Recruiting NA Study Protocol Feasibility

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Official title Effects of Darkness Retreat: a Pilot Study

ClinicalTrials.gov ID: NCT07429617

What this study is testing

What it's testing
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.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 30 to 50. Healthy volunteers may be eligible.

You may be able to join if

  • 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...
  • Preliminary verification of these criteria will be carried out using a screening questionnaire containing demographic questions and items regarding...
  • PSWQ: 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)
See the full eligibility criteria
Who can join
  • 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...
  • 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...
  • PSWQ: 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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).

The study team makes the final eligibility decision.

Where it's taking place

  • Poznan, Wielkopolska, Poland
  • Poznan, Poland

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 30 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Poznan, Wielkopolska, Poland; Poznan, Poland. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.