Table 1.
Characteristics of Included Studies and the Percentage of AE Thematic Codes Identified From the Content Analysis
| Author, Year, Country | Name of DHI | Type of DHI | DHI Content | Sample Size | No. AEs Reported and Details If Serious | Sample Recruited | Relatedness | Typology | Percentage of Thematic Codes Identified During Content Analysis |
|---|---|---|---|---|---|---|---|---|---|
| Alvarez-Jimenez et al., 2021, Australia26 | HORYZONS | Online forum | Website | 170 | 45 SAEs | FEP | No related AEs reported (n = 45) | Intended targets: Patients where used: Used at home Facilitator involvement: Asynchronous human feedback Intervention interactions: Peer Contac, Treatment target: Relapse prevention, social functioning, vocational recovery Platform: Website |
Psychosis exacerbation: 25.6% Psychiatric admission: 34.1% Suicide ideation: 7.3% Affective exacerbation: 9.8% Physical health admission: 22% |
| Berry et al., 2021, UK27 | Assessing measures of physical activity and sleep in schizophrenia | Sleep and physical activity monitoring and feedback via wearables | Wearables | 30 | 12, all AEs | Schizophrenia spectrum disorders | Relatedness not reported (n = 12) | Intended targets: Patients Facilitator involvement: None Where used: Used at home Treatment targets: None (exploring acceptability of self-monitoring) Platform: Mobile Phone app, wearable |
Affective exacerbation: 50% Psychosis exacerbation: 50% |
| Bonet et al., 2020, Spain28 | Remindcare app | Smartphone app | Self-monitoring; Medication reminders | 59 | 25, Of which 12 were AEs and 13 were serious AEs | FEP | Related to intervention (n = 2—AEs), related to trial procedures (n = 1—SAE), unrelated (n = 13) Relatedness not reported (n = 9—all AEs) |
Intended targets: Patients Facilitator involvement: Asynchronous human contact (mental health staff responded to data indicating clinical change, patients requesting support or discontinuation alerts for patients not using the app) Where used: Home and with Clinicians Intervention interactions: Self-monitoring Treatment targets: Self-management, symptom monitoring Platform: Mobile app |
Harm to others: 2.1% Suicide ideation: 2.1% Suicide plan: 2.1% Self-harm: 2.1% Stopping medication: 4.2% Psychiatric admission: 6.2% Crisis care nonadmission: 12.5% Psychosis exacerbation: 39.6% Increased standard mental health care: 29.2% |
| Bucci et al (in preparation), UK | Actissist app; ClinTouch app | Smartphone apps | Actissist: CBT strategies targeting early psychosis relapse indicators. ClinTouch: psychotic and mood symptoms monitoring |
172 | 95, of which n = 67 AEs, n = 19 serious adverse event, n = 10 adverse reaction | FEP (within 5 years of first onset) | 0 serious events were related to the study hardware, software, or study assessments. 9 nonserious AEs: Related to software (n = 3), related to hardware (n = 2), related to study assessments (n = 4) |
Intended targets: Patients Facilitator involvement: None Where used: Home Intervention interactions: Self-monitoring; Software-based feedback Treatment targets: Self-management Platform: Mobile app |
Harm to others: 1.2% Encounters with legal system: 3.1% Other: 3.1% Psychosis exacerbation: 8.6% Psychiatric admission: 6.8% Affective exacerbation: 12.3% Self-harm—9.3% Substance Misuse—6.8% crisis care nonadmission—5.6% Physical health admission: 4.3% Physical health treatment: 14.2% Suicide ideation: 11.1% Suicide plan: 3.7% Increased standard mental health care: 9.3% |
| Bucci et al., 2018, UK29 | Actissist app; ClinTouch app | Smartphone apps | Actissist: CBT strategies targeting early psychosis relapse indicators. ClinTouch: psychotic and mood symptoms monitoring |
36 | 6, of which 4 SAEs and 2 AEs | FEP (within 5 years of first onset) | No related AEs reported (n = 6) | Intended targets: Patients Facilitator involvement: None Where used: Home Intervention interactions: Self-monitoring; Software-based feedback Treatment targets: Self-management Platform: Mobile app |
Crisis care nonadmission: 20% Increased standard mental health care: 10% Harm to others: 10% Psychiatric admission: 10% Psychosis exacerbation: 20% Self-harm: 20% Stopping medication: 10% |
| Cella et al., 2022, UK30 | V-NeST: a pilot randomized control trial | VR supported therapy | VR supported therapy (12 sessions) | 30 | 13, of which 11 AEs and 2 SAEs | Schizophrenia spectrum disorders | No related AEs reported | Intended targets: Patients Where used: Used with clinician Facilitator involvement: Synchronous human contact (therapist) Intervention interactions: Therapy Treatment targets: Negative symptoms Platform: VR |
