Long-term Effects of an Online Intervention Targeting Depression and Reward Sensitivity - Predictors and Mechanisms of Treatment Success
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Amount of social encounters reported during intervention exercises
研究概览
简要总结
See: ClinicalTrials.gov ID: NCT05402150
Relevant for this Paper:
This investigation aims to evaluate the stability of the effectiveness of different two-week online interventions in a four months follow-up regarding reward sensitivity, anhedonia and depression.
The authors will further investigate factors influencing treatment success regarding reward sensitivity. The investigators assume that the more depressive expectations and stress improve during our online intervention, the more change in reward insensitivity is experienced at follow-up. In addition, it is hypothesized that the more people engaged in physical activities and social encounters during the two-week online intervention, the more change in reward insensitivity is experienced at follow-up.
详细描述
See for main study: ClinicalTrials.gov ID: NCT05402150.
A possible maintaining role in depressive symptoms plays reward hyposensitivity. Therefore, treatments should include evidence-based psychological interventions that target and modify reward insensitivity. Prior research lacks studies investigating reward sensitivity as main outcome measure, especially in the web-based format. This is why this study investigated an online intervention with the following groups regarding effectively increasing reward sensitivity compared to a waitlist control condition:
a) mindfulness-based interventions, b) behavioral activation, c) a combination of both.
The daily exercises were supported via videos and worksheets. Here, the investigators explore the effects after a four-months follow-up. In addition, this paper will deal with the long-term prediction of reward sensitivity, a feature not considered in our main paper preregistered with the ID NCT05402150. Factors, which are considered to play a big role in reward sensitivity are perceived stress, depressive expectations, physical activity and the frequency of social encounters.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or above
- •Fluent in German
- •Informed consent
- •Depressive symptoms (PHQ-9 > 5)
排除标准
- •suicidality, severe depression
- •current or lifetime: substance use disorder, psychotic disorders, bipolar I or II
- •current psychotherapy
- •if antidepressant medication: has not been stable over the last 4 weeks
结局指标
主要结局
Amount of social encounters reported during intervention exercises
时间窗: during intervention
- Type of activities and reflected pleasant situations that have been selected in the daily online surveys
Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
时间窗: baseline, post intervention (after 2 weeks), 4 months follow-up
* Items range from 0 to 3 (0 = not at all; 1 = several days; 2 = more than a week; 3 = nearly every day). * PHQ-9 total score ranges from 0 to 27 (classification of scores: 5-9 mild depression; 10-14 as moderate depression; 15-19: moderately severe depression; 20 - 27 severe depression). * Consequently, a higher score means worse depressive symptoms.
Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)
时间窗: baseline, post intervention (after 2 weeks), 4 months follow-up
* Items range from "Definitely Agree", "Agree", "Disagree", and "Strongly Disagree". Either of the "Disagree responses" receive a score of 1 and either of the "Agree responses" receive a score of 0. * SHAPS-D total score ranges from 0 to 14. * Consequently, a higher score means a greater state anhedonia.
Change in Depressive Expectations (Depressive Expectations Scale, DES)
时间窗: baseline, post intervention (after 2 weeks), 4 months follow-up
* Items range from 1 to 5 (1 = I disagree , 2 = I partially disagree, 3 = neutral, 4 = I partially agree, 5 = I agree). * DES total score ranges from 25 to 125 * Consequently, a higher score means more dysfunctional depressive expectations.
Amount of physical activity reported during intervention exercises
时间窗: during intervention
- Type of activities and reflected pleasant situations that have been selected in the daily online surveys
Reward sensitivity (Positive Valence System Scale-21, PVSS-21)
时间窗: baseline, post intervention (after 2 weeks), 4 months follow-up
* Items range from 1 to 9 (1 = extremely untrue of me, 2 = very untrue of me, 3 = moderately untrue of me, 4 = slightly untrue of me, 5 = neutral, 6 = slightly true of me, 7 = moderately true of me, 8 = very true of me, 9 = extremely true of me). * PVSS-21 total score ranges from 21 to 189. * Consequently, a higher score means a higher reward responding.
Change in Stress level (Perceived-Stress-Scale 10, PSS-10)
时间窗: baseline, post intervention (after 2 weeks), 4 months follow-up
* Items range from 1 to 5 (1= never, 2 = almost never, 3 = sometimes, 4 = fairly often, 5 = very often) Items 4, 5, 7 and 8 are reverse scored for the total score. * PH=perceived helplessness subscale; PSE=perceived self-efficacy subscale * PH subscale is computed by summing up Items 1, 2, 3, 6, 9 and 10; the PSE subscale is computed by summing up items 4, 5, 7 and 8 * PSS-10 total score is the sum of all PH and reversed PSE items * Consequently, a higher score means a greater level of stress.
次要结局
- Adherence(post intervention (after 2 weeks), 4 months follow-up)
- Personality traits (Big Five Inventory 10, BFI-10)(Baseline, post intervention (after 2 weeks), four months follow-up])
- Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)(Baseline, post intervention (after 2 weeks), 4 months follow-up)
- Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)(Baseline)
- Trait reward responsiveness (Reward Responsiveness Scale, RRS)(Baseline, post intervention (after 2 weeks), 4 months follow-up)