Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, San Diego
About this trial
This randomized clinical trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary informed consent to participate and capacity to consent; Age 18 to 65;
Diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a diagnostic interview and available medical record review;
Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;
Be willing and able to speak English at ≥ 6th grade reading level (to read intervention workbook).
Disqualifiers
Prior cognitive-behavioral therapy in the past 2 years;
Greater than moderate disorganization on the PANSS (P2- Disorganization item >5);
Alcohol or substance dependence in past 3 months based on the diagnostic interview;
Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness);
Trial design
Design model
Parallel
Treatments tested in this trial
Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)
BehavioralmSITE is a blended intervention that integrates a brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching. Participants will attend weekly, in-person sessions for 8 weeks and then 15-minute, remote coaching sessions for 10 weeks. The intervention begins with setting a meaningful recovery goal and then the generic cognitive model is introduced and a simple thought challenging skill is trained to specifically address social avoidance behaviors and facilitate work toward recovery goals. Defeatist attitudes, social threat and avoidance behaviors that interfere with working on the goal are then modified using cognitive-behavioral therapy skills and practiced using role-plays.
Supportive Contact (SC)
BehavioralThe SC arm will match the mSITE arm on the same amount of individual in-person and coaching, and mobile device contact. Coaching sessions will be semi-structured and consist of setting recovery goals, check-in about symptoms and potential crisis management, flexible discussion involving psychoeducation, instructions for accessing community crisis lines and community resources, and symptom management behaviors that grow out of discussions, with only minimal therapist guidance.
Treatment groups
125 Participants
are divided into 2 treatment groupsGroup A: mobile Social Interaction Therapy by Exposure (mSITE)Experimental treatment 1 intervention
Group B: Supportive Contact (SC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ecological Momentary Assessment
Ecological Momentary Assessment (EMA) is a method of remote data collection that involves repeatedly sampling a participant's current behaviors, thoughts, mood, and experiences in real time, in their natural environments. The primary outcome in this study will be the number of social interactions.
Time frame
Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.2
Clinical Assessment Interview for Negative Symptoms
Measure changes in motivational negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS). The CAINS is a 13-item interview-based assessment of negative symptoms, and each item is rated from 0 (no impairment) to 4 (severe deficit) measuring the two negative symptom factors recommended in consensus reports: Expression and Motivation and Pleasure (MAP) across social, vocational and recreational domains. Total scores for each factor are computed. The range for the MAP is 0 - 36, and the range for the Expression factor is 0 - 16. Higher scores indicate more severe negative symptoms for both factors.
Time frame
Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.3
Birchwood Social Functioning Scale
Measure changes in functioning on the Birchwood Social Functioning Scale (SFS). The SFS is a self-report assessment of functioning with 7 subscales, and each item is rated from 0 to 3 with the exception of the Occupation/Employment subscale if a participant is in regular employment (scores range from 7-10 based upon type of work). The subscales and score ranges are: Social Engagement Withdrawal (0-15), Interpersonal Communication/Relationships (0-30), Prosocial Activities (0-66), Recreation (0-48), Independence-Performance (0-39), Independence-Competence (0-39), and Occupation/Employment (0-10). Higher scores indicate better functioning for all subscales.
Time frame
Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.4
Positive And Negative Syndrome Scale
The Positive And Negative Syndrome Scale (PANSS) is a 30-item interview that provides balanced representation of positive and negative symptoms and gauges their relationship to one another and to global psychopathology. Items are rated 1 (Absent) to 7 (Extreme) and summed across items for a total range of scores of 30-210. Higher scores indicate the presence of more severe symptoms.
Time frame
Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov