Optimizing a Digital Ultra-brief Treatment for Patients Waiting for Face-to-face Psychotherapy: An Investigation of Treatment Content, Human Support, and Patient Expectations (OPTIBRIEF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Depression and anxiety symptom severity assessed by the PHQ-ADS
研究概览
简要总结
The OPTIBRIEF study investigates different versions of a digital ultra-brief intervention (UKADO - a German acronym for ultra-brief intervention against anxiety and depression online) during the waiting period for psychotherapy. Using a factorial trial design, the components 1) intervention content, 2) human support, and 3) expectation-fostering elements will be examined.
After completing initial questionnaires and participating in a diagnostic interview, participants are randomly assigned to one of eight groups and work through a specific version of UKADO. The program can be completed in a session of approximately 60 minutes, after which the exercises should continue to be used. Participants then complete another set of questionnaires at specific time points (after 2 weeks, 5 weeks, 9 weeks, and 24 weeks). A selection of participants also takes part in another telephone appointment to assess experiences with UKADO.
With the OPTIBRIEF study, the investigators aim to determine which version of the program is most suitable for individuals waiting for a psychotherapy slot. To this end, the investigators examine the effects on anxiety and depression symptom severity, as well as aspects such as participants' experiences with the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants are assigned to 8 conditions. Due one factor being human support (on vs. off), that can reasonably be guessed, this is not considered full participant masking.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Read the patient information and return signed written informed consent sheet
- •Currently waiting for outpatient psychotherapy (self-report at baseline and assessed per telephone)
- •Age ≥ 18 (self-report at baseline and assessed per telephone)
- •Scoring equal to or above 10 on the PHQ-ADS (self-report at baseline)
- •Fulfilling diagnostic criteria of one or more of the following disorders assessed with the Diagnostic Short-Interview for Mental Disorders (Mini-DIPS, DSM-5 version; Margraf et al., 2017): Major Depressive Disorder, Persistent Depressive Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder
- •Sufficient German skills (self-report at baseline)
- •Access to the internet (self-report at baseline)
排除标准
- •Acute suicidality assessed during the telephone interview (Mini-DIPS)
- •Currently taking part in psychotherapy or a scheduled start of psychotherapy prior to the assessment 14 days post-randomization (assessed via self-report and during the DIPS telephone interview)
研究组 & 干预措施
Problem-focused content and expectation fostering elements
Problem-focused condition of UKADO without human support but with expectation fostering elements
干预措施: UKADO Content - problem-focused (Behavioral)
Problem-focused content and expectation fostering elements
Problem-focused condition of UKADO without human support but with expectation fostering elements
干预措施: Expectation fostering elements (Behavioral)
Problem-focused content and human support
Problem-focused condition of UKADO with human support but no expectation fostering elements
干预措施: UKADO Content - problem-focused (Behavioral)
Problem-focused content and human support
Problem-focused condition of UKADO with human support but no expectation fostering elements
干预措施: Human support (Behavioral)
Problem-focused content + human support + expectation fostering elements
Problem-focused condition of UKADO with human support and expectation fostering elements
干预措施: UKADO Content - problem-focused (Behavioral)
Problem-focused content + human support + expectation fostering elements
Problem-focused condition of UKADO with human support and expectation fostering elements
干预措施: Human support (Behavioral)
Problem-focused content + human support + expectation fostering elements
Problem-focused condition of UKADO with human support and expectation fostering elements
干预措施: Expectation fostering elements (Behavioral)
Resource-focused content
Resource-focused condition of UKADO without human support and without expectation fostering elements
干预措施: UKADO Content - resource-focused (Behavioral)
Resource-focused content and expectation fostering elements
Resource-focused condition of UKADO without human support but with expectation fostering elements
干预措施: UKADO Content - resource-focused (Behavioral)
Resource-focused content and expectation fostering elements
Resource-focused condition of UKADO without human support but with expectation fostering elements
干预措施: Expectation fostering elements (Behavioral)
Resource-focused content and human support
Resource-focused condition of UKADO with human support but without expectation fostering elements
干预措施: UKADO Content - resource-focused (Behavioral)
Resource-focused content and human support
Resource-focused condition of UKADO with human support but without expectation fostering elements
干预措施: Human support (Behavioral)
Resource-focused content + human support + expectation fostering elements
Resource-focused condition of UKADO with human support and with expectation fostering elements
干预措施: UKADO Content - resource-focused (Behavioral)
Resource-focused content + human support + expectation fostering elements
Resource-focused condition of UKADO with human support and with expectation fostering elements
干预措施: Human support (Behavioral)
Resource-focused content + human support + expectation fostering elements
Resource-focused condition of UKADO with human support and with expectation fostering elements
干预措施: Expectation fostering elements (Behavioral)
Problem-focused content
Problem-focused condition of UKADO without human support or expectation fostering elements
干预措施: UKADO Content - problem-focused (Behavioral)
结局指标
主要结局
Depression and anxiety symptom severity assessed by the PHQ-ADS
时间窗: At two weeks
Self-reported depression and anxiety symptom severity will be measured using the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS; Kroenke et al., 2016; 2019). The PHQ-ADS combines the Patient Health Questionnaire 9-item depression scale (PHQ-9) and 7-item Generalized Anxiety Disorder scale (GAD-7). Scores range from 0 to 48, with higher scores indicating greater symptom severity. The primary endpoint is at 2 weeks. Assessments will also be conducted at baseline, 5 weeks, 9 weeks, and 24 weeks.
次要结局
- Negative effects(2 weeks, 5 weeks, 9 weeks, 24 weeks)
- Depression and anxiety symptom severity assessed by the PHQ-ADS(24 weeks)
- Therapeutic alliance(2 weeks, 5 weeks, 9 weeks)
- Treatment expectations(Baseline, two weeks, 5 weeks, 9 weeks)
- Depression symptom severity(Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks.)
- Anxiety symptom severity(Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks)
- Quality of life (EQ-5D-5L)(Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks)
- Satisfaction with treatment(two weeks)
- Resource activation and problem mastery(2 weeks, 5 weeks, 9 weeks)
- Depression and anxiety symptom severity assessed by the PHQ-ADS(5 weeks, 9 weeks)