Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep).

INTRODUCTION: It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I. METHODS AND ANALYSIS: In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Medical Centre-University of Freiburg. The results of the study will be published irrespective of the outcome. TRIAL REGISTRATION NUMBER: DRKS00021503.

A psycho-oncological online intervention supporting partners of patients with cancer (PartnerCARE): Results from a randomized controlled feasibility trial.

OBJECTIVE: Partners of cancer patients are the primary supporters and burdened at the same time. Support for partners is hitherto scarce and existing offers are rarely used. The PartnerCARE online intervention was specifically developed to address the caregiving partners' needs. This two-arm parallel randomized controlled trial (RCT) evaluates the feasibility, acceptability, and potential efficacy of PartnerCARE. METHODS: Sixty German-speaking partners of patients with various cancer entities were randomized into two conditions: intervention group (IG) with PartnerCARE (N = 30) or waitlist-control group (N = 30). Participants completed online questionnaires at baseline (T0), post-treatment (T1) and 4-months follow-up (T2). Feasibility and acceptability outcomes included dropout rates, use and acceptance of PartnerCARE, individual user/e-coach feedback as well as negative effects. Relevant efficacy outcomes were assessed to test for potential intervention effects. RESULTS: Recruitment success illustrates demand for and acceptability of PartnerCARE. Satisfaction with the intervention was high (Client Satisfaction Questionnaire adapted to Internet-based interventions, T1: M = 24.66, SD = 6.42) and 73.3% of participants completed the intervention. Study dropout rate was low (T1: 17%, T2: 29%). More positive than negative side effects of the intervention were identified, and negative ones were mainly related to "intrapersonal change". For efficacy outcomes we found effects over time, with strongest effects within the IG from T0 to T1 in psychological distress (d = 0.73, 95%-CI: [0.34; 1.12]) and anxiety (0.66, [0.26; 1.04]), but no group effects were significant at T1 and T2. CONCLUSIONS: PartnerCARE is feasible, acceptable and potentially efficacious. Based on received feedback, PartnerCARE is currently undergoing further development and subsequently efficacy will be investigated in a RCT. TRIAL REGISTRATION: German Clinical Trial Registration: DRKS00017019. Registered on 08 April 2019.

Psychological and pharmacological interventions for depression in patients with coronary artery disease.

