Clinical Trial: Enhancement of Treatment of Delusions in Schizophrenia Through Neuromodulation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Enhancement of Treatment of Delusions in Schizophrenia Through Neuromodulation

Brief Summary: The proposed study aims to use a form of neuromodulation, known as transcranial alternating current stimulation (tACS), to improve the effectiveness of the metacognitive training (MCT) program for treatment of delusions in schizophrenia. tACS is a non-invasive brain stimulation method utilizing weak electrical currents applied to the head to influence neural firing (Antal & Paulus, 2013). Brain regions implicated in delusional thinking will be targeted in the hopes of promoting thinking patterns that will allow participants to question delusional beliefs, reducing the severity of delusions and increasing the positive effects of MCT (Whitman et al., in press; Whitman, Minz & Woodward, 2013). Electroencephalogram (EEG) and behavioural assessments will be used to measure treatment effects.

Detailed Summary:

Purpose:

The objective of this study is to enhance a form of nonpharmacological treatment of delusions in schizophrenia using neuromodulation, and confirm the effect using electroencephalogram (EEG) and behavioural measures (Whitman et al., in press; Whitman, Minz & Woodward, 2013). Specifically, transcranial alternating current stimulation (tACS) will be used to improve the outcome of participation in metacognitive training (MCT) for the treatment of psychosis.

MCT is a group-based program developed directly from current cognitive neuropsychiatry research findings on schizophrenia and psychosis. MCT shares knowledge gained in research labs to help individuals experiencing psychosis become more aware of the thinking patterns involved in their illness. The main purpose of the metacognitive training is to help people change the thinking patterns that cause delusions, thereby avoiding relapse into illness or reducing the impact of delusions (Moritz et al., 2014).

tACS is a non-invasive brain stimulation technique in which a weak electrical current is applied to the head in order to change the likelihood of neural firing in a region of cortex under the stimulation electrodes (Antal & Paulus, 2013).

Hypothesis:

Neuromodulation will enhance the benefit of the non-pharmacological treatment program, MCT, in the reduction of severity of delusions in schizophrenia.

Justification:

It is now clear that helping individuals with schizophrenia become aware of the thinking patterns that underlie delusions provides effective tools for countering these thinking patterns (Moritz et al., 2
Sponsor: University of British Columbia

Current Primary Outcome: Psychotic Symptom Rating Scale [ Time Frame: 8 weeks post-treatment ]

Delusion severity will be measured using the Delusions Scale of the Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999). The PSYRATS Delusion Scale measures specific aspects of delusions such as conviction and impact on thinking.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Scale for the Assessment of Negative Symptoms [ Time Frame: 8 weeks post-treatment ]
    General psychopathology will be assessed using the Scale for the Assessment of Negative Symptoms (SANS; Andreasen, 1984).
  • Scale for the Assessment of Positive Symptoms [ Time Frame: 8 weeks post-treatment ]
    General psychopathology will be assessed using the Scale for the Assessment of Positive Symptoms (SAPS; Andreasen, 1984).
  • Signs and Symptoms of Psychotic Illness [ Time Frame: 8 weeks post-treatment ]
    General psychopathology will be assessed using the Signs and Symptoms of Psychotic Illness (SSPI; Liddle et al., 2002).
  • Jumping to Conclusions Task [ Time Frame: 8 weeks post-treatment ]
    A cognitive biases commonly associated with delusions in schizophrenia will be evaluated using the "jumping to conclusions (JTC) task" (also known as the "fish task"). This task will be carried out on computer tablets. These tasks were developed, in part, by the principal investigator and have been described in previous research (Lecomte & Woodward 2005; Woodward 2006a; Woodward 2006b; Woodward 2007; Moritz & Woodward 2005; Woodward 2009).
  • Bias Against Disconfirmatory Evidence Task [ Time Frame: 8 weeks post-treatment ]
    A cognitive biases commonly associated with delusions in schizophrenia will be evaluated using the "bias against disconfirmatory evidence (BADE) task". This task will be carried out on computer tablets. These tasks were developed, in part, by the principal investigator and have been described in previous research (Lecomte & Woodward 2005; Woodward 2006a; Woodward 2006b; Woodward 2007; Moritz & Woodward 2005; Woodward 2009).
  • Electroencephalography Reasoning Bias (Evidence Matching Tasks) [ Time Frame: 8 weeks post-treatment ]
    Subjects will be assessed using electroencephalography (EEG) while they complete tasks in which they must determine whether two pieces of information match, in order to quantify the reactivity of the neural networks believed to be responsible for evidence matching (e.g., anterior-cingulate-based network) and integration of disconfirmatory evidence (bilateral prefrontal-based network). These cognitive bias tasks are the "jumping to conclusions task" (or "fish task") and the "bias against disconfirmatory evidence task" previously described, and were developed in part by the principal investigator.


Original Secondary Outcome: Same as current

Information By: University of British Columbia

Dates:
Date Received: September 28, 2016
Date Started: May 1, 2017
Date Completion: October 2018
Last Updated: March 30, 2017
Last Verified: March 2017