Treatment for Rehabilitation of Action Cognition in Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Behavioral Activation plus Dynamic Mental Imagery
* Behavioral: Behavioral activation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavior activation-PLUS T-RAC<br>Behavioral: Behavior activation/BA plus T-RAC Each session is focused on reviewing the activity log, planning anti-depressant activities for the next week, and finding support for the implementation of the activity. After activity planning, the participants will follow an XboxKinect exergame for 10 minutes, an actfulness exercise and will imagine one planned activity using dynamic imagery. From session 2 restructuring action memories are added. | Behavioral: Behavioral Activation plus Dynamic Mental Imagery<br>* 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.<br>|
| Active Comparator: Arm 2 Behavioral activation<br>Behavioral: Behavior activation/BA Participants in the behavioral activation arm will undergo a BA procedure. A therapist will administer an 8 sessions behavioral activation intervention based on the manual used in the COBRA trial. Each session is focused on reviewing the activity log, planning anti-depressant activities for the next week, and finding support for the implementation of the activity. | Behavioral: Behavioral activation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Behavioural Activation, Dynamic Imagery, Kinect