BACKGROUND: Depression occurs frequently in individuals with coronary artery disease (CAD) and is associated with a poor prognosis. OBJECTIVES: To determine the effects of psychological and pharmacological interventions for depression in CAD patients with comorbid depression. SEARCH METHODS: We searched the CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL databases up to August 2020. We also searched three clinical trials registers in September 2021. We examined reference lists of included randomised controlled trials (RCTs) and contacted primary authors. We applied no language restrictions. SELECTION CRITERIA: We included RCTs investigating psychological and pharmacological interventions for depression in adults with CAD and comorbid depression. Our primary outcomes included depression, mortality, and cardiac events. Secondary outcomes were healthcare costs and utilisation, health-related quality of life, cardiovascular vital signs, biomarkers of platelet activation, electrocardiogram wave parameters, non-cardiac adverse events, and pharmacological side effects. DATA COLLECTION AND ANALYSIS: Two review authors independently examined the identified papers for inclusion and extracted data from the included studies. We performed random-effects model meta-analyses to compute overall estimates of treatment outcomes. MAIN RESULTS: Thirty-seven trials fulfilled our inclusion criteria. Psychological interventions may result in a reduction in end-of-treatment depression symptoms compared to controls (standardised mean difference (SMD) -0.55, 95% confidence interval (CI) -0.92 to -0.19, I2 = 88%; low certainty evidence; 10 trials; n = 1226). No effect was evident on medium-term depression symptoms one to six months after the end of treatment (SMD -0.20, 95% CI -0.42 to 0.01, I2 = 69%; 7 trials; n = 2654). The evidence for long-term depression symptoms and depression response was sparse for this comparison. There is low certainty evidence that psychological interventions may result in little to no difference in end-of-treatment depression remission (odds ratio (OR) 2.02, 95% CI 0.78 to 5.19, I2 = 87%; low certainty evidence; 3 trials; n = 862). Based on one to two trials per outcome, no beneficial effects on mortality and cardiac events of psychological interventions versus control were consistently found. The evidence was very uncertain for end-of-treatment effects on all-cause mortality, and data were not reported for end-of-treatment cardiovascular mortality and occurrence of myocardial infarction for this comparison. In the trials examining a head-to-head comparison of varying psychological interventions or clinical management, the evidence regarding the effect on end-of-treatment depression symptoms is very uncertain for: cognitive behavioural therapy compared to supportive stress management; behaviour therapy compared to person-centred therapy; cognitive behavioural therapy and well-being therapy compared to clinical management. There is low certainty evidence from one trial that cognitive behavioural therapy may result in little to no difference in end-of-treatment depression remission compared to supportive stress management (OR 1.81, 95% CI 0.73 to 4.50; low certainty evidence; n = 83). Based on one to two trials per outcome, no beneficial effects on depression remission, depression response, mortality rates, and cardiac events were consistently found in head-to-head comparisons between psychological interventions or clinical management. The review suggests that pharmacological intervention may have a large effect on end-of-treatment depression symptoms (SMD -0.83, 95% CI -1.33 to -0.32, I2 = 90%; low certainty evidence; 8 trials; n = 750). Pharmacological interventions probably result in a moderate to large increase in depression remission (OR 2.06, 95% CI 1.47 to 2.89, I2 = 0%; moderate certainty evidence; 4 trials; n = 646). We found an effect favouring pharmacological intervention versus placebo on depression response at the end of treatment, though strength of evidence was not rated (OR 2.73, 95% CI 1.65 to 4.54, I2 = 62%; 5 trials; n = 891). Based on one to four trials per outcome, no beneficial effects regarding mortality and cardiac events were consistently found for pharmacological versus placebo trials, and the evidence was very uncertain for end-of-treatment effects on all-cause mortality and myocardial infarction. In the trials examining a head-to-head comparison of varying pharmacological agents, the evidence was very uncertain for end-of-treatment effects on depression symptoms. The evidence regarding the effects of different pharmacological agents on depression symptoms at end of treatment is very uncertain for: simvastatin versus atorvastatin; paroxetine versus fluoxetine; and escitalopram versus Bu Xin Qi. No trials were eligible for the comparison of a psychological intervention with a pharmacological intervention. AUTHORS' CONCLUSIONS: In individuals with CAD and depression, there is low certainty evidence that psychological intervention may result in a reduction in depression symptoms at the end of treatment. There was also low certainty evidence that pharmacological interventions may result in a large reduction of depression symptoms at the end of treatment. Moderate certainty evidence suggests that pharmacological intervention probably results in a moderate to large increase in depression remission at the end of treatment. Evidence on maintenance effects and the durability of these short-term findings is still missing. The evidence for our primary and secondary outcomes, apart from depression symptoms at end of treatment, is still sparse due to the low number of trials per outcome and the heterogeneity of examined populations and interventions. As psychological and pharmacological interventions can seemingly have a large to only a small or no effect on depression, there is a need for research focusing on extracting those approaches able to substantially improve depression in individuals with CAD and depression.

ACTonDiabetes-a guided psychological internet intervention based on Acceptance and Commitment Therapy (ACT) for adults living with type 1 or 2 diabetes: results of a randomised controlled feasibility trial.

