A Blended Intervention for Adjustment Disorder: Feasibility Trial and Preliminary Effectiveness.
概览
- 阶段
- 不适用
- 干预措施
- • Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference.
- 疾病 / 适应症
- Adjustment Disorders
- 发起方
- Universitat Jaume I
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Participants' adherence to the intervention.
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
The aim of this study is to evaluate the feasibility (including usability and satisfaction) and preliminary effectiveness of a blended intervention for Adjustment Disorder. This intervention combines a self-applied Internet-based program (TAO) with face-to-face sessions with a therapist via videoconference.
详细描述
Adjustment disorder (AjD) is one of the most commonly diagnosed disorders in clinical practice. However, although there is still no evidence-based treatment for this problem, Cognitive Behavioral Therapy (CBT) is the most studied. Internet-based treatments emerge as an alternative to reach more people in need while reducing intervention costs. However, high drop-out rates in this format highlight the need to develop new ways of delivering treatments. The present study aims to test a blended treatment for AjD that combines a self-applied CBT programme online (TAO: Adjustment Disorder Online) with face-to-face sessions with a therapist via videoconference every 10-12 days. Only one treatment group has been included and patients will be evaluated at pre-treatment, post-treatment and follow-up (3 and 12 months). The study will be conducted following the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement for pilot and feasibility studies (Eldridge et al., 2016), the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and online TeleHealth guidelines (Eysenbach, 2011), and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (Chan et al., 2013a; 2013b). Specific objectives of the study include: (1) To analyse the feasibility of different recruitment and data collection methods (e.g., how broad or restrictive are the eligibility criteria, how willing are patients to participate, time needed to collect data), (2) To explore reasons for non-participation and drop-outs from treatment, (3) To assess patient satisfaction and acceptance of treatment (both quantitatively and qualitatively), (4) In addition, as a secondary objective to explore the potential effectiveness of the treatment at post-treatment and follow-up.
研究者
入排标准
入选标准
- •Age ≥ 18 years.
- •Meeting diagnostic criteria for Adjustment Disorder based on the International Classification of Diseases 11 edition (ICD-11).
- •Exceed the cut-off point of 47.5 on the Adjustment Disorder New Module-20 scale (ADNM-20; Lorenz et al., 2016).
- •Sign an informed consent.
- •Ability to understand and read Spanish.
- •Ability to use a computer and having access to the Internet.
- •Having an e-mail address.
排除标准
- •Presence of risk of suicide or self-destructive behaviors.
- •Presence of another severe mental disorder (substance abuse or dependence, psychotic disorder, dementia, bipolar disorder or personality disorder).
- •Receiving other psychological treatment during the study for AjD.
- •An increase and/or change in the medication during the study period.
研究组 & 干预措施
Blended intervention for AjD.
Blended intervention for AjD. Main components: psychoeducation, techniques for regulating emotions, exposure, problem-solving techniques, Mindfulness, acceptance and elaboration of the stressful event, positive psychology strategies and relapse prevention.
干预措施: • Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference.
结局指标
主要结局
Participants' adherence to the intervention.
时间窗: At post-treatment (approximately 12 weeks from the beginning).
Drop-outs rates (and reasons), number of modules completed, number of times participants enter treatment, time spent in treatment and whether they do reviews.
Opinion Questionnaire about the intervention
时间窗: At post-treatment (approximately 12 weeks from the beginning).
It assesses participants' opinion about TAO online program, the videoconference sessions with the therapist and the blended format. The questions refer to the satisfaction and usefulness of these components using a response scale from 0 to 10 and open-ended opinion questions.
Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).
时间窗: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
This questionnaire consists of two different scales. Both include 6 items with a response scale ranging from 0 (not at all) to 10 (completely). One of the scales refers to the expectations about the treatment and it is administered before starting the treatment once an explanation about it has been carried out. The other scale refers to the patients' opinion once they have finished the intervention.
Usability System Scale (SUS; Bangor et al., 2008; Brooke,1996).
时间窗: At post-treatment (approximately 12 weeks from the beginning).
This scale assesses the usability of a service or product and the acceptance by the users. It consists of 10 items with a response scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Working Alliance Inventory for guided Internet Interventions (WAI-I) adapted from Horvath and Greenberg (1989).
时间窗: At post-treatment (approximately 12 weeks from the beginning).
The WAI-I scale assesses the different components of therapeutic alliance according to Bordin (1979). This version is adapted for internet-based treatments and consists of 12 items with a response scale from 1 (never) to 7 (always).
次要结局
- Change in the Loss and Stress Inventory (IEP) (Quero et al., 2019).(At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).)
- Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Norman et al., 2006; González-Robles et al., 2018).(At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).)
- Change in Adjustment Disorder New Module-20 (ADNM-20; Einsle et al., 2010).(At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).)
- Change in the Positive and Negative Affect Scale (PANAS trait) (Watson et al., 1988; Díaz-García et al., 2020).(At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).)
- Change in the Posttraumatic Growth Inventory (PTGI) (Tadeschi and Calhoun,1996; Weiss et al., 2006).(At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).)
- Change in the Overall Depression Severity and Impairment Scale (ODSIS; Norman et al., 2006; Mira et al., 2019).(At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).)