Mobile CBT for Negative Symptoms (mCBTn)

University of California San Diego

Status: Completed

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: Supportive Contact; Behavioral: Mobile-assisted CBT-informed Skills Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03621774

R33MH110019

Details and patient eligibility

About

This randomized controlled clinical trial will test a combined group contact plus mobile CBT-informed skills training intervention targeting defeatist attitudes in consumers with schizophrenia in comparison to a supportive contact control group in order to change motivational negative symptoms linked to defeatist attitudes.

Full description

The primary purpose of this project is to determine if mCBTn at the optimal dose from the R61 produces greater reduction in severity of defeatist attitudes than a supportive contact control group in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms. A second aim is to determine whether reduction in defeatist attitudes mediates improvement in experiential negative symptoms and psychosocial functioning in mCBTn. The third aim is to determine whether mCBTn increases pupil dilation and whether changes in pupil dilation (an objective psychophysiological biomarker of effort) are associated with changes in defeatist attitudes and negative symptoms. The final aim is to explore predictors of response to mCBTn, including device use and group session adherence, demographics, neurocognitive impairment, and negative and other symptom severity at baseline.

Enrollment: 112 patients

Sex: All

Ages: 18 to 60 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.
• 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 skills training (e.g., hospitalized; severe medical illness).
• Unable to adequately see or manually manipulate the mobile device.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups, including a placebo group

Mobile-assisted CBT-informed Skills Training

Experimental group

Description:

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

Treatment:

Behavioral: Mobile-assisted CBT-informed Skills Training

Supportive Contact

Placebo Comparator group

Description:

An active group leader- and device-contact control group.

Treatment:

Behavioral: Supportive Contact