Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia (mCBTn)

Eric Granholm

Status: Completed

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: Mobile-assisted CBT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03179696

1R61MH110019-01 (U.S. NIH Grant/Contract)

R61MH110019

Details and patient eligibility

About

This clinical trial will test a combined group therapy plus mobile cognitive behavioral therapy intervention targeting defeatist attitudes in consumers with schizophrenia in order to change motivational negative symptoms linked to defeatist attitudes.

Full description

The primary purpose of this project is to test whether a psychosocial intervention, Cognitive Behavioral Social Skills Training (CBSST) combined with a smartphone-based cognitive-behavioral therapy for negative symptoms called, Mobile-assisted Cognitive Behavioral Therapy for Negative Symptoms (mCBTn) can reduce defeatist performance attitudes in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms.The project will also identify the optimal dose to engage the defeatist attitude target. Pupillary responses, an objective psychophysiological biomarker of effort, will be recorded during a cognitive task as a secondary outcome to determine its potential as an end point in clinical trials of motivation and effort.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• DSM-5 diagnosis of schizophrenia or schizoaffective disorder.
• Meets prospective criteria for persistent moderate-to-severe experiential negative symptoms in at least two of the three CAINS Motivation and Pleasure domains (mean of 2 -moderate- or greater for items averaged within the Social, Work or Recreational domains) at the beginning and end of a 2-week evaluation phase.
• Moderate-to-severe defeatist attitudes (DPAS > 50).
• ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual consumer workbook).
• Clinically stable and stable on current medications (no changes within 3 months prior to enrollment and meeting all inclusion/exclusion criteria during longitudinal baseline evaluation at both week -2 and 0).

Exclusion criteria

• Prior CBT in the past 2 years.
• Greater than moderate PANSS positive symptoms (P1-Delusions, P2- Disorganization, P3-Hallucinations, or P6-Suspiciousness - any item >5).
• Severe depression on the Calgary Depression Scale for Schizophrenia (CDS >8).
• Extrapyramidal symptoms (Simpson-Angus Scale >7).
• Ocular damage, disease, surgery or medications that affect pupil dilation.
• DSM-5 alcohol or substance use disorder in past 3 months.
• Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness).
• Unable to adequately see or manually manipulate the mobile device.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 1 patient group

Mobile-assisted CBT

Experimental group

Description:

Psychosocial intervention combining in-person and smartphone-based cognitive-behavioral therapy (CBT) for experiential negative symptoms in schizophrenia called, Mobile-assisted Cognitive-Behavioral Therapy for Negative symptoms (mCBTn).

Treatment:

Behavioral: Mobile-assisted CBT