Clinical trial NCT05625230: Treatment for Rehabilitation of Action Cognition in Depression
Official title: Testing the Efficiency of a Psychological Treatment for the Rehabilitation of Action Cognition in Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
Behavioural Activation
Dynamic Imagery
Kinect
Lead sponsor: University of Oradea
Sponsor class: OTHER
Collaborators: name: York University
First posted: 2022-11-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in depressive symptoms severity measured by Beck Depression Inventory II,
timeFrame: Baseline; Intervention Week 8; 3 months post-intervention
Secondary outcomes:
measure: Change from baseline in depressive symptoms using the Patient Health Questionnaire 9
timeFrame: 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
measure: Change from baseline in anhedonia symptoms using the Snaith-Hamilton Pleasure Scale
timeFrame: Baseline; Intervention Week 8; 3 months post-intervention
measure: Changes from baseline in apathy level using Motivational Apathy Index
timeFrame: Baseline; Intervention Week 8; 3 months post-intervention
measure: Change from baseline in the diagnosis of depression assessed using the Structured Clinical Interview for DSM-5 Disorders -- Clinician Version
timeFrame: Baseline; Intervention Week 8
measure: Change from baseline in the health and disability level using The WHO Disability Assessment Schedule 12-item
timeFrame: Baseline; Intervention Week 8; 3 months post-intervention
measure: Scores for adverse and unwanted effects of the experimental intervention
timeFrame: Week 8
measure: Change from baseline in the motor imagery is assessed at baseline using the Vividness of Motor Imagery Questionnaire-2
timeFrame: Baseline; Intervention Week 6
measure: Change from baseline in affect and behaviour monitoring scale
timeFrame: 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
measure: Change from baseline in the Environmental and Reward Observation Scale
timeFrame: Baseline; Intervention Week 6
measure: Change from baseline in the rumination style scale
timeFrame: Baseline; Intervention Week 6
measure: Change from baseline in the behavioral activation level using The Behavioral Activation for Depression Scale - Short Form
timeFrame: Baseline; Intervention Week 6; Intervention Week 8
measure: Change from baseline in Backward digit span task
timeFrame: Baseline; Intervention Week 6 Intervention Week 8
measure: Change from baseline in verbal fluency task
timeFrame: Baseline; Intervention Week 6; Intervention Week 8
measure: Change from baseline in verb fluency task
timeFrame: Baseline; Intervention Week 6; Intervention Week 8
measure: Change from baseline in anxiety symptoms using the Generalized Anxiety Disorder 7-item
timeFrame: Baseline; Intervention Week 8
measure: Change from baseline in The Movement Imagery Questionnaire-3
timeFrame: Baseline; Intervention Week 6
measure: Acceptability ratings
timeFrame: Week 8
Other outcomes:
Locations:
city: Oradea
country: Romania
facility: University of Oradea
state: Bihor
Study officials:
affiliation: University of Oradea
name: Alexandru Tiba, PhD
role: STUDY_DIRECTOR
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