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Mental disorders have become a major health issue, and a substantial number of afflicted individuals do not get appropriate treatment. Web-based interventions are promising supplementary tools for improving health care for patients with mental disorders, as they can be delivered at low costs and used independently of time and location. Although psychodynamic treatments are used frequently in the face-to-face setting, there has been a paucity of studies on psychodynamic Web-based self-help interventions.
The objective of this study was to determine the feasibility and preliminary efficacy of a transdiagnostic affect-focused psychodynamic Web-based self-help intervention designed to increase emotional competence of patients with mental disorders.
A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups. Following discharge, the intervention group (IG) got access to a guided version of the intervention for 10 weeks. After a waiting period of 10 weeks, the wait-list control group (WLCG) got access to an unguided version of the intervention. We reported the assessments at the beginning (T0) and at the end of the intervention, resp. the waiting period (T1). The primary outcome was satisfaction with the treatment at T1. Secondary outcome measures included emotional competence, depression, anxiety, and quality of life. Statistical analyses were performed with descriptive statistics (primary outcome) and analysis of covariance; a repeated measurement analysis of variance was used for the secondary outcomes. Effect sizes were calculated using Cohen
Patients were chronically ill, diagnosed with multiple diagnoses, most frequently with depression (84%, 58/69), anxiety (68%, 47/69), personality disorder (38%, 26/69), and depersonalization-derealization disorder (22%, 15/69). A majority of the patients (86%, 36/42) logged into the program, of which 86% (31/36) completed the first unit. Satisfaction with the units mastered was rated as good (52%, 16/31) and very good (26%, 9/31). However, there was a steady decline of participation over the course of the program; only 36% of the participants (13/36) participated throughout the trial completing at least 50% of the sessions. According to the ITT analysis, participants improved statistically significantly and with moderate effect sizes (Cohen
Although overall program satisfaction and benefit of the program were favorable with respect to the indicators of emotional disorders, the rate of completion was low. Our findings point to the need to target the intervention more specifically to the needs and capabilities of participants and to the context of the intervention.
Clinicaltrials.gov NCT02671929; https://clinicaltrials.gov/ct2/show/NCT02671929 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb)
Mental disorders have become a major health issue worldwide. According to Jacobi et al [
Web-based interventions have been considered promising supplementary tools, as they can be delivered at low costs and used independently of time and location [
Web-based self-help interventions have been used in different clinical contexts, for example, self-help for participants with mild to moderate severity of mental complaints [
Although participants recruited over the Internet fared well, applicability of Web-based self-help interventions for primary care patients has been mixed. Gilbody et al [
In Germany, inpatient psychotherapy is indicated when outpatient psychotherapy has not been sufficient, and severe or multimorbid mental disorders significantly impair activities of daily living and work ability [
Although psychodynamic methods are used frequently in outpatient and inpatient treatments in the face-to-face setting [
Efficacy and effectiveness have been proved for psychodynamic psychotherapies for different disorders [
Johansson et al [
The primary goal of this study was to test the feasibility of a psychodynamic Web-based self-help intervention for psychosomatic inpatients. For this purpose, we translated and adapted the self-help book
Beyond that, we wanted to gather first hints of efficacy of the intervention regarding emotional competence, depression, and anxiety with an RCT.
On the basis of a previous study [
Furthermore, we expected the participants of the IG to show significantly higher emotional competence, lower depression, and anxiety scores at the end of the intervention compared with the participants of the control group.
Becker et al [
The intervention was based on the self-help book
In this book, 8 units—corresponding to the chapters—cover four steps: enhancing awareness of one’s emotions and related defenses, regulating the anxiety that emerges when feared emotions are approached, fully experiencing, and mindfully expressing emotions to other people [
Upon discharge from inpatient or day clinic treatment, the IG got access to the intervention for 10 weeks when they first logged onto the platform (
The study was performed using a wait-list control design to evaluate the efficacy of the intervention developed. Patients in the wait-list control group (WLCG) started their intervention 10 weeks after discharge from inpatient or day hospital treatment, when the intervention of the IG had ended. Additionally, the WLCG received an unguided version of the intervention and therefore did not receive feedback from a Web-based therapist (to be analyzed separately).
All questionnaires were given online. Assessments were performed at discharge from the clinic (T0), at the end of the intervention of the IG (T1), 2 months later for follow-up assessment (T2; only IG), and at the end of the intervention of the WLCG (T3; only WLCG).
