Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial

This multicenter study is coordinated by the outpatient clinic for behavioral addictions of the Clinic for Psychosomatic Medicine and Psychotherapy of the University Medical Center Mainz. Three centers will further participate, the Anton-Proksch-Institute, Austria, the Section Addiction Medicine and Addiction Research of the University Hospital Tübingen, and the Addiction Medicine of the Central Institute of Mental Health in Mannheim.

Investigators in all centers are psychotherapists (physicians or psychologists) and experts in the treatment of addiction behavior.

Patients will be included, if the following eight inclusion criteria are fulfilled: (1) IA/CA according to the AICA (Assessment of Internet and Computer game Addiction) expert rating for at least 6 months and (2) a score ≥ 7 in the AICA self-report IA/CA. (3) Patients with co-morbid disorders will be included, provided that IA/CA is the primary diagnosis. The study will only include (4) men in (5) the age between 17 and 45 years. (6) If the patients are currently on psychotropic medications, no changes in medications and dosages in the past 2 months and during STICA treatment are allowed. (7) If currently off all psychotropic medications, patient must have been off at least 4 weeks. (8) During STICA no other ongoing psychotherapy is allowed and previous psychotherapy must have been completed for at least 4 weeks.

Patients with a score <40 in the Global Assessment of Functioning (GAF [28]) or severe major depression (Beck Depression Inventory; BDI-II [29] ≥ 29) are excluded. Additional exclusion criteria are current alcohol or drug addictions, borderline, antisocial, schizoid, and schizotypal personality disorders, a lifetime diagnosis of schizophrenia, schizoaffective, bipolar, or organic mental disorder and a current unstable medical illness.

Over a time period of 36 months we plan to include 192 patients in the study. The patients will be randomly assigned to the intervention or to the wait list control group (WLC). Prior to randomization, a total of 18 patients have to be allocated to the trial. The intervention group will start treatment immediately after randomization, whereas the WLC group has to wait over a period of 4 months, until they will receive the same therapy.

The manualized STICA [26] is based on a cognitive behavior approach and combines group with individual therapy. STICA comprises 23 psychotherapy sessions with a total duration of 4 months. Fifteen out of twenty-three sessions will be weekly group sessions (100 min each) and eight will be fortnightly individual sessions (50 min).

Table 1 shows treatment phases and strategies during the early, middle, and termination phases. Based on understanding the mechanisms and the consequences of IA/CA (early phase), patients are trained to identify the triggers of their own dysfunctional internet use. By using diaries, social skill training, and exposition training, patients learn to reduce and to control their computer and internet use. In the termination phase of treatment, tools will be transferred to daily life and strategies for relapse prevention will be discussed.

Figure 1 shows a flow chart of the five time points of assessment. At T0a patients are informed about the study and assessed for eligibility. Patients fill out the AICA-S [30, 31], Müller KW, Glaesmer H, Brähler E, Wölfling K, Beutel M; Internet addiction in the general population. Results from a german population-based survey. unpublished] and the BDI-II [29]. AICA-S values range between 0 and 27, and scores ≥ 7 have been defined as problematic internet use. Therapists assess onset, course, and criteria of IA/CA, treatment history, motivation for therapy, and the GAF [28]. The AICA Checklist will be rated by an independent and blinded rater.

The assessment T0b is performed immediately before randomization and commencement of treatment. The criteria for IA/CA will be rechecked by self-report measurements, if the delay due to the group recruitment exceeds 2 weeks. Therapists fill out the GAF [28] and collect information about medications, other therapies, and treatment history. An independent and blinded rater will assess mental disorders with the SCID-I/II [32] and conduct the AICA-Checklist. A drug screening is further used to assess objective information on drug consumption. Self-report assessment includes IA/CA (AICA-S [30, 31]), depression (BDI-II [29]), obsessive-compulsive behavior (SCL-90-R [33]), generalized anxiety and panic (Patient Health Questionnaire [34]), somatization [34], general distress [34], depersonalization (CDS-2 [35]), and social fear (LSAS [36]). Patients also fill out dimensions of personality (NEO-FFI [37]), attention deficit disorder (WURS-k [38]), self-efficacy (SWE [39, 40]), positive and negative affectivity (PANAS [41]), and adverse childhood experiences (ACE [42]). Finally, they answer questions concerning perceived stress (PSS [43]) and about their life satisfaction (FLZ [44]). Attention of the patients will be checked with the d2 [45].

After 2 months of therapy (T1) patient-rated outcome measures are reapplied (AICA, GAF, BDI-II) and drug screening repeated. The outcome measures are supplemented by assessments of group climate (GCQ [46]) and therapeutic alliance (HAQ [47]).

