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Table 1 Overview of the evidence of the permanently included DiHA; 09/2020 – 02/2022 (based on information of DiHA directory, clinical trials, and study registers)

From: Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results

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DiHAa

Diagnostic category / health problem

Author (year)

LoEb (trial design)

Number of trial participants randomised (IG, CG)

Intervention in the experimental arm

Intervention in the control arm

Follow-up (planned, max, in months)

Reported outcomes

Medical outcomes

Patient-centred structural and procedural outcomes

1

deprexis

Mental disorder / depression

Klein et al. (2016) + Klein et al. (2013) [29, 30]

Ib (RCT)

N = 1.013 (IG = 509, CG = 504)

Guidedc Web-based intervention (Deprexis)

Care as usual

6

Primary: depressive symptom severity measured by PHQ-9; Secondary: severity of depression, psychiatric diagnoses, acute suicidality measured by HDRS-24, QIDS-C16, PHQ-9; quality of life measured by SF-12

 

Mental disorder / depression

Meyer et al. (2015) [31]

Ib (RCT)

N = 163 (IG = 78, CG = 85)

Unguidedd Web-based intervention (Deprexis)

Waitlist

6

Primary: depressive symptom severity measured by PHQ-9; Secondary: anxiety symptoms, somatic complaints measured by GAD-7, PHQ-15; quality of life measured by SF-12

 

Mental disorder / depression

Berger et al. (2011) [32]

Ib (RCT)

N= 76 (IG1 = 25; IG2=25, CG = 26)

Unguided Web-based intervention (Deprexis); guided Web-based intervention (Deprexis)

Waitlist

6

Primary: depressive symptom severity measured by BDI-II; Secondary: psychological symptoms measured by 53-item BSI; interpersonal problems measured by IIP; quality of life measured by WHOQOL-BREF

 

Mental disorder / depression

Moritz et al., (2012) [26]

Ib (RCT)

N = 210 (IG = 105, CG = 105)

Unguided web-based intervention (Deprexis)

Waitlist

NA

Primary: depressive symptom severity measured by BDI; Secondary: acute suicidality measured by DAS, RSE, SBQ-R; quality of life measured by WHOQOL-BREF

 

2

elevida

Nervous system / multiple sclerosis

Pöttgen et al. (2018) [33]

Ib (RCT)

N = 275 (IG = 139, CG = 136)

Unguided web-based intervention (elevida)

Waitlist

6

Primary: severity of physical and mental fatigue measured by Chalder Fatigue Scale; Secondary: MS-specific motor and cognitive fatigue, anxiety and depression, quality of life, self-reported cognitive difficulties, activities of daily living measured by FSMC, HADS-A and HADS-D, HAQUAMS, MSNQ

 

3

HelloBetter Diabetes und Depression

Hormones and metabolism / diabetes mellitus, type 1 and 2

Nobis et al (2015) + Nobis et al. (2013) [34, 35]

Ib (RCT)

N = 260 (IG = 130, CG = 130)

Guided web- and mobile-based self-help intervention (GET.ON Mood Enhancer Diabetes)

Online unguided psychoeducation Program for depression

1

Primary: depressive symptom severity measured by CES-D; Secondary: behavioural activation, problem solving, worry, diabetes-related emotional stress, quality of life measured by HADS, PAID, AADQ, DSMQ, CSQ-8

 

4

HelloBetter Stress und Burnout

Other / difficulties in coping with life

Heber et al. (2016) [36]

Ib (RCT)

N = 264 (IG = 132, CG = 132)

Guided web- and mobile-based training (GET.ON Stress)

Waitlist

12

Primary: stress exposure measured by PSS-10; Secondary: depressive symptoms, anxiety symptoms, emotional exhaustion, sleep (severity of insomniac symptoms), work engagement, self-assessment of emotional competencies, psychological distancing from work, worries measured by CES-D, ISI, HADS-A, PSWQ-PW, SF-12, UWES, REQ-PD, TiC-P-G, ERSQ-27, ERSQ-ES-GD, CSQ-8

 

5

HelloBetter Vaginismus Plus

Mental disorder / non-organic vaginismus

Zarski et al. (2021) + Zarski et al. (2018) [37, 38]

Ib (RCT)

N = 200 (IG = 100, CG = 100)

Guided web-based intervention (eHealth platform)

Waitlist

6

Primary: improvement of vaginal penetration during sexual intercourse measured by PEQ; Secondary: non-coital vaginal penetration ability, sexual functioning, sexuality-related anxiety, penetration-related cognitions measured by PEQ, FSFI, FSQ, VPCQ

 

6

Kalmeda

Ears / tinnitus

In publication processe

Ib (RCT)

N = 187

Mobile-app “Kalmeda”

Waitlist

3

Primary: tinnitus exposure measured by mini-TQ-12; Secondary: tinnitus burden, depression tendency, stress experience and self-efficacy measured by PHQ-9, PSQ20, SWOP-K9

 

7

somnio

Mental disorder / insomnia

Lorenz et al. (2019) [39]

Ib (RCT)

N = 56 (IG = 29, CG = 27)

