Treatment for Rehabilitation of Action Cognition in Depression

Depression Clinical Trial

— T-RAC  

Official title:

Testing the Efficiency of a Psychological Treatment for the Rehabilitation of Action Cognition in Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625230
• Other study ID #: PN-III-P1-1.1-TE-2021-1090
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: November 2022
• Source: University of Oradea
• Contact: Alexandru Tiba, PhD
• Phone: +40 754 598 233
• Email: alexandrutiba[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present research study investigates the effects of a brief dynamic imagery intervention added to a short behavioral activation treatment on the treatment acceptability, feasibility, and primary efficacy for individuals with depression. Behavioral activation treatment is a standard treatment for depression. To enhance behavioral activation treatment acceptance and efficacy, a dynamic imagery intervention was added to augment the motor component of imagery and memories. Two types of treatment were compared: (1) behavioral activation treatment and (2) behavioral activation treatment plus dynamic imagery. The behavioral activation treatment is a short 8-session intervention based on a dynamic imagery procedure for enhancing the recruitment of motor activation in cognitive processing. 110 participants will be randomized into two groups. Half will be randomized to standard behavioral activation treatment and a half to behavioral activation treatment plus imagery treatment. Participants complete the assessment before, during (weekly), and after treatment. Follow-up will be measured at 3 months after the end of the treatment.

Description:

Major depressive disorder is a highly prevalent and chronic disorder incurring significant costs to society. Although several treatments are recommended for the treatment of major depressive disorder, the high rate of recurrence suggests the need for constant improvement in the treatments for depression. Cognitive deficits following depressive episodes are possible targets to improve existing treatments. Cognitive symptoms are residual symptoms and often interfere with the ability of individuals with depression to solve life problems. Building on the idea that action cognition and motor imagery deficits are more stable in depressed individuals a rehabilitation-type of motor imagery training was developed. It is based on principles of rehabilitation of motor imagery (used in sport as in the field of neurorehabilitation), for individuals with neurological conditions. It does integrate a forward modeling of action and motor imagery, remote kinematics (Kinect) and embodied cognition account. This new intervention proved efficient in clinical work. There are several steps to the intervention. In the first session, the therapist explains the intervention and teaches a dynamic simulation routine. Then, the patient undergoes Kinect training for 10 minutes followed by an actfulness exercise focusing on feelings of movement that focuses on sensations of movement and dynamic imagining of a planned activity. In the second session, patients are thought to restructure action memories. The intervention is based on the scaffolding of two well-known interventions: mindfulness meditation-movement meditations and memory restructuring. Deficient action simulations are rehabilitated by: (a) partial movements (alternating covert with dynamic-partial movements simulations in response to stimuli); (b) linguistic supports (training in gerundival perceptions, e.g., recognize and naming a stimuli by actions, e.g., a door to open), (c) enhanced perceptual and affective simulations and (d) episodic memory support (participants have to form future memories of action cores-last sequence of movement before the perception of desired environmental change, correct them by experience and remember at the end of the day). Thus, it is a rehearsal training including combined actual and mental practice with augmentation of the motor component of simulations in thinking by enhancing gestures, language and episodic memory as controls of simulation, and is applied to promote the use of motor simulations in everyday life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Fluent in written and spoken Romanian

• Reporting clinically significant depressive symptoms above cut-off on depression measures and by structured clinical interview

Exclusion Criteria:

• Elevated risk of suicide/Suicide intent and plans

• Current substance use disorder

• Current or previous manic/hypomanic episodes

• Current psychotic disorder

• Current diagnosis of dementia/major neurocognitive disorder

• Currently receiving psychological therapy

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Behavioral Activation plus Dynamic Mental Imagery
This intervention consists of an 8-session behavioural activation treatment with an added dynamic imagery exercise after each session. The dynamic imagery exercise is structured as follows: (1) the therapist explains the intervention; (2) the therapist models dynamic simulation skill (dynamic imagery) and repeats with the participant while giving appropriate feedback; (3) the participant completes a 10-minute Kinect training; (4) the participant completes a short Actfulness exercise that involves focusing on the feelings of movements of breathing and hands and dynamic imagery of one planned activity. From the second session, participants memorize daily activities forming a short dynamic memory of the activity focusing on feelings of movements.
• Behavioral activation
The BA intervention is a short 8 session behavioural intervention. Participants learn to monitor the activities, plan "anti-depressant" activities for the next week and find support for the implementation of the activity.

Locations

Country	Name	City	State
Romania	University of Oradea	Oradea	Bihor

Sponsors (2)

Lead Sponsor	Collaborator
University of Oradea	York University

Country where clinical trial is conducted

Romania, 

References & Publications (23)

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Martell, Christopher R., Sona Dimidjian, and Ruth Herman-Dunn. Behavioral activation for depression: A clinician's guide. Guilford Publications, 2021.

