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

November 6, 2024 updated by: Eric Granholm
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile-assisted CBT
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).
Behavioral: Mobile-assisted CBT
mCBTn combines the CBT components that target defeatist attitudes from Cognitive Behavioral Social Skills Training (CBSST) group therapy and mobile smartphone interventions from our prior clinical trials research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defeatist performance beliefs (target mechanism)
Time Frame: Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24.
Measure reduction of defeatist performance beliefs severity using the Defeatist Performance Attitude Scale.
Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pupillary responses as effort biomarker
Time Frame: Assess change from baseline in pupil dilation at week 12, 18 and 24.
Measure changes in pupil dilation recorded during a digit span task.
Assess change from baseline in pupil dilation at week 12, 18 and 24.
Clinical Assessment Interview for Negative Symptoms (CAINS)
Time Frame: Assess change from baseline in negative symptoms at week 12, 18 and 24.
Measure changes in motivational negative symptoms on the CAINS.
Assess change from baseline in negative symptoms at week 12, 18 and 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eric Granholm

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Eric L. Granholm, PhD, University of California, San Diego; San Diego Veterans Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2016

Primary Completion (Actual)

July 19, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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