Unguided web-based therapy

Waitlist

12

Primary: insomnia severity measured by ISI, APSQ, SRBQ; Secondary: depression symptomatology, anxiety symptomatology, somatisation measured by BDI-II, BSI-Somatization

 

8

velibra

Mental disorder / panic and anxiety disorders

Berger et al. (2017) [40]

Ib (RCT)

N = 139 (IG = 70, CG = 69)

Unguided web-based-based cognitive–behavioural treatment (velibra)

Waitlist

6

Primary: disorder unspecific measures of anxiety, depressive symptoms, tension/stress measured by DASS-21, BAI, BDI-II; general psychopathology measured by BSI; quality of life measured by SF-12; Secondary: disorder-specific measures of anxiety measured by SPS, SIAS, ACQ, BSQ, Mobility Inventory for Agoraphobia, PSWQ, CSQ-8

Reduction of therapy-related expenses and burdens for patients and their relatives

9

Vivira

Muscles, bones and joints / koxarthrosis

In publication process

Ib (RCT)

N = 213

Mobile-app “Vivira”; therapeutic home exercise programme

Physiotherapeutic treatment, home exercise instruction

3

Primary: reduction of back pain measured by VNRS; Secondary: quality of life measured by SF-36

 

10

vorvida

Mental disorder / mental and behavioral disorders caused by alcohol

Zill et al. (2019) + Zill et al. (2016) [41, 42]

Ib (RCT)

N = 608 (IG = 306, CG = 302)

Unguided web-based intervention (vorvida)

Waitlist

6

Primary: alcohol consumption measured by QFI, TFB; Secondary: drinking behaviour (binge drinking, drunkenness) measured by Binge drinking, Drunkenness

Patient sovereignty

  1. CG control group, IG intervention group, ITT intention to treat, LoE The level of evidence, RCT randomised controlled trial, NA not available, 53-item BSI Brief Symptom Inventory, AADQ Acceptance and Action Diabetes Questionnaire, ACQ Agoraphobic Cognitions Questionnaire, APSQ Anxiety and Preoccupation about Sleep Questionnaire, BAI Beck Anxiety Inventory, BDI Beck Depression Inventory, BDI-II Beck Depression Inventory-II, BSI Brief Symptom Inventory, BSI-Somatization Somatization subscale of the Brief Symptom Inventory, BSQ Body Sensations Questionnaire, CES-D Center for Epidemiological Studies’ Depression Scale, CSQ-8 Client Satisfaction Questionnaire, DAS Dysfunctional Attitudes Scale, DASS-21 Depression Anxiety Stress Scales – Short Form, DSMQ Diabetes Self-Management Questionnaire, ERSQ-27 Emotion Regulation Skills Questionnaire, FSFI Female Sexual Functioning Index, FSMC Fatigue Scale for Motor and Cognitive Functions, FSQ Fear of Sexuality Questionnaire, GAD-7 Generalized Anxiety Disorder – 7, HADS-A, HADS-D Hospital Anxiety and Depression Scales, HAQUAMS Hamburg Quality of Life Questionnaire for MS, HDRS-24 Hamilton Depression Rating Scale, IIP Inventory of Interpersonal Problems, ISI Insomina Severity Index, mini-TQ-12  Mini-Tinnitus Questionnaire, MSNQ Multiple Sclerosis Neuropsychological Screening Questionnaire, PAID Problem Areas in Diabetes scale, PEQ Primary Endpoint Questionnaire, PHQ-15 Patient Health Questionnaire - 15 items, PHQ-9 Patient Health Questionnaire, PSS-10 Perceived Stress Scale-10, PSQ20 Perceived-Stress-Questionnaire 20 items, PSWQ Penn State Worry Questionnaire, PSWQ-PW Penn State Worry Questionnaire, Ultra Brief Version-past week, QFI The Quantity-Frequency-Index, QIDS-C16 Quick Inventory of Depressive Symptomatology, REQ-PD Recovery Experience Questionnaire, RSE Rosenberg Self-Esteem Scale, SBQ-R Suicide Behaviors Questionnaire-Revised, SF-12/36 Short-Form Health Survey- 12 or 36 items, SIAS Social Interaction Anxiety Scale, SPS Social Phobia Scale, SRBQ Sleep-related Behaviours Questionnaire, SWOP-K9 Self-Efficacy Optimism and Pessimism Questionnaire – 9 items, TFB Timeline-Follow-Back, TiC-P-G Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry, UWES Utrecht Work Engagement Scale, VNRS Verbal Numerical Rating Scale, VPCQ Vaginal Penetration Cognition Questionnaire, WHOQOL-BREF Quality of Life scale
  2. aThe contents of the table are taken from the DiGA directory [22] and the corresponding publications of trials
  3. b Based on classification according to chapter 2, section 3, § 11, Nr. 2 of the rules of procedure of the Federal Joint Committee [23]
  4. cGuided = with professional support
  5. dUnguided = without professional support
  6. eThe information on primary and secondary outcomes are taken from the DiGA directory and from the registry entry with the number DRKS00022973 available at the International Clinical Trials Registry Platform (ICTRP)