Trial · Interventional
RecruitingNot applicableRegistry dataShort name OXYMIND2
Germany
1 trial · 1 ongoing
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The effectiveness of current treatment options for sociocognitive deficits and negative symptoms (NS) in schizophrenia spectrum disorders (SSD) remains limited. The cause of NS is thought to be an interference between the mesocorticolimbic dopamine system for social reward expectancy and the network for socioemotional processes. Oxytocin (OXT) may enhance functional connectivity between these neuronal networks. Lower plasma OXT levels correlate negatively with NS severity and deficits in social cognition in SSD. It has been shown that intranasal OXT administration improves social cognition in healthy subjects but in SSD results are inconsistent. According to the social salience hypothesis, the effect of OXT varies depending on the social context and individual factors. Also, OXT-mediated effects on psychopathology and NS may depend on genetic variants of OXT receptors (OXTR). In a pilot study, the investigators demonstrated lower NS by OXT administration in a positive social context of mindfulness-based group psychotherapy (MBGT) in SSD. The investigators also demonstrated that symptoms improved after MBGT. A more recent study suggests that, compared to placebo, administering OXT in a positive social context via MBGT leads to significant between-group differences favoring OXT, particularly in NS, affect, and stress. Building on these findings, the present study investigates the stability of these effects, along with psychological and biological markers, in a larger sample of individuals with SSD. The main hypothesis to be tested is that the use of OXT compared to placebo prior to MBGT in patients with SSD will result in a greater reduction in NS with a higher OXT dosage. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.
Active comparator
Oxytocin (24 I.U. Syntocinon®)
The patients received a spray of synthetic oxytocin (24 I.U. Syntocinon®) in combination with mindfulness-based group therapy (MBGT) over 4 weeks once a week. Due to an effect latency of 30-80 min after intranasal administration of oxytocin on social behavior, the dose was administered 30 min before the 50 min session.
Active comparator
Oxytocin (48 I.U. Syntocinon®)
The patients received a spray of synthetic oxytocin (48 I.U. Syntocinon®) in combination with mindfulness-based group therapy (MBGT) over 4 weeks once a week. Due to an effect latency of 30-80 min after intranasal administration of oxytocin on social behavior, the dose was administered 30 min before the 50 min session.
Placebo comparator
Placebo
The patients received a placebo nasal spray in combination with mindfulness-based group therapy (MBGT) over 4 weeks once a week. The dose was administered 30 min before the 50 min session for blinding reasons.
Outcomes the sponsor listed as primary.
Change in BNSS Brief Negative Symptom Scale
Time frame · Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
The Brief Negative Symptom Scale (BNSS) is a 13-item rater-based instrument designed for clinical trials and other studies that measures 5 domains: blunted affect, alogia, asociality, anhedonia, and avolition. The interrater, test-retest, and internal consistency of the instrument were strong, with respective intraclass correlation coefficients of 0.93 for the BNSS total score and values of 0.89-0.95 for individual subscales. The minimal score is 0 and the maximal score is 78. Higher scores indicate a worse outcome.
Change and group differences in PANSS Positive and Negative Syndrome Scale
Time frame · Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
The Positive and Negative Syndrome Scale (PANSS) is one of the most widely used rater instruments for the assessment of the presence and severity of psychotic symptoms. Each scale comprises seven statements which are rated by the interviewer using a seven-point Likert format (from 1= absent to 7= extreme). The minimal score is 30 and the maximal score is 210. Higher scores indicate a worse outcome. The PANSS is reported to have satisfactory internal consistency, good interrater reliability and construct validity.
Change and group differences in SNS Self-Evaluation of Negative Symptoms
Time frame · Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
The Self-Evaluation of Negative Symptoms (SNS) is a 20-item self-reported questionnaire with five subscales, namely alogia, avolition, anhedonia, social withdrawal and diminished emotional range. These subscales cluster on two factors, the apathy and emotional components. Participants can estimate the answer to each question on a scale from 0 (strongly disagree) to 2 (strongly agree). The minimal score is 0 and the maximal score is 40. Higher scores indicate a worse outcome. The scale was shown to have good internal consistency with Cronbach's alpha = .87.
Change and group differences in CDSS Calgary Depression Scale of Schizophrenia
Time frame · Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
The Calgary Depression Scale for Schizophrenia (CDSS) is a nine item clinician rated outcome measure that assesses the level of depression in people with schizophrenia. It is the only depression scale designed to assess depression in people with a schizophrenia spectrum disorder. It distinguishes depressive symptoms from negative symptoms and is sensitive to change. The minimal score is 0 and the maximal score is 27. Higher scores indicate a worse outcome.
