An observational study in Substance-Related Disorders and Substance Use Disorders, sponsored by Under The Tree Therapeutic Community. Active, not recruiting at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Under The Tree Therapeutic Community · Observational
Recovery from substance use disorders (SUD) unfolds within individual, interpersonal and environmental contexts. In therapeutic communities, social support, participation and community climate may be part of the pathway through which psychological change relates to functioning during treatment. This prospective, observational, longitudinal cohort study of people in residential SUD treatment will test a sequential mediation model in which helplessness precedes behavioral avoidance, avoidance is related to lower environmental reward, and lower environmental reward is in turn associated with more frequent negative automatic thoughts.
The study will also examine whether community context modifies the association between avoidance and environmental reward, and whether psychological flexibility is independently associated with environmental reward and negative automatic thoughts.
Participants will be assessed weekly during residential treatment with validated self-report instruments and periodic written narratives. Repeated observations are nested within participants and are analyzed with multilevel models that separate within-person from between-person effects, using prespecified time lags (helplessness at time t, avoidance at t+1, environmental reward at t+2, negative automatic thoughts at t+3). No intervention is assigned and the community context is not manipulated.
BACKGROUND Psychological flexibility and inflexibility have been proposed as transdiagnostic processes in SUD. In therapeutic communities, the social environment is a relevant component of recovery, but how individual processes and community context jointly operate over time remains insufficiently studied with designs that respect the nested structure of repeated observations.
OBJECTIVES Primary: to evaluate longitudinally the sequential mediation chain helplessness -> avoidance -> environmental reward -> negative automatic thoughts during residential treatment. Secondary: (1) estimate within-person associations between chain components controlling for stable between-person differences and time in treatment; (2) test whether community context modifies the avoidance-to-environmental-reward path; (3) examine the independent association of psychological flexibility with environmental reward and negative automatic thoughts; (4) evaluate convergent and discriminant validity of language-derived indicators; (5) determine the feasibility and stability of longitudinal collection of narratives and psychometric measures.
DESIGN Prospective observational cohort with weekly repeated measures. Level 1 is repeated measurements within participant, level 2 is participant and, where applicable, level 3 is center. Assessments cover helplessness, avoidance (Behavioral Activation for Depression Scale, avoidance/rumination subscale), environmental reward (Environmental Reward Observation Scale), negative automatic thoughts (Automatic Thoughts Questionnaire-8), community context, psychological flexibility, anxiety symptoms (GAD-7) and periodic written narratives. Indicators derived from narratives by natural language processing are treated as computationally derived variables, not as validated psychometric instruments, and their pipeline is frozen before confirmatory analysis.
ANALYSIS The primary analysis is a multilevel longitudinal sequential mediation model with prespecified lags. The indirect effect is the product of paths a1, a2 and b, with Monte Carlo confidence intervals and a cluster bootstrap as sensitivity analysis. Missing data are handled with maximum likelihood or multiple imputation. H1 is the only primary hypothesis; H2 and H3 are secondary confirmatory hypotheses with Holm correction. Machine learning and other exploratory analyses are kept separate from the confirmatory analysis.
SAMPLE SIZE Sample size is determined by Monte Carlo simulation of the primary model, using historical data only to parameterize the simulation, not as confirmatory evidence.
DATA PROTECTION Direct identifiers are stored separately from the analytic dataset. Narratives are de-identified before any transfer to external computational environments. Identifiable clinical data and original narratives are not placed in public repositories.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 80 is below the median of 251 across 299 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Under The Tree Therapeutic Community is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
People in residential treatment for substance use disorders at participating therapeutic communities [sites to be specified].
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults admitted to residential substance use disorder treatment in participating therapeutic communities who consent to weekly assessments and use of their written narratives for research. Single cohort followed from admission to discharge. No intervention is assigned by the study.
Other: Routine residential therapeutic community treatment (not assigned by the study)
Usual treatment delivered by the community. The study does not assign or modify it and does not manipulate the community context.
Sequential indirect effect of helplessness on negative automatic thoughts through avoidance and environmental reward (IE = a1 × a2 × b)
Within-person sequential indirect effect estimated in a multilevel longitudinal mediation model: helplessness at week t (X), avoidance at week t+1 (M1; Behavioral Activation for Depression Scale, avoidance/rumination subscale), environmental reward at week t+2 (M2; Environmental Reward Observation Scale), and negative automatic thoughts at week t+3 (Y; Automatic Thoughts Questionnaire-8). The effect is the product of paths a1, a2, and b, reported with a Monte Carlo confidence interval. Within-person and between-person effects are estimated separately.
