A fully automated conversational agent for promoting mental well-being: A pilot RCT using mixed methods.

Fully automated self-help interventions can serve as highly cost-effective mental health promotion tools for massive amounts of people. However, these interventions are often characterised by poor adherence. One way to address this problem is to mimic therapy support by a conversational agent. The objectives of this study were to assess the effectiveness and adherence of a smartphone app, delivering strategies used in positive psychology and CBT interventions via an automated chatbot (Shim) for a non-clinical population - as well as to explore participants' views and experiences of interacting with this chatbot. A total of 28 participants were randomized to either receive the chatbot intervention (n = 14) or to a wait-list control group (n = 14). Findings revealed that participants who adhered to the intervention (n = 13) showed significant interaction effects of group and time on psychological well-being (FS) and perceived stress (PSS-10) compared to the wait-list control group, with small to large between effect sizes (Cohen's d range 0.14-1.06). Also, the participants showed high engagement during the 2-week long intervention, with an average open app ratio of 17.71 times for the whole period. This is higher compared to other studies on fully automated interventions claiming to be highly engaging, such as Woebot and the Panoply app. The qualitative data revealed sub-themes which, to our knowledge, have not been found previously, such as the moderating format of the chatbot. The results of this study, in particular the good adherence rate, validated the usefulness of replicating this study in the future with a larger sample size and an active control group. This is important, as the search for fully automated, yet highly engaging and effective digital self-help interventions for promoting mental health is crucial for the public health.

Guided and unguided Acceptance and Commitment Therapy for social anxiety disorder and/or panic disorder provided via the Internet and a smartphone application: A randomized controlled trial.

Acceptance and Commitment Therapy (ACT) can be effective in treating anxiety disorders, yet there has been no study on Internet-delivered ACT for social anxiety disorder (SAD) and panic disorder (PD), nor any study investigating whether therapist guidance is superior to unguided self-help when supplemented with a smartphone application. In the current trial, n=152 participants diagnosed with SAD and/or PD were randomized to therapist-guided or unguided treatment, or a waiting-list control group. Both treatment groups used an Internet-delivered ACT-based treatment program and a smartphone application. Outcome measures were self-rated general and social anxiety and panic symptoms. Treatment groups saw reduced general (d=0.39) and social anxiety (d=0.70), but not panic symptoms (d=0.05) compared to the waiting-list group, yet no differences in outcomes were observed between guided and unguided interventions. We conclude that Internet-delivered ACT is appropriate for treating SAD and potentially PD. Smartphone applications may partially compensate for lack of therapist support.

Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial.

BACKGROUND: There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment--including four face-to-face sessions and a smartphone application--was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression. METHODS: This was a randomised controlled non-inferiority trial (NCT01819025) comparing a blended treatment (n=46) against a full ten-session treatment (n=47) for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment. RESULTS: Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen's d=1.35; CI [-0.82, 3.52] to d=1.47; CI [-0.41, 3.35]; between group d=-0.13 CI [-2.37, 2.09] and d=-0.10 CI [-2.53, 2.33]). At the same time, the blended treatment reduced the therapist time with an average of 47%. CONCLUSIONS: We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone application as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression. TRIAL REGISTRATION: Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025.

Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial.

OBJECTIVES: Evaluating and comparing the effectiveness of two smartphone-delivered treatments: one based on behavioural activation (BA) and other on mindfulness. DESIGN: Parallel randomised controlled, open, trial. Participants were allocated using an online randomisation tool, handled by an independent person who was separate from the staff conducting the study. SETTING: General community, with recruitment nationally through mass media and advertisements. PARTICIPANTS: 40 participants diagnosed with major depressive disorder received a BA treatment, and 41 participants received a mindfulness treatment. 9 participants were lost at the post-treatment. INTERVENTION BA: An 8-week long behaviour programme administered via a smartphone application. Mindfulness: An 8-week long mindfulness programme, administered via a smartphone application. MAIN OUTCOME MEASURES: The Beck Depression Inventory-II (BDI-II) and the nine-item Patient Health Questionnaire Depression Scale (PHQ-9). RESULTS: 81 participants were randomised (mean age 36.0 years (SD=10.8)) and analysed. Results showed no significant interaction effects of group and time on any of the outcome measures either from pretreatment to post-treatment or from pretreatment to the 6-month follow-up. Subgroup analyses showed that the BA treatment was more effective than the mindfulness treatment among participants with higher initial severity of depression from pretreatment to the 6-month follow-up (PHQ-9: F (1, 362.1)=5.2, p<0.05). In contrast, the mindfulness treatment worked better than the BA treatment among participants with lower initial severity from pretreatment to the 6-month follow-up (PHQ-9: F (1, 69.3)=7.7, p<0.01); BDI-II: (F(1, 53.60)=6.25, p<0.05). CONCLUSIONS: The two interventions did not differ significantly from one another. For participants with higher severity of depression, the treatment based on BA was superior to the treatment based on mindfulness. For participants with lower initial severity, the treatment based on mindfulness worked significantly better than the treatment based on BA. TRIAL REGISTRATION: Clinical Trials NCT01463020.

Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial.

BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effects of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a smartphone application. The effect of added therapist support will also be studied. METHODS/DESIGN: One hundred and fifty participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to either one of three study groups: 1, smartphone-supplemented iCBT with therapist support; 2, smartphone-supplemented iCBT without therapist support; or 3, an active waiting list control group with delayed treatment. Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment (days 24 and 48) and two follow-up assessments (12 and 36 months) to assess rapid and long-term effects. DISCUSSION: To our knowledge, this is the first study to investigate the effectiveness of smartphone-supplemented iCBT for anxiety disorders. Hence, the findings from this trial will constitute great advancements in the burgeoning and promising field of smartphone-administered psychological interventions. Limitations are discussed. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01963806.

Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial.

BACKGROUND: The need for cost-effective interventions for people suffering from major depressive disorders is essential. Behavioral activation is an intervention that can largely benefit from the use of new mobile technologies (for example smartphones). Therefore, developing smartphone-based behavioral activation interventions might be a way to develop cost-effective treatments for people suffering from major depressive disorders. The aim of this study will be to test the effects of a smartphone-delivered behavioral activation treatment. METHODS: The study will be a randomized controlled trial with a sample size of 120 participants, with 60 patients in each group. The treatment group includes an 8-week smartphone-based behavioral activation intervention, with minimal therapist contact. The smartphone-based intervention consists of a web-based psychoeducation, and a smartphone application. There is also a back-end system where the therapist can see reports from the patients or activities being reported. In the attention control group, we will include brief online education and then recommend use of a smartphone application that is not directly aimed at depression (for example, 'Effective meditation'). The duration of the control condition will also be 8 weeks. For ethical reasons we will give the participants in the control group access to the behavioral activation treatment following the 8-week treatment period. DISCUSSIONS: We believe that this trial has at least three important implications. First, we believe that smartphones can be integrated even further into society and therefore may serve an important role in health care. Second, while behavioral activation is a psychological treatment approach for which there is empirical support, the use of a smartphone application could serve as the therapist's prolonged arm into the daily life of the patient. Third, as we have been doing trials on guided Internet treatment for more than 10 years it is now time to move to the next generation of information technology - smartphones - which are not only relevant for Swedish conditions but also for developing countries in the world which are increasingly empowered by mobile phones with Internet connection. TRIAL REGISTRATION: ClinicalTrials.gov NCT01463020.

Development and initial evaluation of a smartphone application based on acceptance and commitment therapy.

BACKGROUND: An intervention, consisting of an ACT-based smartphone-application and a web-based psychoeducation, has been developed. The smartphone-application, together with the psychoeducation, aims to function as a self-help intervention for living consistently with one's values. The study is an exploratory investigation of this new smartphone-based tool. CASE DESCRIPTION: Primarily, the study aims at investigating a new field, providing a basis for generating hypotheses for further research. The first aim of this initial, exploratory study was to examine if this intervention had an effect on the variables of: valued actions, psychological flexibility, and life satisfaction as well as the states of depression, anxiety and stress, for a non-clinical sample of 11 Swedish Iphone users. This was made with a quasi-experimental pretest-posttest design without control group. The second aim was to investigate how the participants experienced the intervention, as measured by a qualitative questionnaire. DISCUSSION AND EVALUATION: The group analyses showed that the participants increased their valued action and psychological flexibility significantly during the intervention. Furthermore, value-based actions and psychological flexibility showed small effect sizes when comparing pretest and posttest score. However, the design of the study makes it impossible to draw any certain conclusions. The qualitative questionnaire showed a general positive experience of the intervention. CONCLUSIONS: The results from the present study indicated that the intervention should be studied further. The findings also generated a number of hypotheses that could be investigated in further research.