Affective exacerbation: 50% Stopping medication: 25% Suicide ideation: 25% |
| Depp et al., 2019, USA31 | CBT2Go | Smartphone app | EMA; CBT strategies | 255 | 33—unclear from reporting whether considered AE or SAE | Schizophrenia; Bipolar disorder | Relatedness not reported (n = 33). | Intended targets: Patients Facilitator involvement: Synchronous human contact (one-off therapy session, weekly phone calls Where used: Home and with clinician Treatment targets: Self-Management, Defeatist beliefs Platform: Mobile phone app |
Psychosis admission: 38.5% Psychosis exacerbation: 38.5% Physical health treatment: 9.6% Physical health admission: 13.5% |
| Eisner et al., 2019, UK32 | ExPRESS | Smartphone app | Symptoms monitoring | 18 | 3, all AEs | Schizophrenia spectrum disorders | No related AEs reported (n = 3) | Intended targets: Patients Facilitator involvement: Synchronous human contact (phone calls) Where used: Home Intervention interactions: Self-monitoring; Software-based feedback Treatment targets: Symptom monitoring Platform: Mobile phone app |
Psychosis exacerbation: 100% |
| Garety et al., 2021, UK22 | SlowMo | Smartphone app blended with 8 sessions of CBT | Self-monitoring; Active psychoeducation | 361 | 51, of n = 1 adverse reaction, AE n = 1, n = 1 serious adverse reaction, n = 48 SAEs | Schizophrenia spectrum disorders | Related to hardware (n = 1—adverse reaction), related to trial procedures (n = 1), not related (n-47), relatedness uncertain (n = 1) | Intended targets: Patients Where used: Used with clinician and at home Facilitator involvement: Synchronous human contact (therapist) Intervention interactions: Self-monitoring; Software-based feedback; Therapy Treatment targets: Paranoia Platform: Mobile phone app |
Affective exacerbation: 6.1% crisis care (nonadmission): 5.3% Encounters with legal systems: 7.6% Harm to others: 3.8% Harm from others: 3.8% Increased standard mental health care: 10.6% Other: 1.5% Physical health treatment: 3.8% Physical health admission: 5.3% Psychosis exacerbation: 12.1% Psychiatric admission: 14.4% Stopping medication: 5.3% Self-harm: 2.3% Substance misuse: 9.8% Suicide ideation: 6.1% Suicide plan: 0.8% Increased standard mental health care: 10.6% |
| Granholm et al, 2020, USA33 | MA-CBSST | PDA EMI programme | Homework reminders; Behavioral activation | 57 | 3, of which 2 SAEs and 1 AE | Older adults schizophrenia/schizoaffective disorder | No related AEs reported (n = 3) | Intended targets: Patients Facilitator involvement: Synchronous human contact (therapist) Where used: Home Intervention interactions: Peer contact (group therapy), Group therapy, prompting Treatment targets: Social skills Platform: PDA |
Psychosis exacerbation: 25% Psychiatric hospital admission: 12% Physical health admission: 12% Stopping medication: 25% Suicide ideation: 25% |
| Granholm et al., 2020, USA34 | mCBTn | App blended with 12 sessions of group therapy | Mobile App | 31 | 1 SAE | Schizophrenia spectrum disorders | No related AEs reported (n = 1) | Intended targets: Patients Where used: Used with clinician and used at home Facilitator involvement: Synchronous human contact (therapist) Intervention interactions: Peer contact; Self-monitoring; Synchronous human feedback (therapy) Treatment targets: Negative symptoms Platform: Mobile phone app |
Physical health admission: 33% Psychosis exacerbation: 33% Suicide ideation: 33% |
| Gumley et al., 2022, UK and Australia35 | EMPOWER | Smartphone app blended with peer support phone calls | Active symptom monitoring | 73 | 11, of which 10 AEs and 1 SAE | Schizophrenia spectrum disorders | Related to intervention software (n = 10), related to hardware (n = 1) | Intended targets: Patients, carers, and mental health staff Facilitator involvement: Synchronous human contact (peer support worker phone calls) Where used: Home and during routine mental health encounters. Intervention interactions: Self-monitoring; Peer support contact; Software-based feedback Treatment targets: Self-management, relapse prevention. Platform: Mobile phone app |
Affective exacerbation: 64.3% Physical health admission: 7.1% Psychosis exacerbation: 14.3 % |