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Tiba A, Voss L. A motor imagery training for improving action cognition results in the reduction of residual symptoms after major depressive disorder: a single case study. Journal of Evidence- Based Psychotherapies. 2022: Vol. 22, No. 1, March 2022, 137- 168./ 10.24193/je bp.2022.1.8

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in depressive symptoms severity measured by Beck Depression Inventory II,	Beck Depression Inventory II is a 21-item questionnaire used to measure severity of depression. The score ranges from 0-63. Higher scores indicate higher depression.	Baseline; Intervention Week 8; 3 months post-intervention
Secondary	Change from baseline in depressive symptoms using the Patient Health Questionnaire 9	Patient Health Questionnaire 9 is a nine-item questionnaire used to identify depression as well as measuring severity of depression. The score ranges from 0-27. Higher scores indicate higher severity of depression.	Baseline; Intervention Week 1; Intervention Week 2; Intervention Week 3; Intervention Week 4; Intervention Week 5; Intervention Week 6; Intervention Week 7; Intervention Week 8; 3 months post-intervention
Secondary	Change from baseline in anhedonia symptoms using the Snaith-Hamilton Pleasure Scale	Snaith-Hamilton Pleasure Scale is a 14-item questionnaire used to measure anhedonia. The score ranges from 0-14. Higher scores indicate higher anhedonia.	Baseline; Intervention Week 8; 3 months post-intervention
Secondary	Changes from baseline in apathy level using Motivational Apathy Index	Motivational Apathy Index is an 18-item questionnaire used to identify three dimensions of apathy assessed with the mean score, which ranges from 0-4. Higher scores indicate higher apathy.	Baseline; Intervention Week 8; 3 months post-intervention
Secondary	Change from baseline in the diagnosis of depression assessed using the Structured Clinical Interview for DSM-5 Disorders -- Clinician Version	Structured Clinical Interview for DSM-5 Disorders is a structured clinical interview used to assess the presence/absence of common psychiatric disorders.	Baseline; Intervention Week 8
Secondary	Change from baseline in the health and disability level using The WHO Disability Assessment Schedule 12-item	he WHO Disability Assessment Schedule 12-item is a 12-item questionnaire used to assess disability due to health conditions. The total score ranges from 0-48. Higher scores indicate higher functioning.	Baseline; Intervention Week 8; 3 months post-intervention
Secondary	Scores for adverse and unwanted effects of the experimental intervention	Negative incidents and effects of psychological treatment scale is a 20-item questionnaire used to assess adverse and unwanted effects of psychological treatments. The total score ranges from 0-80. Higher scores indicate higher negative effects.	Week 8
Secondary	Change from baseline in the motor imagery is assessed at baseline using the Vividness of Motor Imagery Questionnaire-2	Vividness of Motor Imagery Questionnaire-2 is a 12-item questionnaire assessing the vividness of mental imagery. It has three subscales, each subscale having a total score ranging from 12-60. Higher scores indicate lower vividness of imagery.	Baseline; Intervention Week 6
Secondary	Change from baseline in affect and behaviour monitoring scale	The affect and behavior monitoring scale is 7-point Likert scale built for the present study to monitor weekly changes in functioning emotions, behaviour profile, efficacy, difficulty of simulation. For each item, the score ranges from 1 to 7. Higher scores mean higher functioning.	Baseline; Intervention Week 1; Intervention Week 2; Intervention Week 3; Intervention Week 4; Intervention Week 5; Intervention Week 6; Intervention Week 7; Intervention Week 8; 3 months post-intervention
Secondary	Change from baseline in the Environmental and Reward Observation Scale	The Environmental and Reward Observation Scale is a 10-item scale assessing the level of rewards. The total score ranges from 10-40. Higher scores indicate higher rewards.	Baseline; Intervention Week 6
Secondary	Change from baseline in the rumination style scale	The Rumination Style Scale scale is a short 10 item scale that measure the level of rumination. Scores ranges from a low of 14 to a high of 40. Higher scores indicate higher difficulties with rumination.	Baseline; Intervention Week 6
Secondary	Change from baseline in the behavioral activation level using The Behavioral Activation for Depression Scale - Short Form	The Behavioral Activation for Depression Scale is a nine-item questionnaire used to measure changes in avoidance and activation. The score ranges from 0-54. Higher scores indicate higher avoidance.	Baseline; Intervention Week 6; Intervention Week 8
Secondary	Change from baseline in Backward digit span task	In the Backward digit span task, participants are given a series of digits and asked to repeat them backward. The score is how many numbers of participants repeat backward. A higher score indicates better working memory	Baseline; Intervention Week 6 Intervention Week 8
Secondary	Change from baseline in verbal fluency task	In the verbal fluency task participants must generate as many words as possible starting with a consonant (F, S or T) in one minute. The score is the number of words in one minute for one letter. A higher score indicates better verbal fluency.	Baseline; Intervention Week 6; Intervention Week 8
Secondary	Change from baseline in verb fluency task	The verb fluency task asks participants to generate as many verbs as possible in one minute. The score is the number of verbs generated in one minute. A higher score indicates better verb fluency.	Baseline; Intervention Week 6; Intervention Week 8
Secondary	Change from baseline in anxiety symptoms using the Generalized Anxiety Disorder 7-item	Generalized Anxiety Disorder 7 is a seven-item questionnaire used to identify generalized anxiety disorder as well as measuring severity of anxiety symptoms. The score ranges from 0-21. Higher scores indicate higher severity of anxiety.	Baseline; Intervention Week 8
Secondary	Change from baseline in The Movement Imagery Questionnaire-3	The Movement Imagery Questionnaire-3 is a questionnaire consisting of total of 12 items to assess individual's ability to image four movements. It has two visual scales and a kinesthesic scale, scores range for each scale from 4 to 28 with a higher score representing a better mental imagery ability.	Baseline; Intervention Week 6
Secondary	Acceptability ratings	For acceptability ratings, the participants rate on a 5-points Likert scale their satisfaction, intention to continue and to recommend the intervention. Higher score means higher acceptability.	Week 8