OBJECTIVES: This two-group randomised controlled trial evaluates the feasibility of an Acceptance and Commitment Therapy (ACT)-based internet intervention for diabetes distress in people with diabetes type 1 or type 2. Participants were assigned to a guided self-help intervention (EG) or waitlist control group (CG). SETTING: Recruitment took place following an open recruitment strategy including different diabetes centres, self-help groups and social media platforms. PARTICIPANTS: Eligibility criteria comprised being 18 years of age or older, self-reported diagnosis of type 1 or type 2 diabetes, internet access, sufficient German language skills and written informed consent. INTERVENTION: ACTonDiabetes is an internet-based and mobile-based intervention and comprises an introduction and seven modules (one module per week, processing time about 45-60 min). Intervention contents are based on ACT. PRIMARY AND SECONDARY OUTCOME MEASURES: Participants were assessed before and 8 weeks after randomisation. Primary outcome was feasibility (trial recruitment, acceptability). Potential group differences in diabetes distress and other outcomes at follow-up were analysed using linear regression models with baseline values as predictors. All analyses were based on an intention-to-treat principle, potential negative effects were analysed on per-protocol basis. RESULTS: From October 2017 to April 2018, N=42 people with diabetes consented and were randomised (EG n=21, CG n=21). Forty-three per cent of the EG completed all treatment modules within 8 weeks. Across modules, formative user feedback revealed that contents could be optimised regarding comprehensibility (34%), individualisation (20%) and text amount (21%). Overall, 57% of participants dropped out prior to full treatment completion. There were reductions of diabetes distress in the EG (d=0.65, p=0.042). CONCLUSIONS: Modifications of the intervention content according to the user feedback will be performed to further improve acceptability. Mechanisms to foster intervention adherence should be considered for lowering the attrition rate. ACTonDiabetes is feasible for the implementation in a confirmatory trial. TRIAL REGISTRATION NUMBER: WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS) (DRKS00013193).

Clinical and Cost-Effectiveness of PSYCHOnlineTHERAPY: Study Protocol of a Multicenter Blended Outpatient Psychotherapy Cluster Randomized Controlled Trial for Patients With Depressive and Anxiety Disorders.

Introduction: Internet- and mobile-based interventions (IMIs) and their integration into routine psychotherapy (i.e., blended therapy) can offer a means of complementing psychotherapy in a flexible and resource optimized way. Objective: The present study will evaluate the non-inferiority, cost-effectiveness, and safety of two versions of integrated blended psychotherapy for depression and anxiety compared to standard cognitive behavioral therapy (CBT). Methods: A three-armed multicenter cluster-randomized controlled non-inferiority trial will be conducted comparing two implementations of blended psychotherapy (PSYCHOnlineTHERAPYfix/flex) compared to CBT. Seventy-five outpatient psychotherapists with a CBT-license will be randomized in a 1:1:1 ratio. Each of them is asked to include 12 patients on average with depressive or anxiety disorders resulting in a total sample size of N = 900. All patients receive up to a maximum of 16 psychotherapy sessions, either as routine CBT or alternating with Online self-help sessions (fix: 8/8; flex: 0-16). Assessments will be conducted at patient study inclusion (pre-treatment) and 6, 12, 18, and 24 weeks and 12 months post-inclusion. The primary outcome is depression and anxiety severity at 18 weeks post-inclusion (post-treatment) using the Patient Health Questionnaire Anxiety and Depression Scale. Secondary outcomes are depression and anxiety remission, treatment response, health-related quality of life, patient satisfaction, working alliance, psychotherapy adherence, and patient safety. Additionally, several potential moderators and mediators including patient characteristics and attitudes toward the interventions will be examined, complemented by ecological day-to-day digital behavior variables via passive smartphone sensing as part of an integrated smart-sensing sub-study. Data-analysis will be performed on an intention-to-treat basis with additional per-protocol analyses. In addition, cost-effectiveness and cost-utility analyses will be conducted from a societal and a public health care perspective. Additionally, qualitative interviews on acceptance, feasibility, and optimization potential will be conducted and analyzed. Discussion: PSYCHOnlineTHERAPY will provide evidence on blended psychotherapy in one of the largest ever conducted psychotherapy trials. If shown to be non-inferior and cost-effective, PSYCHOnlineTHERAPY has the potential to innovate psychotherapy in the near future by extending the ways of conducting psychotherapy. The rigorous health care services approach will facilitate a timely implementation of blended psychotherapy into standard care. Trial Registration: The trial is registered in the German Clinical Trials Register (DRKS00023973; date of registration: December 28th 2020).

Feasibility of a Software agent providing a brief Intervention for Self-help to Uplift psychological wellbeing ("SISU"). A single-group pretest-posttest trial investigating the potential of SISU to act as therapeutic agent.