Satisfaction with the intervention in the IG as the primary endpoint was measured with one item of the German version of the Client Satisfaction Questionnaire (CSQ-8) [
Additionally, we assessed satisfaction on a weekly basis with the item “Please rate the unit as a whole.” on a 5-point Likert scale (“very good,” “good,” “satisfactory,” “bad,” “very bad”).
Additionally, participants rated their satisfaction with each unit completed on a 5-point Likert scale from “bad” to “very good.”
Emotional competence was assessed with the German version of the 27-item Emotion-Regulation Skills Questionnaire (ERSQ) [
The Patient Health Questionnaire-9 (PHQ-9) [
Anxiety was assessed by the General Anxiety Disorder-7 (GAD-7) [
Depersonalization was assessed with the 2-item version of the Cambridge Depersonalization Scale (CDS-2) [
Quality of life was measured with the reliable and valid European Health Interview Survey Quality of Life 8-item index (EUROHIS-QOL-8) [
The Rosenberg Self-Esteem Scale (RSE) [
The subjective prognosis of gainful employment (SPE) [
The 8-item Somatic Symptom Scale (SSS-8) [
Symptoms of depression and anxiety were measured after completing every unit with the PHQ-4 [
Completion of units was determined objectively on the basis of entries in the database of the platform.
The primary outcome was evaluated with descriptive statistics. Secondary outcomes were analyzed by analysis of covariance (ANCOVA) controlling outcome variables by their baseline scores and a repeated measurement analysis of variance (ANOVA) for the weekly assessment of the PHQ-4. With the participants’ written consent, diagnoses were taken from the clinical documentation of the Department of Psychosomatic Medicine and Psychotherapy. Effect sizes were calculated transforming the eta-squared from ANCOVA into Cohen
As this was a feasibility study, no power analysis was conducted. Over the course of 20 weeks (from September 2015 to February 2016), consecutive patients (inpatient and day hospital) treated at the Department of Psychosomatic Medicine and Psychotherapy were invited to participate in the trial. As the clinic treats about 390 inpatients per year and we assumed a participation rate of approximately 30% [
Randomization of participants and storing of personal data were conducted by the Study Center of Mental Disorders at the University Medical Center Mainz. Management of the study, administration of the Internet platform, and therapeutic feedback for the patients in the IG were performed by psychologists of the Department of Psychosomatic Medicine and Psychotherapy. A firewall-protected Web server using a secure sockets layer–encrypted access to the platform itself and the database containing the log-in information hosted the study platform. All questionnaires were administered Web-based with SoSci Survey [
The Ethics Committee of the Statutory Physician Board of the State of Rhineland-Palatinate approved the clinical protocol and written informed consent (Ref. No. 837.299.15-10067), and all procedures described in the clinical trial protocol (ClinicalTrials.gov Identifier: NCT02671929) follow the ICH-GCP guidelines and ethical principles described in the current revision of the Declaration of Helsinki. Local legal and regulatory requirements were abided.
A total of 82 participants were randomized to IG or WLCG. In addition, 86% (36/42) of the IG logged into the platform (values for WLCG were similar), and another 86% (31/36) completed the first unit. Nonstarters (IG: n=6; WLCG: n=7) were more often male than female (53.8% vs 46.2%) and more likely to be part-time employed than starters but not on a statistical significant level.
Furthermore, 7 patients dropped out, 4 from the IG and 3 from the WLCG group; the reasons that they named were health problems (n=3), lack of time (n=2), and problems of dealing with the Web-based intervention (n=1), and one patient gave no response. Dropouts were older (mean 50.80, SD 7.92 vs mean 39.06, SD 14.36) than participants (
Participants who completed the T1 assessment did not differ from those participants who dropped out concerning sociodemographic characteristics and baseline mental symptoms. For all outcome analyses, patients were excluded when the baseline assessment (T0) was missing (n=13). A total of 69 participants were analyzed after substituting in the missing data based on LOCF.
In the IG, 13 participants completed the intervention, that is, logged into the intervention continuously for 10 weeks and finished at least 50% of the units.
