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Recruiting NCT07429617

Effects of Darkness Retreat: a Pilot Study

No phase Interventional Study Protocol Feasibility Non Clinical Anxiety Non Clinical Worry Non Clinical Rumination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Darkness Retreat - Several Days of Seclusion in Complete Darkness.
Who it may be relevant to
Registry conditions: Study Protocol Feasibility, Non Clinical Anxiety, Non Clinical Worry, Non Clinical Rumination. Basic parameters: 30 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Darkness Retreat on Worry and Rumination in a Non-clinical Population: a Pilot Study

Overview

The primary goal of this pilot study is to test the feasibility and safety of a research protocol for a voluntary darkness retreat. The study will also allow for a preliminary examination of the psychological effects of the retreat. The investigators will investigate whether participants experience changes in their well-being and ruminative style, whether these changes persist over time, and if these effects are moderated by individual characteristics such as readiness for change or subjective evaluation of the experience as well as frequency of participants' monitoring. Participants will be randomly assigned to one of two experimental groups, both of which will spend 3 days and 3 nights in seclusion. These groups will differ only in the frequency of psychological monitoring during the retreat, allowing us to compare the effectiveness and safety of each protocol.

Detailed description

The aim of the pilot study is to test a research protocol designed to assess the psychological effects of several days of voluntary darkness retreat. The primary objective of the pilot is to examine whether the protocol is feasible, implementable, and safe under real-world conditions when working with a non-clinical population. Our sample will consist of 30 psychologically healthy students aged 30-50 with higher levels of trait anxiety and worry. Participants will be randomly assigned to one of the two conditions: (1) Low-frequency monitoring: one structured psychological consultation per day (one full psychological consultation per day) (2) High-frequency monitoring: three consultations per day (one full consultation + two shorter check-ins).

The trial will also provide preliminary data on whether participating in a darkness retreat is associated with any changes in well-being and ruminative thought style. The investigators will examine if changes are observed in the levels of anxiety, ruminative style, worry, mindfulness, and a sense of meaning in life, if those changes differentiate accordingly to the monitoring frequency (high monitoring vs. low monitoring), and if those changes persist over time (at the 6-month follow-up).

The study uses a 2 × 3 mixed factorial design with two intervention arms (low-frequency vs. high-frequency monitoring) and three measurement time points: T1 - just prior to the intervention, T2 - immediately after the intervention, and T3 - six-month follow-up. The primary intervention lasts three days and three nights. All primary and secondary outcomes are assessed using self-administered online questionnaires in Polish. Each primary outcome measure will be analyzed using 2 (arms) × 3 (time points) ANOVA models to test for the short- and long-term intervention effects. Additional analyses will use standard NHST procedures (e.g., t-tests and correlation coefficients) with a conventional significance level of α = .05.

During the study, participants will not be informed that its primary aim is to compare two variants of the psychological monitoring protocol. This information will be withheld to minimize the risk of expectancy effects. To ensure the highest ethical standards, a debriefing procedure will be carried out after the study has been completed.

Interventions

  • Other Darkness Retreat - Several Days of Seclusion in Complete Darkness
    The intervention is a voluntary darkness retreat involving three days and three nights of continuous seclusion in a completely dark cabin, with no access to external light sources or electronic devices. During the retreat, participants are consulted about their well-being through a standardized interview protocol, with consultation frequency determined by their assigned group. Participants in both groups will be equipped with WHOOP wristbands - devices monitoring physiological activity. These wr

Primary outcome measures

  • Study Protocol Feasibility [Time frame: From recruitment start until completion of the six-month follow-up.]
  • Penn State Worry Questionnaire Score Change [Time frame: Time point 1: Just prior to the intervention. Time point 2: Immediately after the intervention. Time point 3: Six months after the previous measurement (time point 2).]
Secondary outcome measures (8)
  • CESD-R Score Change [Time frame: Time point 1: Just prior to the intervention. Time point 2: Immediately after the intervention. Time point 3: Six months after the previous measurement (time point 2).]
  • State-Trait Anxiety Inventory Score Change [Time frame: Time point 1: Just prior to the intervention. Time point 2: Immediately after the intervention. Time point 3: Six months after the previous measurement (time point 2).]
  • Abbreviated Five Facet Mindfulness Questionnaire Score Change [Time frame: Time point 1: Just prior to the intervention. Time point 2: Immediately after the intervention. Time point 3: Six months after the previous measurement (time point 2).]
  • Ruminative Thoughts Questionnaire Score Change [Time frame: Time point 1: Just prior to the intervention. Time point 2: Immediately after f the intervention. Time point 3: Six months after the previous measurement (time point 2).]
  • Meaning in Life Questionnaire Score Change [Time frame: Time point 1: Just prior to the intervention. Time point 2: Immediately after the intervention. Time point 3: Six months after the previous measurement (time point 2).]
  • Self-Compassion Scale - Short Form Score Change [Time frame: Time point 1: Just prior to the intervention. Time point 2: Immediately after the intervention. Time point 3: Six months after the previous measurement (time point 2).]
  • Post-Traumatic Growth Score Change [Time frame: Time point 2: Immediately after the intervention. Time point 3: Six months after the previous measurement (time point 2).]
  • Go / no - go Test Change [Time frame: Time point 1: Just prior to the intervention. Time point 2: Immediately after the intervention. Time point 3: Six months after the previous measurement (time point 2).]

Eligibility criteria

Participants will be recruited from university/postgraduate students through a two-stage process.