BACKGROUND: Software agents are computer-programs that conduct conversations with a human. The present study evaluates the feasibility of the software agent "SISU" aiming to uplift psychological wellbeing. Methods: Within a one-group pretest-posttest trial, N = 30 German-speaking participants were recruited. Assessments took place before (t1), during (t2) and after (t3) the intervention. The ability of SISU to guide participants through the intervention, acceptability, and negative effects were investigated. Data analyses are based on intention-to-treat principles. Linear mixed models will be used to investigate short-term changes over time in mood, depression, anxiety. INTERVENTION: The intervention consists of two sessions. Each session comprises writing tasks on autobiographical negative life events and an Acceptance- and Commitment Therapy-based exercise respectively. Participants interact with the software agent on two consecutive days for about 30 min each. RESULTS: All participants completed all sessions within two days. User experience was positive, with all subscales of the user experience questionnaire (UEQ) M > 0.8. Participants experienced their writings as highly self-relevant and personal. However, 57% of the participants reported at least one negative effect attributed to the intervention. Results on linear mixed models indicate an increase in anxiety over time (ß = 1.33, p = .001). Qualitative User Feedback revealed that the best thing about SISU was its innovativeness (13%) and anonymity (13%). As worst thing about SISU participants indicated that the conversational style of SISU often felt unnatural (73%). CONCLUSION: SISU successfully guided participants through the two-day intervention. Moreover, SISU has the potential to enter the inner world of participants. However, intervention contents have the potential to evoke negative effects in individuals. Expectable short-term symptom deterioration due to writing about negative autobiographical life events could not be prevented by acceptance and commitment therapy-based exercises. Hence, results suggest a revision of intervention contents as well as of the conversational style of SISU. The good adherence rate indicates the useful and acceptable format of SISU as a mental health chatbot. Overall, little is known about the effectiveness of software agents in the context of psychological wellbeing. Results of the present trial underline that the innovative technology bears the potential of SISU to act as therapeutic agent but should not be used with its current intervention content. TRIAL-REGISTRATION: The Trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Register (DRKS): DRKS00014933 (date of registration: 20.06.2018). Link: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014933.

Lessons learned from an attempted randomized-controlled feasibility trial on "WIDeCAD" - An internet-based depression treatment for people living with coronary artery disease (CAD).

Despite the high prevalence of comorbid depression in people living with coronary artery disease (CAD), uptake of psychological treatment is generally low. This study was designed to investigate the feasibility of an internet-based cognitive-behavioral (iCBT) depression intervention for people with CAD and depressive symptoms. METHODS: People with CAD and depressive symptoms (PHQ-9 ≥ 5) were randomly assigned to the eight modules comprising iCBT (N = 18), or waitlist-control (N = 16). Measures were taken at baseline (t1) and at post-treatment (eight weeks after randomization, t2). Feasibility-related outcomes were recruitment strategy, study attrition, intervention dropout, satisfaction, negative effects as well as the potential of the intervention to affect likely outcomes in a future full-scale trial (depression, anxiety, quality of life, fear of progression). Data analyses were based on intention-to-treat principles. Linear regression models were used to detect between group differences. Linear Mixed Models were used to model potential changes over time. RESULTS: This trial was terminated prior to a-priori defined sample size has been reached given low recruitment success as well as high intervention dropout (88%) and study attrition (23%). On average, participants in the intervention group completed M = 2.78 (SD = 3.23) modules. Participants in the waitlist control group barely started one module (M = 0.82, SD = 1.81). The satisfaction with the intervention was low (M = 20.6, SD = 0.88). Participants reported no negative effects attributed to the iCBT. Differences between groups with regard to depression, anxiety, fear of progression and quality of life remained non-significant (p > 0.05). CONCLUSION: This trial failed to recruit a sufficient number of participants. Future work should explore potential pitfalls with regards to the reach and persuasiveness of internet interventions for people living with CAD. The study gives important indications for future studies with regard to the need for new ideas to reach and treat people with CAD and depression.

Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being.

