Table 2 Primary outcomes and effects of interventions (ordered by DiGA category, then alphabetically by DiGA name)
DiGA | DiGA category | Approval study (author, year) | Primary Outcome(s) | Rationale for primary outcome(s) | Outcome domain (domains of mN/psVV) | Outcome Measurement instruments (OMIs) | Outcome measurement patient self-reported | Intervention duration (in months) | Timing of post-intervention measurement (intervention duration in months) | Drop- out until post-intervention | Number of follow-ups (distance from baseline in months) | Significant between group effect at post-assessment | Between-group effect size at post-assessment | effect size according to study authors |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Kalmeda | Ears | Stover18 | Tinnitus exposure | Implicit: improvement of care; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | Tinnitus overall score as measured by Tinnitus Questionnaire (TQ) (Hiller/Göbel 2004) | Yes | 9 | During intervention (3 months) | IG: 16/94 = 17.1%; CG: 8/93 = 8.6% (without App usage) | 1 (9 months) | Yes | d calculated but not reported | N/A |
Kalmeda | Ears | Walter et al.19 | Tinnitus distress | Implicit: high prevalence of condition | Medical benefit: improvement of health | Tinnitus Questionnaire (TQ) (Göbel/Hiller 1998) | Yes | 9 | During intervention (3 months) | IG: 16/94 = 17.1%; CG: 8/93 = 8,6% | 1 (9 months) | Yes | Reduction d = 1.1 (p < 0.001) | Large |
Kranus Edera | Genitals, Kidneys, and Urinary Tract | Wiemer et al.45 | Improvement of erectile dysfunction | Implicit: clinical relevance/core symptom; implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | 5 item version of International Index of Erectile Function (IIEF-5) (Rosen, 1997, 1999); German version (Wiltink 2003) | Yes | 3 | At end of intervention (3 months) | IG: 5/122 = 4%; CG: 1/119 = 1% | No follow-up | Yes | Improvement d = 1.36 (p < 0.0001) | Large |
Kranus Edera | Genitals, Kidneys, and Urinary Tract | Wiemer et al.45 | Improvement in disease-related quality of life | Implicit: clinical relevance/core symptom; implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Medical benefit: improvement of quality of life | QoL-Med (Wagner et al. 1996), German version (Ruof et al. 2001) | Yes | 3 | At end of intervention (3 months) | IG: 5/122 = 4%; CG: 1/119 = 1% | No follow-up | Yes | Improvement d = 1.47 (p < 0.0001) | Large |
Kranus Edera | Genitals, Kidneys, and Urinary Tract | Wiemer et al.45 | Improvement of patient sovereignty/ activity | Implicit: clinical relevance/core symptom; implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Patient-relevant structural and procedural improvements: patient sovereignty | PAM-13 (Hibbard et al. 2004), German version (Brenk et al. 2013) | Yes | 3 | At end of intervention (3 months) | IG: 5/122 = 4%; CG: 1/119 = 1% | No follow-up | Yes | Improvement d = 0.96 (p < 0.0001) | Medium to large |
HelloBetter Diabetes | Hormones and Metabolism | Balzus et al.46 | Depressive symptoms | Implicit: clinical relevance/core symptom; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | Allgemeine Depressionsskala (ADS) (Hautzinger et al. 2012 a,b); Schmitt et al 2013); (engl.: CES-D, Radloff 1977; Vilagut 2016) | Yes | 2 | At end of intervention (2 months) | IG: 31/130 = 23.8%; CG: 16/130 = 12.3% | 2 (6 months and 12 months) | Yes | Reduction d = 0.94 (p < 0.001) | Large |