Time frame: Weekly assessments from baseline through week 8, with additional weekly assessments through study completion for participants remaining in the study beyond week 8.
Moderation of the avoidance-to-environmental-reward path by community context
Interaction between avoidance at week t+1 and community context at week t predicting environmental reward at week t+2, measured using the Environmental Reward Observation Scale (EROS). The EROS consists of 10 items, each scored from 1 to 4, yielding a total score ranging from 10 to 40 points. Higher scores indicate greater perceived environmental reward and therefore represent a better outcome. The interaction coefficient will quantify whether community context moderates the within-person relationship between avoidance and subsequent environmental reward. Measurement Unit: Regression interaction coefficient (β), representing the change in the avoidance-to-environmental-reward relationship associated with community context.
Time frame: Baseline and weekly assessments through Week 8; additional weekly assessments through study completion (anticipated mean follow-up duration to be specified).
Within-person and between-person effects of psychological flexibility on environmental reward (Environmental Reward Observation Scale; EROS)
Multilevel longitudinal regression coefficients estimating the within-person and between-person effects of psychological flexibility, measured using \[name of psychological flexibility questionnaire\], on environmental reward measured using the Environmental Reward Observation Scale (EROS). The EROS consists of 10 items, each scored from 1 to 4, yielding a total score ranging from 10 to 40 points. Higher scores indicate greater perceived environmental reward and therefore represent a better outcome. Within-person and between-person effects of psychological flexibility will be estimated separately.
Time frame: Baseline and assessments every 2 weeks through Week 8; additional assessments every 2 weeks through study completion (anticipated mean follow-up duration to be specified).
Within-person and between-person effects of psychological flexibility on negative automatic thoughts (Automatic Thoughts Questionnaire-8; ATQ-8)
Multilevel longitudinal regression coefficients estimating the within-person and between-person effects of psychological flexibility, measured using \[name of psychological flexibility questionnaire\], on negative automatic thoughts measured using the Automatic Thoughts Questionnaire-8 (ATQ-8). The ATQ-8 consists of 8 items, each scored from 1 to 5, yielding a total score ranging from 8 to 40 points. Higher scores indicate greater frequency or intensity of negative automatic thoughts and therefore represent a worse outcome. Within-person and between-person effects of psychological flexibility will be estimated separately.
Time frame: Baseline and assessments every 2 weeks through Week 8; additional assessments every 2 weeks through study completion (anticipated mean follow-up duration to be specified).
Convergent and discriminant validity of language-derived indicators of helplessness and psychological flexibility
Pearson correlation coefficients (r) or Spearman rank correlation coefficients (ρ), as appropriate, between natural language processing (NLP)-derived indicators of helplessness and psychological flexibility extracted from weekly written narratives and their corresponding questionnaire scores. Correlation coefficients will be reported separately for each construct. Additional correlations with prespecified surface text features (including narrative length and lexical characteristics) will be examined to assess the extent to which language-derived indicators depend on superficial textual properties. Measurement Units: Correlation coefficients (r or ρ), ranging from -1 to +1.
Time frame: Weekly assessments from baseline through Week 8, with additional weekly assessments through study completion (anticipated mean follow-up duration to be specified).
Anxiety symptoms (Generalized Anxiety Disorder-7; GAD-7)
Total score on the Generalized Anxiety Disorder 7-item scale (GAD-7), used as a covariate in longitudinal analyses and as a secondary outcome measure. The scale consists of 7 items, each scored from 0 to 3, yielding a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity and therefore represent a worse outcome.
Time frame: Baseline and assessments every 2 weeks through Week 8, with additional assessments every 2 weeks through study completion (anticipated mean follow-up duration to be specified).
Plan to share: Yes — Individual participant data, including clinical narratives, will not be shared because of confidentiality. When possible, the protocol, analysis code, data dictionary, provenance documentation, sample size simulations and reproducible aggregate results will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Oct 2027, 21 months after the start.
Of 122 non-industry observational studies under Substance-Related Disorders, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 21 months is below that.
Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 18 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Under The Tree Therapeutic Community