The majority of participants were female and unmarried; mean age was 40 years (IG: mean 38.92, SD 12.66; WLCG: mean 41.00, SD 16.00). Despite good education, only slightly over half of them were working or in training. Most frequent main diagnoses were affective, anxiety, and personality disorders, followed by depersonalization-derealization disorder and somatoform disorders. Substance abuse, eating disorders, and obsessive-compulsive disorders, etc, were classified as “others” in the table according to the International Statistical Classification of Diseases, Tenth Revision [
As the baseline data (T0) in
The majority was mostly (57%, 12/21) or very satisfied (38%, 8/21); only one participant (5%, 1/21) was slightly dissatisfied (based on the one item of the CSQ-8). Asked whether they would do the Web-based self-help program once more if they needed help, more than half of the participants (57%, 12/21) said “definitely yes,” about one third (29%, 6/21) said, “I believe so,” and only few (14%, 3/21) answered, “I do not believe so.” As overall satisfaction in the CSQ-8 at T1 was only rated by a small proportion of participants who had completed assessments at termination (n=21), we also analyzed ratings of the quality of the units mastered in the Web-based self-help program. For this purpose, we used the ratings for the last session completed by each participant. On the basis of total 31 responses, satisfaction was judged as very good (29%, 9/31), good (52%, 16/31), satisfactory (16%, 5/31), and bad (3%, 1/31). Thus, overall satisfaction exceeded our expectations of 75%.
The total score of the CSQ-8 in the IG (mean 26.33, SD 2.89) was above the cut-off (24.5), which indicates a high treatment satisfaction as calculated in a large sample of inpatients of psychosomatic rehabilitation [
Psychological complaints in the course of the intervention assessed with the PHQ-4 did not change over time in the IG using a repeated measurement ANOVA with LOCF (
The CONSORT (Consolidated Standards of Reporting Trials) flow diagram.
Demographic and medical data of study participants.
Demographic and medical data | IGa (n=36), |
WLCGb (n=33), |
Total (N=69)c, |
|
Female | 29 (81) | 20 (61) | 49 (71) | |
Male | 7 (19) | 13 (39) | 20 (29) | |
Single | 23 (64) | 19 (61) | 42 (63) | |
Married | 8 (22) | 9 (29) | 17 (25) | |
Separated, divorced, widowed | 5 (14) | 3 (10) | 8 (12) | |
No, lower, or other graduation | 6 (17) | 1 (4) | 7 (11) | |
Middle secondary | 9 (25) | 16 (51) | 25 (37) | |
Higher secondary | 21 (58) | 14 (45) | 35 (52) | |
Full-time | 13 (36) | 7 (21) | 20 (29) | |
Part-time | 7 (19) | 4 (12) | 11 (16) | |
Apprenticeship | 4 (11) | 1 (3) | 5 (7) | |
Retired | 3 (8) | 3 (9) | 6 (9) | |
Not working | 3 (8) | 15 (46) | 18 (26) | |
Other | 6 (17) | 3 (9) | 9 (13) | |
Affective disorders (F30-F34) | 27 (75) | 31 (94) | 58 (84) | |
Anxiety disorders (F40-F41) | 21 (58) | 26 (79) | 47 (68) | |
Personality disorders (F60-F69) | 12 (33) | 14 (42) | 26 (38) | |
Depersonalization-derealization disorder (F48.1)e | 4 (11) | 11 (33) | 15 (22) | |
Somatoform (F45) | 3 (8) | 3 (9) | 6 (9) | |
Others (including F1x; F42; F50) | 18 (50) | 14 (42) | 32 (46) | |
Yes | 13 (36) | 12 (39) | 25 (37) | |
No | 23 (64) | 18 (58) | 41 (61) |
aIG: intervention group.
bWLCG: wait-list control group.
cWith the exception of gender, data on 2 persons missing.
dMultiple diagnoses; International Statistical Classification of Diseases (ICD-10) codes in parenthesis.
eSignificant difference between groups; χ21=4.7,
Descriptive statistics of outcome criteria at baseline and at the end of the intervention: intervention group (total, completers) versus wait-list control group.