Oviva Direkt für Adipositas | Hormones and Metabolism | Gemesi et al.47 | Weight change | Implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | BMI (body height, body weight), body composition (bioimpedance analysis scale) (Gemesi et al.47) | No: objective measurement by study team | 3 | At end of intervention (3 months) | IG: 21/84 = 25%; CG: 8/84 = 9.5% | 1 (6 months) | Yes | Improvement difference of 2.9 kg in weight loss between IG and CG (beta = −2.9, 95% CI: −3.8;−1.9) (p < 0.001); standardized regression coefficient: 0.45–0.46 (p < 0.001) | Not reported |
zanadio | Hormones and Metabolism | Roth et al.48 | Weight change | Implicit: high prevalence of condition | Medical benefit: improvement of health | Percentage weight change from baseline (T0) to 12 months (T4) (Roth et al.48) | Yes: self-measured by participants | 12 | At end of intervention (12 months) | IG: 9/77 = 11.7%; CG: 6/73 = 8.2% | No follow-up | Yes | Weight loss; d = −1.11 (p = 0.003) | Not reported |
Kaia Rückenschmerzen | Muscles, Bones, and Joints | Priebe et al.34 | Pain intensity | Implicit: high prevalence of condition; implicit: supported by Meta-Analysis or Research Evidence | Medical benefit: improvement of health | 11 point numerical pain score (NRS) (Dworkin et al. 2005; Chiarotto et al. 2015) | Yes | 6 | At end of intervention (6 months) | IG: 253/933 = 27.2%; CG; 51/312 = 6.4% CG | 2 (timing not reported) | Yes | Reduction 33.3% (IG) vs. –14.3% (CG) (p < 0.001) | Not reported |
Vivira | Muscles, Bones, and Joints | Weise et al.49 | Back pain | Implicit: high burden or impact on quality of life | Medical benefit: improvement of health | Verbal numerical rating scale (vNRS) for nonmalignant pain (Aicher et al. 2012) | Yes | 3 | At end of intervention (3 months) | IG: 10/108 = 9.2%; CG: 6/107 = 5.6% | No follow-up | Yes | Reduction Mean difference in pain score = −2.44 (95%CI: −2.92; −1,95) (p < 0.001) | Not reported |
Elevida | Nervous System | Pöttgen et al.50 | Severity of physical and mental fatigue | Implicit: clinical relevance/core symptom | Medical benefit: improvement of health | Chalder Fatigue Scale (Cella/Chalder 2010) | Yes | 3 | At end of intervention (3 months) | IG: 36/139 = 25.8%; CG: 15/136 = 11% | 1 (6 months) | Yes | Reduction d = 0.53 (p < 0.0007) | Medium |
HelloBetter Stress and Burnout | other | Heber et al.51 | Stress exposure (perceived stress) | Implicit: high prevalence of condition | Medical benefit: improvement of health | Perceived Stress Scale PSS-10 (Cohen et al. 1983, 2006, 2009) | Yes | 1.75 | At end of intervention (7 weeks) | IG: 16/132 = 12.1%; CG: 5/132 = 3.8% | 2 (6 months and 12 months) | Yes | Reduction d = 0.83 (p < 0.001) | Large |
Deprexis | Psychology | Klein et al.16 | Depressive symptom severity | Implicit: improvement of care | Medical benefit: improvement of health | PHQ-9 (Kroenke et al., 2001) | Yes | 3 | At end of intervention (3 months) | IG: 114/509 = 22%, CG: 105/504 = 21% | 1 (6 months) | Yes | Reduction d = 0.39 (p < 0.001) | Small to medium |
Deprexis | Psychology | Meyer et al.17 | Depressive symptom severity | Implicit: improvement of care | Medical benefit: improvement of health | PHQ-9 (Gräfe et al., 2004; Kroenke et al., 2001; Löwe et al., 2004; Martin et al., 2006) | Yes | 3 | At end of intervention (3 months) | IG: 17/78 = 21.8%; CG: 12/85 = 14.1% | 1 (6 months) | Yes | Reduction d = 0.57 (p < 0.01) | Medium |
HelloBetter Panik | Psychology | Ebenfeld et al.37 | Severity of panic and agoraphobia symptoms | Implicit: high prevalence of condition | Medical benefit: improvement of health | Panic and Agoraphobia Scale (PAS) (Bandelow 1995, 1997, 2000), German version: Panik- und Agoraphobieskala | Yes | 2 | At end of intervention (2 months) | IG 4/45 = 8.8%, CG 4/47 = 8.5% | 2 (3 months and 6 months) | Yes | Reduction d = 0.66 (p = 0.002) | Medium to large |
HelloBetter Vaginismus Plus | Psychology | Zarski et al.35 | Intercourse penetration behavior | Implicit: high burden or impact on quality of life | Medical benefit: improvement of health | PEQ (van Lankveld. 2006) | Yes | 8 sessions | At end of intervention (completion of session 8 or 3 months) | IG: 22/100 = 22%; CG: 8/100 = 8% | 1 (6 months) | Yes | Improvement OR = 3.01 (95% CI: 1.46–6.18); (p < 0.01) | Not reported |
Invirto-die Therapie gegen Angst: agoraphobia | Psychology | Zurowski et al.38 | Reduction of symptoms of anxiety | Implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | Becks Anxiety Inventory (BAI) (Margraf and Ehlers, 2007) | Yes | Self-paced, approx. 2 months; optional 4 additional months | At end of intervention (2 months) | 22/103 = 21% (IG: 29.5%, CG: 3.2%) | 2 (6 months and 12 months) | Yes | Reduction d = 0.52 (p not reported) | Medium |
Invirto-die Therapie gegen Angst: panic disorder | Psychology | Zurowski et al.38 | Reduction of symptoms of anxiety | Implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | Becks Angst Inventar (BAI) (Margraf and Ehlers, 2007) | Yes | Self-paced, approx. 2 months; optional 4 additional months | At end of intervention (2 months) | 27/84 = 32.1% (IG: 43.1%, CG: 7.6%) | 2 (6 months and 12 months) | Yes | Reduction d = 0.50 (p not reported) | Medium |
Invirto-die Therapie gegen Angst: social phobia | Psychology | Zurowski et al.38 | Reduction of symptoms of anxiety | Implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | Becks Angst Inventar (BAI) (Margraf and Ehlers, 2007) | Yes | Self-paced, approx. 2 months; optional 4 additional months | At end of intervention (2 months) | 36/110 = 32.7% (IG: 44.7%, CG: 13.9%) | 2 (6 months and 12 months) | Yes | Reduction d not reported, (p not reported) | Large |
Mindable: Panik und Agoraphobie | Psychology | Helbig-Lang et al.39 | Panic and agoraphobia symptoms | Implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | Panic and agoraphobia scale (PAS) (Bandelow, 2016) | Yes | 2 | At end of intervention (2 months) | IG: 9/57 = 15.7%; CG: 1/50 = 2% | No follow-up | Yes | Reduction d = 0,7 (p < 0.001) | N/A |
Nichtraucherhelden-App | Psychology | Rupp et al.40 | Self-reported abstinence from tobacco products | Implicit: clinical relevance/core symptom; implicit: high prevalence of condition | Medical benefit: improvement of health | Self-reported abstinence from tobacco products (7-day point prevalence) | Yes | Duration of intervention not clear: no start date set; 9 core units plus optional 76 day follow-up care | At end of intervention (6 months) | IG 180/336 = 53.5%; CG 105/325 = 32.3% (until t3 = 3 M) | No follow-up | Yes | Improvement 20.2% in IG vs. 10.5% in CG at t4 OR = 2.2 (p < 0.001) | Not reported |
Novego Depressionen bewältigen | Psychology | Baumeister and Moritz42 | Change of severity of depressive symptoms | Implicit: clinical relevance/core symptom; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | BDI-II (Beck, Steer and Brown, 1996) | Yes | 3 | At end of intervention (3 months) | IG: 47/153 = 30.7%; CG: 37/150 = 24.7% | No follow-up | Yes | Reduction Hedge´s g = 0.304 (p = 0.017) | Small to medium |
Selfapys Online-Kurs bei Depression | Psychology | Krämer et al.33 | Depressive symptoms | Implicit: clinical relevance/core symptom of Condition; implicit: supported by meta-analysis or research evidence | Medical benefit: improvement of health | Beck Depression Inventory score (BDI-II) (Beck 2013) | Yes | 3 | At end of intervention (3 months) | guided: 19/151 = 12.5%; unguided: 34/150 = 22.6%; CG: 47/100 = 47% | 1 (6 months) | Yes | Reduction d = 1.63 : guided vs. control group (p < 0.001) d = 1.47 unguid-ed vs. control group (p < 0.001) | Large |
Selfapys Online-Kurs bei Generalisierter Angststörung | Psychology | Rubel et al.41 | Generalized anxiety disorder symptoms | Implicit: high prevalence of condition | Medical benefit: improvement of health | Generalized Anxiety Disorder 7 (GAD-7) (Spitzer et al. 2006) | Yes | 3 | At end of intervention (3 months) | IG: 18/8 = 23.1%; CG: 6/78 = 7.7% | No follow-up | Yes | Improvement d = 0.88 (p < 0.001) | Large |
Selfapys Online-Kurs bei Generalisierter Angststörung | Psychology | Rubel et al.41 | Well-being | Implicit: high prevalence of condition | Medical benefit: improvement of quality of life | WHO Wellbeing Index-5 (WHO-5) (Topp et al. 2015) | Yes | 3 | At end of intervention (3 months) | IG: 18/8 = 23.1%; CG: 6/78 = 7.7% | No follow-up | Yes | Increase d = 0.62 (p < 0.001) | Medium to large |
Somnio | Psychology | Lorenz et al.43 | Insomnia severity | Implicit: high burden or impact on quality of life | Medical benefit: improvement of health | Insomnia severity index (ISI) (Bastien et al., 2001) | yes | 1.5 | At end of intervention (1.5 months) | IG: 4/29 = 7%; CG: 27/27 = 0% | 1 (12 months) | Yes | Improvement d = 1.79 (p < 0.001) | Large |
Velibra | Psychology | Berger et al.44 | Reduction of anxiety and related symptoms among patients with social anxiety disorder, panic disorder with/without agoraphobia, and/or generalized anxiety disorder | Implicit: high prevalence of condition; implicit: supported by meta-analysis or research evidence | Medical benefit: improvement of health | Disorder unspecific measures of anxiety, depressive symptoms, tension/stress: BAI (Beck et al. 1988) BDI-II (Beck et al. 1996) DASS-21 (Lovibond & Lovibond, 1995) BSI (Derogatis, 1993) using the Global Severity Index (GSI) | yes (all but SCID-I) | 2.25 | At end of intervention (2.25 months) | IG: 13/70 = 19%; CG: 6/69 = 9% | 1 (6 months) | Yes | Reduction BAI: d = 0.41 (p < 0.001) BDI-II: d = 0.61 (p < 0.001) BSI-GSI: d = 0.42 (p < 0.001) DASS-21: d = 0.47 (p < 0.01) = small to medium effects | Small to medium (BAI, BSI-GSI, DASS); medium to large (BDI-II) |
Velibra | Psychology | Berger et al.44 | Quality of life | Implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Medical benefit: improvement of quality of life | SF-12 mental (Ware et al 1996) | yes | 2.25 | At end of intervention (2.25 months) | IG: 13/70 = 19%; CG: 6/69 = 9% | 1 (6 months) | Yes: SF-12 MH | Improvement SF12-MH: d = 0.49 (p < 0.001) | Small to medium |
Vorvida | Psychology | Zill et al.36 | Reduction of alcohol consumption | Implicit: high prevalence of condition; implicit: high burden or impact on quality of life | Medical benefit: improvement of health | Self-reported alcohol consumption in last 30 or 7 days according to Quantity-Frequency-Index (QFI) (Bloomfield et al. 2013; Kraus et al. 2013) and „timeline followback“-method (TFB) (Sobell/Sobell 1992) (Zill et al.36) | Yes | 6 | At end of intervention (6 months) | IG: 114/306 = 37.2%, CG: 69/303 = 22.8% | No follow-up | Yes | Reduction QFI: d = 0.34 (p < 0.001) TFB: d = 0.54 (p < 0.001) | Small to medium (QFI); medium (TFB) |