INTRODUCTION: Only a minority of people living with mental health problems are getting professional help. As digitalisation moves on, the possibility of providing internet/mobile-based interventions (IMIs) arises. One type of IMIs are fully automated conversational software agents (chatbots). Software agents are computer programs that can hold conversations with a human by mimicking a human conversational style. Software agents could deliver low-threshold and cost-effective interventions aiming at promoting psychological well-being in a large number of individuals. The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group. METHODS AND ANALYSIS: Within a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. SISU is based on therapeutic writing and acceptance and commitment therapy-based principles. The brief intervention consists of three modules. Participants work through the intervention on 3 consecutive days. Assessment takes place before (t1), during (t2) and after (t3) the interaction with SISU, as well as 4 weeks after randomisation (t4). Primary outcome is psychological well-being (WHO-5). Secondary outcomes are emotional well-being (Flourishing Scale), psychological flexibility (Acceptance and Action Questionnaire-II), quality of life (Assessment of Quality of Life -8D), satisfaction with the intervention (Client Satisfaction Questionnaire-8) and side effects (Inventory for the assessment of negative effectsof psychotherapy). Examined mediators and moderators are sociodemographic variables, personality (Big Five Inventory-10), emotion regulation (Emotion Regulation Questionnaire), alexithymia (Toronto Alexithymia Scale-20), centrality of events (Centrality of Events Scale), treatment expectancies (Credibility Expectancy Questionnaire) and technology alliance (Inventory of Technology Alliance-Online Therapy). Data analysis will be based on intention-to-treat principles. SISU guides participants through a 3-day intervention. ETHICS AND DISSEMINATION: This trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). Results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS): DRKS00016799 (date of registration: 25 April 2019). In case of important protocol modifications, trial registration will be updated. This is protocol version number 1.

Validation of the Mobile Application Rating Scale (MARS).

BACKGROUND: Mobile health apps (MHA) have the potential to improve health care. The commercial MHA market is rapidly growing, but the content and quality of available MHA are unknown. Instruments for the assessment of the quality and content of MHA are highly needed. The Mobile Application Rating Scale (MARS) is one of the most widely used tools to evaluate the quality of MHA. Only few validation studies investigated its metric quality. No study has evaluated the construct validity and concurrent validity. OBJECTIVE: This study evaluates the construct validity, concurrent validity, reliability, and objectivity, of the MARS. METHODS: Data was pooled from 15 international app quality reviews to evaluate the metric properties of the MARS. The MARS measures app quality across four dimensions: engagement, functionality, aesthetics and information quality. Construct validity was evaluated by assessing related competing confirmatory models by confirmatory factor analysis (CFA). Non-centrality (RMSEA), incremental (CFI, TLI) and residual (SRMR) fit indices were used to evaluate the goodness of fit. As a measure of concurrent validity, the correlations to another quality assessment tool (ENLIGHT) were investigated. Reliability was determined using Omega. Objectivity was assessed by intra-class correlation. RESULTS: In total, MARS ratings from 1,299 MHA covering 15 different health domains were included. Confirmatory factor analysis confirmed a bifactor model with a general factor and a factor for each dimension (RMSEA = 0.074, TLI = 0.922, CFI = 0.940, SRMR = 0.059). Reliability was good to excellent (Omega 0.79 to 0.93). Objectivity was high (ICC = 0.82). MARS correlated with ENLIGHT (ps<.05). CONCLUSION: The metric evaluation of the MARS demonstrated its suitability for the quality assessment. As such, the MARS could be used to make the quality of MHA transparent to health care stakeholders and patients. Future studies could extend the present findings by investigating the re-test reliability and predictive validity of the MARS.

PartnerCARE-a psycho-oncological online intervention for partners of patients with cancer: study protocol for a randomised controlled feasibility trial.

INTRODUCTION: Cancer burdens not only the patient but also the partner to a comparable extent. Partners of patients with cancer are highly involved in the caring process and therefore often experience distress and report a low quality of life. Interventions for supporting partners are scarce. Existing ones are rarely used by partners because they are often time-consuming per se and offer only limited flexibility with regard to schedule and location. The online intervention PartnerCARE has been developed on the basis of caregiver needs and consists of six consecutive sessions and four optional sessions, which are all guided by an e-coach. The study aims to evaluate feasibility and acceptance of the online intervention PartnerCARE and the related trial process. In addition, first insights of the putative efficacy of PartnerCARE should be gained. METHODS AND ANALYSIS: A two-arm parallel-group randomised controlled trial will be conducted to compare the PartnerCARE online intervention with a waitlist control group. The study aims to recruit in total n=60 partners of patients with any type of cancer across different access paths (eg, university medical centres, support groups, social media). Congruent with feasibility study objectives, the primary outcome comprises recruitment process, study procedure, acceptance and satisfaction with the intervention (Client Satisfaction Questionnaire adapted to Internet-based interventions), possible negative effects (Inventory of Negative Effects in Psychotherapy) and dropout rates. Secondary outcomes include quality of life, distress, depression, anxiety, caregiver burden, fear of progression, social support, self-efficacy, coping and loneliness. Online measurements will be performed by self-assessment at three time points (baseline/pre-randomisation, 2 months and 4 months after randomisation). Data analyses will be based on intention-to-treat principle. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Ethics Committee of the University of Ulm (No 390/18). Results from this study will be disseminated to relevant healthcare communities, in peer-reviewed journals and at scientific and clinical conferences. TRIAL REGISTRATION NUMBER: DRKS00017019.

