NCT05771636

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

2.2 years

First QC Date

March 1, 2023

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (28)

  • 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

  • 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)

  • 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

  • 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

  • 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

  • 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)

  • 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

  • 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

  • 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

  • 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)

  • 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

  • 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

  • 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

  • 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)

  • 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

  • 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

  • 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

  • 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)

  • 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

  • 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

  • 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

  • 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)

  • 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

  • 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

  • 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

  • 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)

  • 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

  • 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 Outcomes (27)

  • self concordant motivation

    Baseline

  • Motivation to do this activity

    Baseline

  • 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

    Baseline

  • Positive anticipation of the activity

    Right before doing the activity (during the two weeks intervention, reporting in the booklet, at home)

  • +22 more secondary outcomes

Study Arms (3)

Experimental G1 - imagery of planned activity

EXPERIMENTAL

In this condition, the participant will have to think about 4 activities he will plan to do during the next 2 weeks. He will then complete a questionnaire about all the activities he identified and think about the major obstacle that could prevent him to do each activity, and a solution for each one. Then he will proceed to a mental imagery exercise where he imagines doing the activity as vividly as possible. He then will proceed to go home and repeat the imagery practice every day for the next two weeks, and do the planned activities. He will report in a booklet ratings of the mental imagery exercise and the activities he did.

Behavioral: Mental Imagery

Experimental G2 - imagery of best possible self

EXPERIMENTAL

In this condition, the participant will first have to do a mental imagery exercise where he imagines his best possible self, having accomplished all his big life goals, as vividly as possible. He will then have to think about 4 activities he will plan to do during the next 2 weeks, in line with the imagery exercise. He will then complete a questionnaire about all the activities he identified. He then will proceed to go home and repeat the imagery practice every day for the next two weeks, and do the planned activities. He will report in a booklet ratings of the mental imagery exercise and the activities he did.

Behavioral: Mental Imagery

Control G3 - activity planification alone

ACTIVE COMPARATOR

In this condition, the participant will have to think about 4 activities he will plan to do during the next 2 weeks. He will then complete a questionnaire about all the activities he identified. There is no mental imagery exercise in this condition. He then will proceed to go home and receive the assignment to do the planned activities in the course of the next two weeks. He will report in a booklet ratings of the activities he did.

Behavioral: Control condition (activity planification)

Interventions

Mental ImageryBEHAVIORAL

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.

Experimental G1 - imagery of planned activityExperimental G2 - imagery of best possible self

The participant identifies 4 activities that he plans to do in the course of the next 2 weeks.

Control G3 - activity planification alone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not ongoing psychotherapy at the time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

DepressionAnhedonia

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ecaterina Lazari, master degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 16, 2023

Study Start

March 1, 2023

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations