Clinical trial NCT03621774: Mobile CBT for Negative Symptoms
Official title: Mobile-assisted Cognitive Behavioral Therapy for Negative Symptoms in Schizophrenia: An RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
CBT
Mobile CBT
Negative Symptoms
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-08-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Defeatist performance beliefs (target mechanism) using the Defeatist Performance Attitude Scale
timeFrame: Assess change from baseline in defeatist performance beliefs at weeks 9, 18, and 42.
measure: Clinical Assessment Interview for Negative Symptoms (CAINS)
timeFrame: Assess change from baseline in negative symptoms at weeks 9, 18, and 42.
Secondary outcomes:
measure: Pupillary responses as effort biomarker
timeFrame: Assess change from baseline in pupil dilation at weeks 9, 18, and 42.
measure: Birchwood Social Functioning Scale (SFS)
timeFrame: Assess change from baseline in functioning at weeks 9, 18, and 42.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: UC San Diego
name: Eric Granholm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rector 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.
citation: Granholm 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.
citation: Granholm 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.
citation: Granholm 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.