Internet- Based Interventions in Chronic Somatic Disease.

BACKGROUND: Clinical guidelines recommend psychosocial care as an integral part of medical treatment, but access is often limited. Technology-based approaches provide an attractive opportunity to optimize health outcomes and quality of life in people with chronic somatic diseases e.g. by means of Internet- and mobile-based interventions (IMIs). The present article provides an overview on the basics of IMIs, applications and their evidence base for people living with chronic somatic diseases. METHODS: We conducted a selective literature search in the PubMed and Cochrane databases. Reviews which included randomized controlled trials investigating psychological IMIs were discussed pertaining to their relevance for the population described. RESULTS: IMIs lead to a change in unfavorable behavior connected to chronic somatic diseases. IMIs can foster protective factors like balanced physical activity or risk factors like smoking or alcohol consumption. However, studies reveal small effect sizes of d=0.25 for physical activity and an averaged effect size of d=0.20 for smoking and alcohol consumption. Additionally, IMIs can be used for the (co-)treatment of chronic somatic diseases, for instance to increase disease-specific selfefficacy in patients with diabetes (d=0.23). Studies included in meta-analyses are often highly heterogenous and are investigated in research contexts with limited health care services relevance. CONCLUSION: IMIs are potentially effective when aiming at lifestyle changes and supporting medical treatment in people with chronic somatic diseases. However, results are still heterogenous and the evidence base is limited regarding specific settings, compounding the discussion of possible ways of implementing IMIs into our healthcare systems.

Effects of existential interventions on spiritual, psychological, and physical well-being in adult patients with cancer: Systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: To synthesize the evidence of existential interventions in adult patients with cancer. METHODS: Embase, MEDLINE, CENTRAL, CINAHL, PsycINFO, PSYNDEX, and the WHO ICTRP were searched up until 26 January 2018. Eligibility criteria for studies were (1) adult patients with cancer, (2) evaluation of existential interventions, (3) compared with active/non-active control, (4) assessing relevant spiritual, psychological, or physical outcomes, and (5) conducted as randomized controlled trials. Standardized mean differences (Hedges' g) were calculated, and meta-analyses were conducted using random effects models. Effects were aggregated within four time horizons (post-treatment; ≤3 months; ≤6 months; >6 months). Heterogeneity was assessed by forest plots and I2 . Risk of bias was assessed using the Cochrane Risk of Bias Tool. This review has been registered with Prospero (CRD42016042895). RESULTS: A total of 3461 records were identified, of which 30 unique studies (3511 participants) were included in the review and 24 studies were included in meta-analyses. Existential interventions showed significant effects on existential well-being (g = 0.52; CI[0.13; 0.91; k = 10; I2  = 85%) and quality of life (g = 0.21; CI[0.01; 0.42]; k = 17; I2  = 75%) at post-treatment, on hope at post-treatment (g = 0.43; CI[0.12; 0.74]; k = 12; I2  = 86%) and after 6 months (g = 0.25; CI[0.02; 0.48]; k = 3; I2  = 0%) and on self-efficacy at post-treatment (g = 0.50; CI[0.09; 0.90]; k = 2; I2  = 0%). No significant effects were found on the remaining outcomes and time points. Significant moderator effects were found for professional background of therapists, intervention concept, number of sessions, and setting. CONCLUSIONS: This systematic review and meta-analysis provides evidence that adult patients with cancer across all stages and types benefit from existential interventions. Future research should strive towards a higher standardization in particular with respect to outcome assessments.