Outcomes | T0a | T1b | ||||
IGtotalc (n=36), |
IGcomp (n=13)e, |
WLCGtotalf (n=33), |
IGtotal (n=36), |
IGcomp (n=13), mean (SD) | WLCGtotal (n=33), |
|
Emotion Regulation Skills Questionnaire (ERSQ) | 61.75 (17.13) | 66.85 (8.58) | 60.09 (15.22) | 63.84 (18.24) | 69.92 (13.85) | 56.24 (15.60) |
Patient Health Questionnaire 9 (PHQ-9) | 11.92 (5.46) | 10.08 (4.92) | 12.06 (5.7) | 11.06 (6.49) | 7.23 (3.92) | 13.15 (5.89) |
Generalized Anxiety Disorder |
10.53 (4.9) | 9.46 (5.17) | 10.61 (5.15) | 10.11 (5.42) | 7.23 (4.13) | 10.30 (5.25) |
European Health Interview Survey Quality of Life 8 (EUROHIS-QOL-8) | 2.04 (0.69) | 2.38 (0.47) | 1.98 (0.62) | 2.15 (0.88) | 2.65 (0.73) | 1.87 (0.66) |
Rosenberg Self-Esteem Scale (RSE) | 18.83 (7.31) | 22.46 (5.30) | 20.42 (6.45) | 17.08 (8.33) | 19.61 (7.02) | 17.39 (6.92) |
Somatic Symptom Scale (SSS-8) | 11.42 (5.54) | 8.92 (4.46) | 11.76 (6.65) | 11.06 (6.13) | 8.69 (5.28) | 12.64 (6.73) |
Cambridge Depersonalization Scale Short Version (CDS-2) | 1.47 (1.89) | 1.15 (1.46) | 2.76 (2.61) | 1.31 (1.69) | 0.69 (0.95) | 2.55 (2.39) |
Subjective prognosis of gainful |
1.36 (1.27) | 0.69 (1.03) | 1.15 (1.18) | 1.17 (1.21) | 0.46 (0.97) | 1.03 (1.10) |
aT0: Baseline.
bT1: End of intervention.
cIG: intervention group.
dSD: standard deviation.
eCompleters of the IG (10 weeks log-in and >50% of the units completed)
fWLCG: wait-list control group.
Test statistics: intention-to-treat (ITT) and completer analyses comparing intervention group (ITT, completers) and wait-list control group.
Outcomes | T0a | T1b | ||||||||
ITTc | Completer | ITT | Completer | |||||||
Emotion Regulation Skills Questionnaire (ERSQ) | 0.42 | .67 | 1.50 | .14 | 3.89 | .05 | 0.49 | 4.98 | .03 | 0.68 |
Patient Health Questionnaire-9 (PHQ-9) | 0.11 | .92 | 1.10 | .28 | 6.01 | .02 | 0.60 | 19.01 | <.001 | 1.33 |
Generalized Anxiety Disorder Assessment (GAD-7) | 0.07 | .95 | 0.68 | .50 | 0.02 | .88 | 0.00 | 4.09 | .049 | 0.62 |
European Health Interview Survey Quality of Life 8 (EUROHIS-QOL-8) | 0.38 | .70 | 2.12 | .04 | 4.63 | .04 | 0.53 | 7.35 | .01 | 0.83 |
Rosenberg Self-Esteem Scale (RSE) | 0.96 | .34 | 1.01 | .32 | 0.81 | .37 | 0.22 | 0.12 | .73 | 0.11 |
Somatic Symptom Scale (SSS-8) | 0.23 | .82 | 1.41 | .17 | 2.41 | .01 | 0.38 | 1.51 | .23 | 0.38 |
Cambridge Depersonalization Scale Short Version (CDS-2) | 2.33 | .02 | 2.63 | .01 | 0.70 | .41 | 0.21 | 2.03 | .08 | 0.55 |
Subjective prognosis of gainful employment (SPE) | 0.71 | .48 | 1.23 | .23 | 0.15 | .70 | 0.09 | 1.60 | .21 | 0.39 |
aT0: baseline;
bT1: End of intervention; analysis of covariance with
cITT: Intention-to-treat.
Web-based self-help interventions have proven effective in treating different kinds of mental disorders across a broad range of health contexts as single intervention as well as supplements to face-to-face treatments. However, although about half of face-to-face interventions in Germany have been psychodynamic, there has been little research on psychodynamic Web-based self-help. We have chosen affect-focused psychodynamic psychotherapy, which has proven an effective Web-based treatment for anxiety and depression [
In addition, our purpose was shifted from a single intervention to aftercare following inpatient or day clinic psychotherapy. Keeping these substantial differences to the previous trial in mind, our primary aim was to investigate the feasibility of our intervention.
