- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07697001
Clinical and Neurocomputational Effects of Behavioral Activation in Veterans With Impaired Social Functioning
Přehled studie
Postavení
Detailní popis
Perceived social disconnection and social isolation are disabling and common among Veterans. Yet, these psychosocial impairments can fail to improve following the best available evidence-based treatments. Behavioral activation (BA), an evidence-based treatment for depression has shown promise in improving social functioning. However, most of this research was conducted in primarily non-Veteran populations and has typically relied on patients' subjective symptoms and self-report, in contrast to objective behavioral probes, to assess social functioning. Moreover, the cognitive mechanisms promoting social behavior remain poorly understood, particularly in Veterans. For instance, social anhedonia, i.e., a reduced sensitivity to social rewards, such as positive human interactions, has been implicated as an important driving mechanism of poor social functioning. Yet, the degree to which BA successfully target social reward sensitivity remains unclear and has not been evaluated in Veterans. This lack of understanding limits the ability to develop more targeted and effective interventions for psychosocial recovery. To address these gaps, this study aims to test the clinical and neurobehavioral effectiveness of BA in targeting social dysfunction in Veterans.
Computational models of reward learning (RL), particularly Bayesian RL learning models, can offer an important bridge to link in-vivo behavior, such as social reward sensitivity, and recovery outcomes like psychosocial functioning, by providing a rich quantitative representation of reward learning and its dynamic updating during reward exploration. This proposal aims to capitalize on this approach, combining a translational behavioral paradigm, Bayesian reinforcement learning modeling, and neuroscientific evaluation of change processes, in order to assay social anhedonia and improve prediction of social functioning as well as understanding and effective dissemination of BA treatment.
The specific aims are to: 1) test the effectiveness of BA in improving social functioning outcomes in Veterans (Aim 1); 2) examine the impact of BA on neurocomputational markers of social reward sensitivity and their relationship to social functioning improvement in Veterans (Aim 2); and 3) assess the degree to which neurocomputational markers of social reward sensitivity predict social functioning recovery in Veterans undergoing BA (Aim 3). This project will also explore whether the relationships between neurocomputational markers of social function and clinical outcomes are moderated by primary diagnosis (exploratory Aim 4).
Veterans (N=136) with impaired social functioning and anhedonia will be recruited and randomized to either behavioral activation (BA) or supportive care therapy (SCT; active control) over 12 weeks. At baseline, immediately post-treatment, and 12-weeks post-treatment (24-weeks follow-up), participants will complete a computerized task aimed at probing social reward-seeking behavior, in which they must choose between unknown partners with the goal of maximizing the number of compliments they receive from these partners. Concurrent brain activity will be collected with functional magnetic resonance imaging (fMRI) in a subset of participants (N=68; at baseline and post-treatment). Therapy sessions and follow-up (24-weeks) assessments will be administered through VA-approved telehealth methods. Computational modeling will be used to derive individual parameters of social reward (i.e., compliments) learning and maximization, and to extract associated neural activity, e.g., neural responses to prediction error signals (discrepancies between expected and actually obtained reward/compliment). Randomization of participants to treatment arms will be be stratified based on fMRI eligibility status, sex, and primary psychiatric diagnosis.
This project is expected to 1) determine if BA offers an effective, low-burden option to improve social functioning in Veterans; 2) identify potential neurocognitive targets, which could be used in future research to develop and test novel treatments to improve psychosocial functioning in Veterans, such as computerized neurocomputational training protocols to boost social reward sensitivity; and 3) help identify precise markers of BA responsiveness for functional recovery.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Niloofar Afari, PhD
- Telefonní číslo: (858) 642-3657
- E-mail: Niloofar.Afari@va.gov
Studijní místa
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California
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San Diego, California, Spojené státy, 92161-0002
- VA San Diego Healthcare System, San Diego, CA
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Kontakt:
- Niloofar Afari, PhD
- Telefonní číslo: 858-642-3657
- E-mail: Niloofar.Afari@va.gov
-
Vrchní vyšetřovatel:
- Katia Harle, MD
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- being a Veteran
- having moderate to high levels of social disconnection (Social Connectedness Scale-Revised/SCS-R score < 90)
- having moderate to high levels of social functioning impairments (Sheehan Disability Scale/SDS-social domain score >=5)
- having moderate to high levels of social anhedonia (Specific Loss of Interest and Pleasure Scale/SLIPS score >= 6)
Exclusion Criteria:
- lifetime history of psychotic or bipolar disorder
- neurological conditions, neurodevelopmental disorders, or sensory deficits that may impact cognitive functioning to preclude understanding/completion of study procedure
- regular use of certain psychotropic medications that may significantly impact goal-directed performance on the task (i.e., benzodiazepines, sedative hypnotics, and opioid analgesics); pre-existing stable doses of psychotropic medications, such as SSRIs, will be allowed (if same regimen has been taken for at least 30 days)
- current severe alcohol or substance use disorders (AUD/SUD) necessitating prioritization of substance use treatment
- suicidal or homicidal ideation within the past month necessitating urgent higher-level care
- concurrent individual cognitive-behavioral psychotherapy specifically targeting depression, anhedonia, and/or PTSD
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Behavioral Activation (BA)
This arm provides the experimental treatment, i.e., Behavioral Activation therapy.