Change and group differences in PSS Perceived Stress Scale
Time frame · Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
The Perceived Stress Scale (PSS) is a well-established, reliable, and valid 10-item self-report scale that measures perceived stress on a 5-point response scale (0 = "never", 1 = "almost never", 2 = "sometimes", 3 = "fairly often", 4 = "very often"). The German version of the PSS has demonstrated good internal consistency (Cronbach's α = 0.84). The minimal score is 10 and the maximal score is 50. Higher scores indicate a worse outcome.
Change and group differences in SMQ Southampton Mindfulness Questionnaire
Time frame · Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)
The Southampton Mindfulness Questionnaire (SMQ) comprises 16 items that are rated on a seven-point Likert-scale ranging from (6) "agree totally" to (0) "disagree totally". Consequently, the total score ranges from 0 to 96, with a higher score indicating higher mindfulness. The internal consistency of the German version of the SMQ was Cronbach's α = 0.89.
Change and group differences in PANAS Positive and Negative Affect Scale
Time frame · Pre- and post-intervention in week 1-4 (T0-T7)
The Positive and Negative Affect Scale (PANAS) contains 20 items, each consisting of an adjective describing an emotion. The participants have to select how applicable this adjective is to their current state from 1 (not at all) to 5 (extremely). The minimal score is 20 and the maximal score is 100. Higher scores indicate a worse outcome. Ten items are assigned to the positive (e.g. "Excited") as well as the negative scale (e.g. "Fearful"). The reliability of the PANAS ranges from .86 to .93.
Change and group differences in stress via visual analogue scale (Bubbles)
Time frame · Pre- and post-intervention in week 1-4 (T0-T7)
Stress via visual analogue scale. Self-rating instrument to measure stress through four items on a seven-point Likert-scale ranging from "not at all" (0) to "extreme" (6) visualized through bubbles increasing in size. The minimal score is 0 and the maximal score is 24. Higher scores indicate a worse outcome.
Change and group differences in GCQ-S Group Climate Questionnaire (Short Version)
Time frame · Post-intervention in week 1-4 (T1, T3, T5, T7)
The Group Climate Questionnaire \[Short Version\] (GCQ-S) is a 12 item questionnaire designed to assess individual group members' perceptions of the group's therapeutic environment. It consists of three domains: Engaged, conflict and avoiding and will be used as a self-report, such as a rater-based instrument. The minimal score is 0 and the maximal score is 72. Higher scores indicate a worse outcome.
Change and group differences in PSP Personal and Social Performance scale
Time frame · Baseline rating (T0) and post-intervention rating at week 4 (T8)
The Personal and Social Performance Scale (PSP) is a rater-based questionnaire used to assess social functioning in patients with SSD. The minimal score is 1 and the maximal score is 100. Higher scores indicate a better outcome. The PSP showed good test-retest reliability (ICC = 0.79) in patients with schizophrenia.
Change and group differences in endocannabinoid levels
Time frame · Pre- and post-intervention in week 1 (T0, T1), post-intervention in week 4 (T7) and follow-up 1 (week 8, T9)
Venous blood samples will be taken to determine the endocannabinoid levels to obtain an individual baseline and comparison level.
Change and group differences in interleukin levels
Time frame · Pre-intervention in week 1 (T0) and post-intervention in week 4 (T7)
Venous blood samples will be taken to determine the interleukin levels to obtain an individual baseline and comparison level.
Change and group differences in oxytocin levels
Time frame · Pre- and post-intervention in week 1 (T0, T1) and post-intervention in week 4 (T7)
Venous blood samples will be taken to determine the oxytocin levels to obtain an individual baseline and comparison level.
Change and group differences in PBMC levels
Time frame · Pre-intervention in week 1 (T0) and post-intervention in week 4 (T7)
Venous blood samples will be taken to determine the PBMC levels to obtain an individual baseline and comparison level.
Change and group differences in cortisol saliva levels
Time frame · Pre- and post-intervention in week 1-4 (T0-T7)
Saliva samples will be taken before and after each MBGT session to determine Cortisol saliva levels
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Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2024
Zierhut et al. 2024Journal of psychiatric researchcited by 16
PMID 38309212DOI 10.1016/j.jpsychires.2024.01.014PUB-38309212
1 study on this page
PubMed tag: none · 2024
Böge et al. 2024International journal of clinical and health psychology : IJCHPcited by 7
PMID 39308779PMC11415965DOI 10.1016/j.ijchp.2024.100503PUB-39308779
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