Acceptance was good, that is, only 26.9% (31/115) of those attending the information session declined participation. Of those randomized to the IG, the great majority (86%, 36/42) logged into the program, and of these, 86% (31/36) completed the first unit (similar values were found for the WLCG. Satisfaction was rated highly at 95% (20/21). Due to the high proportion of missing data at the follow-up assessment, we additionally used the ratings for individual sessions completed, which still met our expectations of at least 75% satisfied, that is, rated as good (52%, 16/31) and very good (29%, 9/31). However, there was a steady decline of participation from unit 1 to unit 8; only 13/36 participants (36%) were actively participating throughout the entire program, completing at least 50% of the units. Similar to a trial by Gilbody et al [
However, results pointed to considerable benefit from participation in the program. According to the conservative estimates of ITT analysis with LOCF, participants improved significantly and with moderate effect sizes compared with the WLCG with improvements in depression, quality of life, and emotional competence (trend). Effects of the small number of completers were considerably stronger. In line with previous findings [
Although we had proposed that Web-based self-help may fill a gap between inpatient treatment and aftercare, we had not anticipated that 82% (18/22) in the IG and 68% (18/27) in the WLCG continued previous psychotherapy or started a new face-to-face treatment during our trial. We cannot be sure whether continuing or starting psychotherapy may have further discouraged participation in the Web-based self-help program because of additional time demands, and we cannot tell whether psychotherapists were informed of program participation by their patients and whether they were encouraging or discouraging toward participation by their patients.
There was a striking discrepancy between overall program satisfaction and benefit and the low rate of completion of the program, which we had not anticipated. This stands in contrast to the previous trial by Johansson et al [
A strength of this study was that we applied it in a clinical setting, recruiting patients from mental health care treatment. However, following intensive inpatient psychotherapy, our effect sizes can be expected to be smaller compared with trials when patients are recruited for primary Web-based treatment. Our findings alert us to the significance of the context of additional mental health treatments. An ongoing psychotherapy may have further diminished motivation and time for Web-based treatment, which was present in a substantial part of our IG but almost absent in the Swedish group. Although both groups resembled each other in terms of age, gender, and education, unlike the Swedish participants, our patient group was predominantly single and a high percentage was not working. From our clinical point of view, we would see this as being indicative of a chronically sick sample, with a considerable comorbidity of personality disorders, whose difficulties in life adjustment may have well impeded the ability to follow through a Web-based program that requires substantial self-directed effort.
As this was a feasibility study, the sample was small, particularly in the completer group. Therefore, we cannot differentiate compliance and success between subgroups (eg, the presence or absence of personality disorder, the structure of work, or outpatient psychotherapy).
Unfortunately, it is also not possible to compare the effects at the end of the intervention between the IG and the WLCG because participants of the WLCG only got access to the intervention after a waiting period of 10 weeks.
Our findings point to the requirement to target the intervention more specifically to the needs and capabilities of participants and the context of traditional mental health care. Although participants were satisfied with our intervention and gained significant benefits, the majority was not willing or able to follow it through to completion. To reduce the considerable weekly time demands, we have increased flexibility of participation differentiating between the required and optional exercises and extended the time allotted. To increase familiarity and compliance under less challenging conditions, we plan to offer participation to future patients routinely during inpatient treatment—given positive experiences in a recent trial combining deprexis24 with inpatient psychotherapy [
Screenshot of the Home page.
Screenshot of unit 2 of the intervention.
Screenshot of task 1 from unit 2 of the intervention.
CONSORT EHEALTH form V1.6.
analysis of covariance
analysis of variance
Cambridge Depersonalization Scale
Client Satisfaction Questionnaire
Emotion Regulation Skills Questionnaire
European Health Interview Survey Quality of Life 8-item index
General Anxiety Disorder Screener
intervention group
intention-to-treat
last observation carried forward
Patient Health Questionnaire
randomized controlled trial
Rosenberg Self-Esteem Scale
Subjective prognosis of gainful employment scale
Somatic Symptom Scale
wait-list control group
We would like to thank all our participating patients and the staff in the wards of the Department of Psychosomatic Medicine and Psychotherapy for their support in recruitment. The study was part of the doctoral thesis of Jan Becker. The trial was conducted by a member of a junior researcher work group. The work group was funded by the Illa und Werner Zarnekow-Stiftung. The funding body has no influence on the trial whatsoever.
RJF is the author of the book used as a basis for the treatment manual. All other authors declare that they have no conflicts of interest.