| Homan et al., 2020, USA36 | ICRC program; 4 interventions | Individually tailored combination of: smartphone app, daily support website, online CBT modules, prescriber decision support system algorithm | Self-monitoring on an app; Website; Computer program | 462 | 274 SAEs | Schizophrenia spectrum conditions | Relatedness not reported (n = 274, all serious AEs). | Intended targets: Patients and mental health staff Where used: Used at home and with clinicians Facilitator involvement: Synchronous human contact (therapist), asynchronous peer contact (forum) Intervention interactions: Therapy, software-based feedback, self-monitoring Treatment targets: Relapse prevention Platform: Website, Mobile app, Computer program (delivered via website) Staff: Computer program |
Physical health admission: 3.7% Physical health treatment: 2.3% Substance misuse: 6% Suicide ideation: 8.2% Suicide plan: 2.3% Self-harm: 1.4% Suicide attempt: 1.5% Affective exacerbation: 10.5% Psychosis Exacerbation: 23% Increased standard mental health care: 1.6% Crisis care (nonadmission): 1.3% Psychiatric admission: 26.3% Encounters with legal systems: 3.9% Harm to others: 3.2% Harm from others: 0.1% Other: 0.2% |
| Myin-Germeys et al., 2022, Belgium37 | INTERACT | Smartphone app blended with therapy | Acceptance and commitment therapy strategies | 148 | 5 SAEs | Early psychosis | Related to trial procedure (n = 1), unrelated (n = 3) Relatedness not reported for n = 1 AE All were serious AEs (n = 5) |
Intended targets: Patients Where used: Used with clinician and at home Facilitator involvement: Synchronous human contact (therapist) intervention interactions: Self-monitoring; Software-based feedback, therapy Treatment targets: Reducing distress Platform: Mobile phone app |
Affective Exacerbation: 9.1% Death by suicide: 9.1% Psychosis exacerbation: 18.2% Physical health treatment: 9.1% Psychiatric admission: 27.3% Stopping medication: 9.1% Suicide ideation: 9.1% Suicide panning: 9.1% |
| Pot-Kolder et al., 2018, Netherlands38 | VR-based cognitive behavioral therapy for patients with psychotic disorders | VR supported therapy | VR supported therapy (16 sessions) | 116 | 2 SAEs | Psychotic disorders | No related AEs reported (n = 2, serious AEs) | Intended targets: Patients Where used: With clinician Facilitator involvement: Synchronous human contact (therapist) Intervention interactions: Therapy Treatment targets: Paranoia (positive symptoms) and safety behaviors Platform: VR |
Death (not suicide): 100% |
| Rus-Calafell et al, 2014, Spain39 | Social skills training | VR supported therapy | VR supported therapy (16 sessions) | 12 | 11 AEs | Schizophrenia spectrum disorders | No related AEs reported (n = 12) | Intended targets: Patients Where used: With clinician VR; Synchronous human; Feedback (therapy) Treatment target: Social Skills Platform: VR |
Psychosis exacerbation: 100% |
| Thonon et al, 2022, USA40 | A group intervention for motivational deficits: preliminary investigation of a blended care approach using ambulatory assessment | Smartphone app blended + group therapy | ESM supported therapy | 8 | 2 AEs | Schizophrenia spectrum disorders | No related AEs reported (n = 2) | Intended targets: Patients Where used: Used with clinician and at home Intervention interactions: Self-monitoring; Peer contact (during group therapy); Therapy Treatment targets: Social skills Platform: Mobile app, wearable |
Psychiatric admission: 50% Substance misuse: 50% |
| von Malachowsk et al., 2022, Germany41 | IMPACHS | Smartphone app | CBT courses; Self-assessment | 24 | 1 AE | Schizophrenia spectrum disorders | No related AEs reported (n = 1) | Intended targets: Patients and staff Facilitator involvement: Synchronous human contact (therapist) Where used: Home and with clinicians Intervention interactions: Software-based feedback, Self-monitoring; Therapy treatment targets: Self-management, general psychosis symptoms Platform: Mobile app Staff platform: Website |
Psychiatric admission: 100% |
Note: ARs, adverse reactions; CBT, cognitive behavior therapy; EMA, ecological momentary assessment; EMI, ecological momentary intervention; ESM, experience sampling methodology; FEP, first episode psychosis; ICRC, improving care and reducing cost; MA-CBSST, mobile-assisted CBSST intervention; mCBT, mobile-assisted cognitive behavioral therapy for negative symptom; PDA, personal digital assistant; UK, United Kingdom; USA, United States of America; V-NeST, virtual reality supported therapy for the negative symptoms of psychosis; VR, virtual reality.