Is Less More? Dosing and Sequencing Effects of Cognitive Therapies for Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Depressive symptoms
研究概览
简要总结
The investigators want to evaluate core components from cognitive behavioral psychotherapies (CBTs) with the aim of investigating dosing and combinatory effects on conditions of anxiety and depression.
详细描述
In the present study, participants will be randomly assigned to one of four groups, receiving one or both treatment components under investigation, all over the course of six sessions of treatment.
- It is hypothesized that both component A (Cognitive Restructuring) and component B (External Attention Allocation) will be efficient in reducing symptoms of depression and anxiety when delivered separately, both when delivered over 3 and 6 sessions. The difference between components as well as between the number of sessions on primary and secondary outcomes will be explored.
- The combinatory effects, comparing the effect of receiving Component A subsequent to Component B and vice versa will be explored.
- The process of change in both components will be explored.
- Group differences in participants' experience of being the recipient of the components (either individually or combination) both qualitatively (free descriptions of their experience with using them) and quantitatively (questionnaires concerning the understanding and employment) will be explored.
- The moderating effect of baseline characteristics including baseline symptomatology, diagnoses, personality functioning, and working alliance will be explored.
- Potential harmful effects will be explored in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be unaware both of the planned component comparisons and of the study hypotheses.
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
- •(i) age ≥ 18 years, (ii) Clinically relevant symptoms of an anxiety disorder (with the exception of specific phobia) and/or depressive disorder according to GAD-7≥10, SIAS ≥37, PHQ-9 ≥10, or PDSS ≥9, (iii) Danish language proficiency, (iv) ability and willingness to give informed consent, (v) no or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 6 weeks), (vi) access to either a smartphone, tablet, or computer with video camera.
排除标准
- •(i) severe depression deemed to require more intense psychotherapy or medication (PHQ-9-score of 20 or more combined with a clinical evaluation), (ii) currently receiving other psychotherapy or counseling, (iii) a history of bipolar disorder, (iv) current or past psychotic episode, (v) substance abuse or dependence judged to require treatment, (vi) suicide risk requiring immediate hospitalization.
研究组 & 干预措施
Cognitive restructuring (CR)
6 sessions of CR drawn from classic Cognitive Behavioral Therapy (CBT)
干预措施: Cognitive restructuring (Behavioral)
Attention allocation (AA)
6 sessions of AA building on contemporary CBTs
干预措施: Attention allocation (Behavioral)
CR followed by AA
3 sessions of CR followed by 3 sessions of AA
干预措施: Cognitive restructuring (Behavioral)
CR followed by AA
3 sessions of CR followed by 3 sessions of AA
干预措施: Attention allocation (Behavioral)
AA followed by CR
3 sessions of AA followed by 3 sessions of CR
干预措施: Cognitive restructuring (Behavioral)
AA followed by CR
3 sessions of AA followed by 3 sessions of CR
干预措施: Attention allocation (Behavioral)
结局指标
主要结局
Depressive symptoms
时间窗: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.
Patient Health Questionnaire-9 (Kroenke et al., 2001; Spitzer et al., 1999; Spitzer et al., 2000; PHQ-9). 9 items are rated on a scale from 0 to 3, with a potential total range from 0 to 27. Larger scores mean more depressive symptoms (i.e., a negative outcome).
Anxiety symptoms
时间窗: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.
Beck's Anxiety Inventory (Beck et al., 1988; Beck \& Steer, 1991; BAI). 21 items are rated on a scale from 0 to 3 with a total score thus ranging from 0 to 63. A higher score is indicative of more anxiety symptoms (i.e., a negative outcome).
次要结局
- Depressive symptoms(Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.)
- Anxiety symptoms(Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.)
- Symptoms of generalized anxiety disorder(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.)
- Symptoms of panic disorder(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.)
- Symptoms of social anxiety disorder(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.)
- Worry(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.)
- Decentering(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.)
- Cognitive change(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.)
- Cognitive reappraisal(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.)
- Mindfulness(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.)
- Attention control(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.)
- Valued Living(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.)
- Quality of life (well-being)(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.)
- Personality functioning(Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.)
- Harm/negative effects(Measured only one time, that is, post treatment (just after the 6 sessions).)
- Information overload(Measured only one time, that is, post treatment (just after the 6 sessions).)