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临床试验/NCT05771636
NCT05771636招募中不适用

Can Mental Imagery Increase Behavioral Activation ?

University of Liege2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
LOT

研究概览

简要总结

This study aims to investigate the effects of mental imagery practice on depression, behavioral activation, psychological well-being and other processes involved in depression such as anhedonia.

We use a multiple baseline design in addition to a pre-post and follow-up standardized assessment design.

详细描述

The purpose of this study is to determine if daily practice of mental imagery improves psychological variables such as motivation, behavioral activation, depression, mood, optimism, anhedonia, and psychological well-being, and if it's combination with activity planning is more effective than activity planning alone. This study will analyze the effect of 2 mental imagery conditions (planned activity imagery, best possible self) and a control condition of activity planning alone, administered to a general population over a 2-week period.

Our hypotheses are an improvement for both experimental conditions (planned activities imagery and best possible self imagery) of mood, behavioral activation, depressive symptomatology, optimism, psychological well-being, cognitive and behavioral avoidance, and anhedonia, compared to the control condition. Several studies have been able to show the effect of either imagery condition on certain variables (notably behavioral activation and mood for the planned activity imagery as well as optimism and mood for the best possible self), but the interest of our study is to assess the effect of each of the proposed protocols on a broader range of variables. This will allow us to determine the specific effect of each protocol as well as to compare their effectiveness.

In this study we will recruit 120 participants, randomly assigned to one of three conditions: (1) mental imagery of planned activities, (2) mental imagery of best possible self, (3) planned activity control group. All participants will be asked to complete a series of standardized assessments in 4 steps (at the first meeting, at the second meeting 15 days later, and a follow-up at 1 and 3 months post-intervention). The questionnaires will assess depression, behavioral activation, mood, optimism, imagery skills, anhedonia, and psychological well-being.

In each group, participants will have to think about 4 activities to be implemented within the next two weeks, and answer about 10 questions about the chosen activities (rated from 0 to 10 on a visual analogical scale). These questions evaluate, among other things, the motivation, the anticipated effort, the anticipated pleasure, and the degree of avoidance related to each activity using a visual analog scale. This questionnaire will be completed at the first meeting and also after the completion of each activity, at home. The protocol is identical for each condition except for the content of the imagery exercise or no imagery exercise for the control condition. The participants in the experimental conditions will be instructed to repeat the 5-minute imagery exercise at home every day for 2 weeks and report in a booklet everyday their rating of the imagery exercise (vividness, difficulty and their mood after the exercise).

At a second meeting 2 weeks later, all participants will be asked to complete the standardized assessments again and report whether or not the planned activities were completed, as well as conduct a semi-structured interview about their experience, the feasibility and difficulty of the task. Participants will then receive a follow-up survey by e-mail at 1 and 3 months post-intervention, in which they will again be asked to complete the selected standardized questionnaires. The booklets in which they reported the questionnaires about their planned activities (all conditions) and the ratings of imagery exercise (for experimental conditions) will be brought back on that meeting.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least some symptoms of depression (minimal score of 8 on the depression subscale of the HADS)

排除标准

  • Not ongoing psychotherapy at the time of the study

结局指标

主要结局

LOT

时间窗: 3 months after end of treatment

The Life Orientation Test (Revised) is a 10-items scale assesses one's dispositional level of optimism, providing meaningful insight into possible interventions, such as those to address harmful thought patterns. Scores can range from 0 to 24, being 0-13 Low Optimism, 14-18 Moderate Optimism, 19-24 High Optimism.

Mental Imagery ability

时间窗: 3 months after end of treatment

The Plymouth Sensory Imagery questionnaire is a 35 items scale measuring the vividness of mental imagery in seven different modalities: vision, sound, smell, taste, touch, bodily sensation, and emotion. There is a sub-score for every modality, with score ranging from 5 to 50 (better outcome) and a total score ranging from 35 to 350 (better outcome) higher score indicating higher imagery ability.

Depressive symptomatology

时间窗: 3 months after end of treatment

The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks. The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).

Well-being

时间窗: 3 months after end of treatment

The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).

Behavioral activation

时间窗: 3 months after end of treatment

The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)

PANAS

时间窗: 3 months after end of treatment

The Positive affect negative affect scale consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).

Anhedonia

时间窗: 3 months after end of treatment

The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).

次要结局

  • self concordant motivation(Baseline)
  • Anticipated satisfaction resulting in the activity(Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Importance of the activity(Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Difficulty to find time to do the activity(Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Vividness of the mental imagery exercise(Everyday at home during the two weeks intervention period, right after doing the imagery exercise (reporting in the booklet, at home))
  • Anticipated difficulty to do the activity(Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Perceived mood after doing the activity(Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Avoidance of the activity(Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Motivation to do this activity(Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Positive anticipation of the activity(Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Anticipated pleasure resulting in the activity(Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Anticipated Gratification resulting in the activity(Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Perceived difficulty after doing the activity(Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Perceived satisfaction after doing the activity(Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Perceived pleasure after doing the activity(Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Perceived gratification after doing the activity(Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home))
  • Difficulty of the mental imagery exercise(Everyday at home during the two weeks intervention period, right after doing the imagery exercise (reporting in the booklet, at home))
  • Mood after doing the mental imagery exercise(Everyday at home during the two weeks intervention period, right after doing the imagery exercise (reporting in the booklet, at home))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ecaterina Lazari

Principal Investigator

University of Liege

研究点 (2)

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