Mobile CBT for Negative Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mobile-assisted CBT-informed Skills Training

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).

Group Type EXPERIMENTAL

Mobile-assisted CBT-informed Skills Training

Intervention Type BEHAVIORAL

mCBTn combines the CBT-informed components that target defeatist attitudes from Cognitive Behavioral Social Skills Training (CBSST) group skills training and mobile smartphone interventions from our prior clinical trials research.

Supportive Contact

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

Group Type PLACEBO_COMPARATOR

Supportive Contact

Intervention Type BEHAVIORAL

The SC intervention will provide the same amount of group and mobile device contact as the mCBTn condition. Participants will be carrying a phone but will not have access to the CBT-informed app. Group contact sessions will be semi-structured and consist of trouble-shooting device use and check-in about symptoms and potential crisis management, followed by a flexible discussion involving psychoeducation, instructions for accessing community crisis lines and related community resources, empathy, and non-directive reinforcement of health, coping, and symptom management behaviors that grow out of group discussions, with only minimal group leader guidance.

Interventions

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Mobile-assisted CBT-informed Skills Training

mCBTn combines the CBT-informed components that target defeatist attitudes from Cognitive Behavioral Social Skills Training (CBSST) group skills training and mobile smartphone interventions from our prior clinical trials research.

Intervention Type BEHAVIORAL

Supportive Contact

The SC intervention will provide the same amount of group and mobile device contact as the mCBTn condition. Participants will be carrying a phone but will not have access to the CBT-informed app. Group contact sessions will be semi-structured and consist of trouble-shooting device use and check-in about symptoms and potential crisis management, followed by a flexible discussion involving psychoeducation, instructions for accessing community crisis lines and related community resources, empathy, and non-directive reinforcement of health, coping, and symptom management behaviors that grow out of group discussions, with only minimal group leader guidance.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No