SchizophreniamCBTnNCT03179696
Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia
A study testing Mobile-assisted CBT in people with Schizophrenia and Schizoaffective Disorder, run by Eric Granholm.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Mobile-assisted CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2016to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Mobile-assisted CBT
- Keywords
- Schizophrenia, CBSST, mobile CBT, negative symptoms
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-assisted CBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile-assisted CBT | Experimental | 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). Receives: Behavioral: Mobile-assisted CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defeatist performance beliefs (target mechanism)
Measure reduction of defeatist performance beliefs severity using the Defeatist Performance Attitude Scale.
Measured: Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24.
Secondary outcomes (2)
Pupillary responses as effort biomarker
Measure changes in pupil dilation recorded during a digit span task.
Measured: Assess change from baseline in pupil dilation at week 12, 18 and 24.
Clinical Assessment Interview for Negative Symptoms (CAINS)
Measure changes in motivational negative symptoms on the CAINS.
Measured: Assess change from baseline in negative symptoms at week 12, 18 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start15 Aug 2016
- Primary completion19 Jul 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Granholm
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Eric Granholm, University of California, San Diego
- Investigators
- Eric L. Granholm, PhD, Principal investigator, University of California, San Diego; San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179696
- Sponsor's protocol ID
- R61MH110019
- Other IDs
- 1R61MH110019-01
- Acronym
- mCBTn
- Status last verified
- Nov 2024
- First submitted
- 25 May 2017
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. doi: 10.1093/schbul/sbl057. Epub 2006 Nov 10.
PubMed 17099070Rector NA, Beck AT, Stolar N. The negative symptoms of schizophrenia: a cognitive perspective. Can J Psychiatry. 2005 Apr;50(5):247-57. doi: 10.1177/070674370505000503.
PubMed 15968839Granholm E, Ben-Zeev D, Link PC, Bradshaw KR, Holden JL. Mobile Assessment and Treatment for Schizophrenia (MATS): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations. Schizophr Bull. 2012 May;38(3):414-25. doi: 10.1093/schbul/sbr155. Epub 2011 Nov 10.
PubMed 22080492Granholm E, Holden J, Link PC, McQuaid JR. Randomized clinical trial of cognitive behavioral social skills training for schizophrenia: improvement in functioning and experiential negative symptoms. J Consult Clin Psychol. 2014 Dec;82(6):1173-85. doi: 10.1037/a0037098. Epub 2014 Jun 9.
PubMed 24911420Granholm E, Ruiz I, Gallegos-Rodriguez Y, Holden J, Link PC. Pupillary Responses as a Biomarker of Diminished Effort Associated With Defeatist Attitudes and Negative Symptoms in Schizophrenia. Biol Psychiatry. 2016 Oct 15;80(8):581-8. doi: 10.1016/j.biopsych.2015.08.037. Epub 2015 Sep 15.
PubMed 26475673Granholm E, Holden J, Dwyer K, Mikhael T, Link P, Depp C. Mobile-Assisted Cognitive Behavioral Therapy for Negative Symptoms: Open Single-Arm Trial With Schizophrenia Patients. JMIR Ment Health. 2020 Dec 1;7(12):e24406. doi: 10.2196/24406.
PubMed 33258792
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia
- ClinicalTrials.gov ID
- NCT03179696
- Acronym / sponsor ID
- mCBTn / R61MH110019
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, CBSST, mobile CBT, negative symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Eric GranholmUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile-assisted CBT | Experimental | Behavioral: Mobile-assisted CBTPsychosocial 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile-assisted CBTmCBTn 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. | Behavioural | Mobile-assisted CBT |
Primary outcome
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.
2 secondary outcomes
Pupillary responses as effort biomarker
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 17099070Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. doi: 10.1093/schbul/sbl057. Epub 2006 Nov 10.
- Background: PubMed 15968839Rector NA, Beck AT, Stolar N. The negative symptoms of schizophrenia: a cognitive perspective. Can J Psychiatry. 2005 Apr;50(5):247-57. doi: 10.1177/070674370505000503.
- Background: PubMed 22080492Granholm E, Ben-Zeev D, Link PC, Bradshaw KR, Holden JL. Mobile Assessment and Treatment for Schizophrenia (MATS): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations. Schizophr Bull. 2012 May;38(3):414-25. doi: 10.1093/schbul/sbr155. Epub 2011 Nov 10.
- Background: PubMed 24911420Granholm E, Holden J, Link PC, McQuaid JR. Randomized clinical trial of cognitive behavioral social skills training for schizophrenia: improvement in functioning and experiential negative symptoms. J Consult Clin Psychol. 2014 Dec;82(6):1173-85. doi: 10.1037/a0037098. Epub 2014 Jun 9.
- Background: PubMed 26475673Granholm E, Ruiz I, Gallegos-Rodriguez Y, Holden J, Link PC. Pupillary Responses as a Biomarker of Diminished Effort Associated With Defeatist Attitudes and Negative Symptoms in Schizophrenia. Biol Psychiatry. 2016 Oct 15;80(8):581-8. doi: 10.1016/j.biopsych.2015.08.037. Epub 2015 Sep 15.
- Derived from this study: PubMed 33258792Granholm E, Holden J, Dwyer K, Mikhael T, Link P, Depp C. Mobile-Assisted Cognitive Behavioral Therapy for Negative Symptoms: Open Single-Arm Trial With Schizophrenia Patients. JMIR Ment Health. 2020 Dec 1;7(12):e24406. doi: 10.2196/24406.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric L. Granholm, PhD principal investigator
University of California, San Diego; San Diego Veterans Healthcare System
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-assisted CBT in people with Schizophrenia and Schizoaffective Disorder, run by Eric Granholm.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defeatist performance beliefs (target mechanism) (time frame: Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03179696, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.