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Treatment for Rehabilitation of Action Cognition in Depression (T-RAC)

U

University of Oradea

Status

Enrolling

Conditions

Depression

Treatments

Behavioral: Behavioral activation
Behavioral: Behavioral Activation plus Dynamic Mental Imagery

Study type

Interventional

Funder types

Other

Identifiers

NCT05625230
PN-III-P1-1.1-TE-2021-1090

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

110 participants in 2 patient groups

Behavior activation-PLUS T-RAC
Experimental group
Description:
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.
Treatment:
Behavioral: Behavioral Activation plus Dynamic Mental Imagery
Arm 2 Behavioral activation
Active Comparator group
Description:
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.
Treatment:
Behavioral: Behavioral activation

Trial contacts and locations

1

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Central trial contact

Alexandru Tiba, PhD; ioana sirbu

Data sourced from clinicaltrials.gov

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