–second version, UHD-Ultra High Definition.

Table 2.

Various Tasks Followed in Treatment as Usual Group.

Phase of Treatment	Tasks
Day of admission	• Sociodemographic and clinical proforma. • Informed consent from a legally authorized representative (relative). • Baseline investigations. • Scales: AUDIT, CIWA-Ar, RASS.
Pharmacological management	Benzodiazepines • 12–24 mg lorazepam equivalents. • Choice of benzodiazepine will be based on the patient’s characteristics. • Symptom-triggered regimen used. Thiamine • Parenteral thiamine supplements (1,200–1,500 mg) for 5 days. • Followed by oral supplementation (300–600 mg). Antipsychotics if needed (parenteral haloperidol 5 mg given on SOS basis) An anti-craving/aversive agent will be chosen based on the patient’s suitability and choice.
Non-pharmacological management (post resolution of delirium)	Informed consent from the patient.
	Day 1 (30 minutes).	Description regarding the overall course of stay in hospital, plus discussion regarding the results of baseline assessment tests.
	Day 2 (30 minutes).	Session 1 of MET/RPT (based on individual requirement).
	Day 3 (15–30 minutes).	Network therapy: Caregivers are educated about delirium, which helps in its treatment and prevention.
	Day 4 (30 minutes).	Session 2 of MET/RPT.
	Day 5 (15–30 minutes).	Educate the patient regarding problems in interpersonal relationships, occupation due to alcohol use, and legal issues associated with it.
Follow up	1 month	• Session 3 of MET/RPT (15–20 minutes). • Assess the duration of abstinence. • TLFB.
	3 months	• Session 4 of MET/RPT (15–20 minutes). • Assess the duration of abstinence. • TLFB. • SAADA-II.

AUDIT–Alcohol use disorder identification test, CIWA-Ar–Clinical institute withdrawal assessment for alcohol–revised, RASS–Richmond agitation and sedation scale, MET– Motivational enhancement therapy, RPT–Relapse prevention therapy, TLFB–Timeline follow back, SAADA-II–Scale for assessment of attitude toward drinking and alcoholism–second version.

Ethics Review

Written informed consent will be obtained from the legally authorized representative at the time of inclusion, as the patient would be in a state of delirium. Consent from the patient will be obtained before the pre-discharge intervention begins. If the patient refuses consent, the participant will be excluded from the study, and the video will be deleted. The consent process complies with the Mental Health Care Act 2017. Confidentiality regarding the patient’s identity will be maintained. All videotapes taken during the study will not be shared, will be under the principal investigator’s custody, and will be destroyed at the end of the feedback sessions.

Statistical Analysis Plan

Initially, normality tests will be applied. Accordingly, the choice for parametric and non-parametric tests will be made. Comparison of demographic and clinical variables between the two groups will be performed using the t test, Mann–Whitney U test, and chi-square test. Analysis will be performed using a repeated-measures Analysis of Variance (ANOVA) or a Friedman test. Regression analysis will be used to assess predictors.

Timelines

Patient will be followed up at 1 month and 3 months, respectively, either in person or through teleconsultation. Post-interventional assessment includes evaluating the amount of alcohol consumption using TLFB, duration of abstinence, assessing the predictors of response to PFI, and attitude change in patients toward alcohol using SAADA-II [Figure 1].

Figure 1. Consort Diagram.

PFI–Personalized feedback intervention, TAU–Treatment as usual

Discussion

Alcohol dependence represents a significant public health challenge, primarily due to its widespread prevalence among adults and the high rates of relapse seen even with the availability of comprehensive treatment options. ³

In addition to traditional therapies, fear-based interventions can be a powerful tool for influencing behavior change and maintaining abstinence by integrating emotional and cognitive neural mechanisms. The findings from an functional Magnetic Resonance Imaging (fMRI) analysis demonstrated that a fear appeal intervention leads to increased activation in the anterior cingulate cortex and the ventromedial prefrontal cortex, which help the individual become aware of the potential dangers associated with drinking and support behavioral regulation. Enhanced activation in the amygdala, orbitofrontal cortex, thalamus, and insula supports prior evidence linking these regions to emotional arousal and affective appraisal of fear-related stimuli. Moreover, activation of the hippocampus, medial temporal lobe, and precuneus indicates that fear appeal imagery enhances episodic memory encoding and retrieval during cravings, thereby helping maintain abstinence. This integrated activation underscores the neurobiological basis of how fear-based interventions lead to behavioral change. ²⁰

Two key models that explain the effectiveness of fear appeals are the Extended Parallel Process Model (EPPM) and Terror Management Theory (TMT). EPPM suggests that fear appeals are effective when they balance perceived threat with perceived efficacy, motivating protective actions. Overwhelming fear without a clear solution can lead to maladaptive responses. It remains a key framework for understanding and improving the effectiveness of fear-based interventions [Figure 2]. ²¹ TMT explains that fear appeals involving death-related consequences (e.g., death from drinking and driving) may backfire for individuals strongly committed to alcohol use. The fear of death triggers existential anxiety, leading to defensive reactions such as denial or avoidance. In contrast, fear appeals emphasizing non-death consequences (e.g., arrest or injury) are more likely to be accepted, as they avoid intense existential anxiety and allow for behavior change [Figure 3]. ²² An additional enhancement to this strategy involves personalizing the feedback (in the form of videotape) along with personalized narratives about the progression of alcohol-related health complications.

Figure 2. Extended Parallel Process Model.

Figure 3. Terror Management Theory.

Expected Strengths

The randomized controlled study design enables a robust comparison between the intervention and TAU, particularly in contexts where existing evidence is limited to case series or studies conducted outside India. The target population of alcohol-related delirium, which is considered a life-threatening condition and is addressed in the study, faces clinically relevant challenges such as impaired insight and amnesia. The use of standardized, validated instruments (AUDIT, CIWA-Ar, RASS, TFLB, SAADA-II) strengthens the reliability of the findings. Moreover, the intervention’s fear appeal component, which uses available devices to record videos, eliminates the need for additional training or specialized equipment. This makes the intervention both cost-effective and easy to implement in clinical settings.

Expected Limitations

The study being conducted at a single tertiary center may limit the generalizability of the findings across different healthcare settings. As it is an open-label trial, it may introduce bias, especially in self-reported outcomes such as alcohol consumption patterns. The smaller sample size, while adequate for detecting the primary outcome, may reduce the power of subgroup analyses. The duration of follow up period of about 3 months may be insufficient to look into the long-term relapses and abstinence periods.

Expected Outcomes

The participants receiving PFI with fear appeal in addition to TAU are expected to show a reduction in either quantity or frequency of alcohol consumption over the 3 month follow up period, which is measured by TLFB when compared to those receiving only TAU. Additionally, the intervention group is likely to demonstrate longer abstinence and fewer relapses. Furthermore, the intervention is expected to bring about positive changes in attitudes toward alcohol, which will be shown by increased scores in rejection and avoidance domains, and decreased acceptance scores on the SAADA-II scale. Our study also expects to identify sociodemographic and clinical predictors of treatment response, such as age, severity of withdrawal, and other relevant factors.