Stage I. Individuals expressing interest in participation will be asked to confirm that they are not currently engaged in psychotherapy or coaching, are not taking psychotropic medication, and are in generally good physical health. The following individuals will be excluded from the study: those diagnosed with an acute or chronic somatic illness (e.g., cardiovascular disease); psychiatric or neurological disorders (e.g., depression, addiction, bipolar disorder, schizophrenia, epilepsy, stroke, severe brain injury, Parkinson's disease, Alzheimer's disease or other forms of dementia); those exhibiting active suicidal tendencies with a plan or intent; those taking psychotropic medication; engaged in psychotherapy or coaching; and pregnant individuals.

Preliminary verification of these criteria will be carried out using a screening questionnaire containing demographic questions and items regarding psychotherapy/coaching, use of psychoactive medication, somatic health, suicidal tendencies, pregnancy, and confirmation of a history of diagnoses in the categories of psychotic disorders, eating disorders, obsessive-compulsive disorder, substance use disorders, bipolar disorder, along with the following questionnaires:

PSWQ: Inclusion criteria based on the PSWQ (Penn State Worry Questionnaire, range 16-80, higher scores indicating worse functioning):

Participants must obtain a total score between 40 and 80. (40-59 = moderate level of worry/anxiety) (60-80 = high level of worry/anxiety)

In cases where participants fall within the high range, if clinical levels of worry are identified during the clinical interview, they will be excluded from participation.

PAtient Health Questionnaire-9 (PHQ-9, range 0-27, higher scores indicating worse functioning): Individuals scoring above 10 will be considered at elevated risk for depression, and those scoring 20 or higher will not be invited to the clinical interview.

Generalized Anxiety Disorder-7 (GAD-7, range 0-21, higher scores indicating worse functioning): Individuals scoring 7 or higher will be classified as having elevated generalized anxiety symptoms, and those scoring 15 or higher will be excluded from further participation.

Alcohol Use Disorders Identification Test (AUDIT, range 0-40, higher scores indicating worse functioning): Individuals scoring above 8 will be considered at elevated risk for problematic drinking, and those scoring 22 or higher will not be invited to the clinical interview.

Drug Use Disorders Identification Test (DUDIT, range 0-44, higher scores indicating worse functioning): Individuals scoring above 4 will be classified as at elevated risk for substance use, and those scoring 7 or higher will be excluded.

The questionnaire will also include the following measures, which will not be used for automatic exclusion but will indicate the need for further evaluation during the clinical interview if the following thresholds are met:

DSM-5 - Panic Disorder (range 0-40, higher scores indicating worse functioning): score ≥ 26 DSM-5 - Social Anxiety Disorder (range 0-40, higher scores indicating worse functioning): score ≥ 26 DSM-5 - Post-Traumatic Stress Disorder (range 0-44, higher scores indicating worse functioning): score > 22

Only individuals who are not excluded based on the above criteria will be invited to the next stage.

Stage II. Candidates meeting the preliminary criteria will be invited to an online clinical interview with a psychologist. Approximately one week before the scheduled interview, participants will receive via email a link to the Personality Beliefs Questionnaire (PBQ; Zawadzki et al., 2017), that would help in a more in-depth assessment of psychological functioning during the actual meeting. In order to exclude clinical cases, the psychologist will use the structured clinical interview M.I.N.I. (Mini International Neuropsychiatric Interview)

Participants who complete the psychological interview-regardless of their final qualification for the study-will receive a compensation of approximately 200 ZŁ in shopping vouchers (50EUR).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Poland · 2 centers
  • Poznań Laboratory of Affective Neuroscience, Institute of Psychology, SWPS University, War — Poznan
  • SWPS University of Social Sciences and Humanities — Poznan

Publications

  • Solarikova P, Bartolen I. Effects of chamber restricted environmental stimulation therapy on state mindfulness, physiological regulation and emotional experience in young adults: Exploring variations by resting heart rate variability. Acta Psychol (Amst). 2025 Mar;253:104697. doi: 10.1016/j.actpsy.2025.104697. Epub 2025 Jan 10. PMID 39798490
  • Hruby H, Schmidt S, Feinstein JS, Wittmann M. Induction of altered states of consciousness during Floatation-REST is associated with the dissolution of body boundaries and the distortion of subjective time. Sci Rep. 2024 Apr 23;14(1):9316. doi: 10.1038/s41598-024-59642-y. PMID 38654027
  • Flux MC, Fine TH, Poplin T, Al Zoubi O, Schoenhals WA, Schettler J, Refai HH, Naegele J, Wohlrab C, Yeh HW, Lowry CA, Levine JC, Smith R, Khalsa SS, Feinstein JS. Exploring the acute cardiovascular effects of Floatation-REST. Front Neurosci. 2022 Dec 9;16:995594. doi: 10.3389/fnins.2022.995594. eCollection 2022. PMID 36570829
  • Feinstein JS, Khalsa SS, Yeh H, Al Zoubi O, Arevian AC, Wohlrab C, Pantino MK, Cartmell LJ, Simmons WK, Stein MB, Paulus MP. The Elicitation of Relaxation and Interoceptive Awareness Using Floatation Therapy in Individuals With High Anxiety Sensitivity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):555-562. doi: 10.1016/j.bpsc.2018.02.005. Epub 2018 Mar 9. PMID 29656950

Identifiers

NCT: NCT07429617 · SWPS_Retreat_RCT_1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