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BA is a structured behavioral protocol for depression, designed to help individuals increase engagement in meaningful and rewarding activities, thereby breaking the cycle of avoidance and inactivity that often accompanies depression.
The protocol teaches patients to increase a) engagement in pleasant, reinforcing activities, with a strong emphasis on social engagement and social connection, b) exploration of values, and c) goal-setting and goal-directed behavior, while monitoring their mood and daily activities
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Aktivní komparátor: Supportive Care Therapy (SCT)
This arm provides the active control treatment, i.e., Supportive Care Therapy.
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SCT is a Rogerian non-directive approach and employs techniques to convey a deep understanding of emotions, thoughts, and behaviors of the Veterans receiving this treatment.
Specific techniques include content-focused paraphrasing, exploration through open-ended questions (with a goal of empathic understanding), and emotion-focused reflection and validation.
Consistent with the SCT model, the therapist will be explicitly instructed not to provide advice, assign activities, or suggest strategies and techniques employed in the BA intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Social Connectedness Scale - Revised (SCS-R)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Measures the degree to which individuals feel connected to others in their social environment.
Scores range from 20 to 120, where higher scores indicate a stronger, healthier sense of social connectedness.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Inventory of Psychosocial Functioning (IPF)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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The scale measures the degree of impairment in ability to interact effectively with others, fulfill social roles (e.g., work), and meet personal and societal expectations.
It is comprised of 7 subscales.
Each item ranges from 0 to 6. Higher scores indicate greater degree of impairment in psychosocial functioning.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Specific Loss of Interest and Pleasure Scale (SLIPS)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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This is a measure of social anhedonia, i.e., hypo-responsiveness to social rewards, such as positive human interactions.
Scores range from 0 to 69.
Higher scores indicate greater severity of social anhedonia.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Social Reward Maximization
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Computational parameter derived from behavioral social functioning probe (behavioral reinforcement learning task), capturing the degree to which individuals select social partners they predict to be more rewarding (to offer the most compliments).
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Neural Activation to Social Reward Prediction Errors (RPEs)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Average BOLD (Blood-Oxygenation-Level Dependent) % signal change (i.e., activation) associated with individuals' model-based RPE (difference between expected probability of reward/compliment and actual outcome received.
i.e., compliment vs no-compliment).
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Primary Psychiatric Diagnosis
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Primary diagnostic category (i.e., depressive vs traumatic stress/anxiety disorder)
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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World Health Organization Quality of Life Scale (WHOQOL-BREF)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Measures quality of life and life satisfaction.
Includes 4 domain subscales: physical health (range 7-35), psychological health (range 6-30), social relationships (range 3-15), and environment (range 8-42).
Higher scores indicate higher quality of life.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Patient Health Questionnaire-9 (PHQ-9)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Measures depression severity.
Scores range from 0 to 27.
Higher scores indicate greater depression severity.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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PTSD Checklist-5 (PCL-5)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Measures post-traumatic stress disorder (PTSD) severity.
Scores range from 0 to 80, with higher scores indicating greater PTSD severity.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Beck Anxiety Inventory (BAI)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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This scale measures anxiety severity.
Scores range from 0 to 63, with higher scores indicating greater anxiety severity.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Snaith-Hamilton Pleasure Scale (SHAPS)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Measure of anhedonia.
Score range from 14 to 56, with higher scores indicating greater anhedonia severity.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Reaction to Treatment Questionnaire
Časové okno: Baseline, Post-Treatment (12-weeks)
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Measure of treatment satisfaction and credibility of treatment rationale.
Total scores range from 3 to 27, with higher scores indicating greater satisfaction and credibility in the treatment.
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Baseline, Post-Treatment (12-weeks)
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Mood and Anxiety Symptoms Questionnaire (MASQ-D30)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Measure of anhedonic depression, anxiety, and stress symptoms.
The scale has three subscales (general distress, anhedonic depression, and anxious arousal) , with each score ranging from 10 to 50.
Higher scores indicate greater severity of symptoms.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Liebowitz Social Anxiety Scale (LSAS)
Časové okno: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Assesses the impact of social anxiety on multiple aspects of life.
Scores range from 0 to 144, with higher scores indicating greater social anxiety.
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Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Katia Harle, MD, VA San Diego Healthcare System, San Diego, CA
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RRD4-009-25W
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study as well as statistical code, and therefore these will be sufficient to reproduce or verify any published findings.
Any HIPAA identifiers, or combinations of variables that could be used for re-identification, will be excluded, as will any proprietary information. The plan does not include any access to individually identifiable or proprietary data. Therefore, this plan will ensure the protection of personal privacy, the confidentiality of individually identifiable private information, and the security of proprietary data and information.
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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