Immediately after completion of the intervention (T2) patients fill out a set of questionnaires identical with the set at T0b, except for the trait measures (NEO-FFI, WURS-k, ACE). Group climate and therapeutic alliance are assessed additionally. Drug screening is applied and is obligatory. For patients of the WLC group this is the final assessment. Shortly after the survey their intervention will start.

Patients of the intervention group are asked to evaluate the stability of treatment effects 6 months after termination of treatment (T3). Thereby the used set of questions corresponds to T2.

In this study there are two sources of electronic study data. An eCRF has been developed for the investigators to document their study data in a database stored, maintained, and administered by the IZKS Mainz. It is password protected with individual accounts for all investigators.

Patients will answer the self-report questionnaires by entry forms customized for iPADs. Each patient receives only access to his own current questionnaire.

After data collection, eCRF and iPAD data will be transformed into one SAS database for evaluation.

The purposes or this study are to determine the efficacy of STICA, to assess the durability of treatment response in these patients, and the impact on associated mental symptoms (for example social anxiety and depression).

The primary efficacy endpoint is defined as improvement of IA/CA rated by the patient himself (primary outcome measure: AICA-S [30, 31]). At the end of therapy an AICA-S score <7 indicates remission.

Secondary endpoints include the remission of IA/CA in the expert rating (AICA-C ≤ 13). The preoccupation with the internet or computer games will be analyzed (hours spent per week). IA and CA are associated with negative consequences in health, social communication, psychosocial wellbeing (GAF [28], BDI-II [30], LSAS [36]), level of performance in school or work, and self-efficacy (SWE [39]). For each instrument assessments at baseline will be compared to assessments obtained 4 and 6 months after therapy.

Patients will be randomly assigned either to the STICA intervention group or to the WLC group. The randomization list will be generated stratified by the Interdisciplinary Centre for Clinical Trials (IZKS). Considering the average therapy group size of eight patients, 16 patients have to be randomized at the same time. The randomization ratio will be 1:1 within each center. After confirmation that a patient fulfils all inclusion criteria for randomization, the electronic case report form (eCRF) will immediately provide the investigator with the randomization results. Patients are subsequently informed about the randomization result and the intervention starts shortly after randomization. The IZKS will furthermore insure treatment integrity by regular site visits.

Safety parameters will comprise newly occurring psychiatric diagnoses (SCID-I [32]) and all serious adverse events that are reported during and up to 6 months after treatment. Therefore in the context of psychotherapy suicidal ideations or the global functioning level will be regarded.

According to GCP, an adverse event (AE) is defined as follows: any untoward medical occurrence in a patient participating in a clinical trial. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, whether or not related to the trial intervention. Due to the fact that this trial analyses a psychological treatment, only AEs concerning psychological conditions, defined as any disorder classified by the International Classification of Diseases [48] F00-F99 (‘Mental and Behavioral Disorders’) will be documented.

For this study the following conditions were defined as AE: (1) new symptoms/medical conditions, (2) new diagnosis, (3) intercurrent diseases and accidents, (4) worsening of medical conditions/diseases existing before clinical trial start, (5) recurrence of disease, or (6) increase of frequency or intensity of episodical diseases.

A serious adverse event (SAE) is an AE that: (1) results in death, (2) is life-threatening, (3) requires patient hospitalization or prolongation of existing hospitalization, (4) results in persistent or significant disability/incapacity, or (5) is a congenital anomaly/birth defect.

All medical complications during the study are documented in the eCRF.

Clinical protocol and written informed consent were approved by the Ethics Committee (EC) of the Federal State of Rhineland Palatinate (Germany), which is responsible for the coordinating centre Mainz (Ref. No. 837.316.11 (7858)). Ethics Committees of all cooperating centers will provide the necessary additional documents.

All procedures described in the clinical trial protocol follow the ICH-GCP guidelines and the ethical principles described in the current revision of the Declaration of Helsinki. The trial will be carried out in keeping with local legal and regulatory requirements.

Before being admitted to the clinical trial, patients receive detailed explanations of the nature, scope, and possible consequences of the clinical trial in a form understandable to them. The patients must give consent in writing. Each patient will receive a copy of the signed informed consent document.

In this clinical trial all patients, including the WLC group will receive the full treatment. For the WLC patients the therapy begins after a waiting period of 4 months.

An independent Data Monitoring and Safety Board (DMSB) has been established for this study. The DMSB will supervise the conduct of this trial and will issue recommendations for early termination, modifications or continuation of the trial, if necessary. The DMSB and the EC must be informed immediately of study-related SAE.

The first patient was enrolled to the STICA study on February 1, 2012. Follow-up measures for the last included patients were expected to be terminated in June 2014.