Mental Imagery and Psychological Well-being

Depression Clinical Trial

Official title:

Can Mental Imagery Increase Behavioral Activation ?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771636
• Other study ID #: 1959-827
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: University of Liege
• Contact: Ecaterina Lazari, master degree
• Phone: +324/366.23.37
• Email: e.lazari[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not ongoing psychotherapy at the time of the study

Related Conditions & MeSH terms

• Anhedonia
• Depression

Intervention

Behavioral:
• Mental Imagery
Mental Imagery consists of imagining a situation in the most vivid way possible, including all sensory modalities (visual image, sensations, smells, sounds, emotions). It can be used to act as a motivational amplifier, by pre-experimenting a situation in imagination. The best possible self imagery consists of imagining the best version possible of one's self , after accomplishing all their major life goals, in a future where everything turned out the best way possible. What does this best version of you do, in terms of actions, on an everyday basis ? The planned imagery exercise consists of rehearsing an activity in a mental way, before actually doing it. It can help to visualize the outcome of this activity and benefits it can provide to the participant before actually getting it done.
• Control condition (activity planification)
The participant identifies 4 activities that he plans to do in the course of the next 2 weeks.

Locations

Country	Name	City	State
Belgium	Université de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptomatology	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).	Baseline
Primary	Depressive symptomatology	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).	Two weeks after beginning of treatment (end of treatment)
Primary	Depressive symptomatology	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).	1 month after end of treatment
Primary	Depressive symptomatology	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).	3 months after end of treatment
Primary	Behavioral activation	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)	Baseline
Primary	Behavioral activation	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)	Two weeks after beginning of treatment (end of treatment)
Primary	Behavioral activation	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)	1 month after end of treatment
Primary	Behavioral activation	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)	3 months after end of treatment
Primary	LOT	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.	Baseline
Primary	LOT	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.	Two weeks after beginning of treatment (end of treatment)
Primary	LOT	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.	1 month after end of treatment
Primary	LOT	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.	3 months after end of treatment
Primary	PANAS	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)	Baseline
Primary	PANAS	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)	Two weeks after beginning of treatment (end of treatment)
Primary	PANAS	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)	1 month after end of treatment
Primary	PANAS	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).	3 months after end of treatment
Primary	Anhedonia	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).	Baseline
Primary	Anhedonia	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).	Two weeks after beginning of treatment (end of treatment)
Primary	Anhedonia	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).	1 month after end of treatment
Primary	Anhedonia	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).	3 months after end of treatment
Primary	Well-being	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).	Baseline
Primary	Well-being	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).	Two weeks after beginning of treatment (end of treatment)
Primary	Well-being	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).	1 month after end of treatment
Primary	Well-being	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).	3 months after end of treatment
Primary	Mental Imagery ability	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.	Baseline
Primary	Mental Imagery ability	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.	Two weeks after beginning of treatment (end of treatment)
Primary	Mental Imagery ability	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.	1 month after end of treatment
Primary	Mental Imagery ability	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.	3 months after end of treatment
Secondary	self concordant motivation	The self concordance motivation scale is a scale in which the participant rates his motivation to pursue a goal based on 4 different reasons (external, introjected, identified and intrinsic) on a scale from 1 to 9, designed to measure if the motivation of a person relative to his goals is intrinsic or extrinsic.; The self-concordance variable is calculated by averaging the intrinsic and identified ratings and subtracting the average external and introjected ratings. A higher score means higher self-concordance (better outcome)	Baseline
Secondary	Motivation to do this activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Baseline
Secondary	Motivation to do this activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Positive anticipation of the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Baseline
Secondary	Positive anticipation of the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Anticipated pleasure resulting in the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Baseline
Secondary	Anticipated pleasure resulting in the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Anticipated satisfaction resulting in the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Baseline
Secondary	Anticipated satisfaction resulting in the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Anticipated Gratification resulting in the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Baseline
Secondary	Anticipated Gratification resulting in the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Anticipated difficulty to do the activity	Assessment on a scale from 0 (minimum, better outcome) to 10 (maximum, worse outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Baseline
Secondary	Anticipated difficulty to do the activity	Assessment on a scale from 0 (minimum, better outcome) to 10 (maximum, worse outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Avoidance of the activity	Assessment on a scale from 0 (minimum, better outcome) to 10 (maximum, worse outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Baseline
Secondary	Avoidance of the activity	Assessment on a scale from 0 (minimum, better outcome) to 10 (maximum, worse outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Importance of the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Baseline
Secondary	Importance of the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Difficulty to find time to do the activity	Assessment on a scale from 0 (minimum, better outcome) to 10 (maximum, worse outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Baseline
Secondary	Difficulty to find time to do the activity	Assessment on a scale from 0 (minimum, better outcome) to 10 (maximum, worse outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Perceived difficulty after doing the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Perceived mood after doing the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Perceived pleasure after doing the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Perceived satisfaction after doing the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Perceived gratification after doing the activity	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Right after doing the activity (during the two weeks intervention, reporting in the booklet, at home)
Secondary	Difficulty of the mental imagery exercise	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Everyday at home during the two weeks intervention period, right after doing the imagery exercise (reporting in the booklet, at home)
Secondary	Mood after doing the mental imagery exercise	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Everyday at home during the two weeks intervention period, right after doing the imagery exercise (reporting in the booklet, at home)
Secondary	Vividness of the mental imagery exercise	Assessment on a scale from 0 (minimum, worse outcome) to 10 (maximum, better outcome) of the effects and costs of this activity perceived by the participant. The question is asked for each identified activity.	Everyday at home during the two weeks intervention period, right after doing the imagery exercise (reporting in the booklet, at home)