Treatment for Rehabilitation of Action Cognition in Depression

NCT ID: NCT05625230

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-05-15

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Behavior activation-PLUS T-RAC

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.

Group Type: EXPERIMENTAL

Behavioral Activation plus Dynamic Mental Imagery

Intervention Type: BEHAVIORAL

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.

Arm 2 Behavioral activation

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.

Group Type: ACTIVE_COMPARATOR

Behavioral activation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

York University

OTHER

Sponsor Role: collaborator

University of Oradea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandru Tiba, PhD

Role: STUDY_DIRECTOR

University of Oradea

Locations

University of Oradea

Oradea, Bihor County, Romania

Site Status: RECRUITING

Countries

Romania

Central Contacts

Alexandru Tiba, PhD

Role: CONTACT

alexandrutiba@gmail.com

+40 754 598 233

ioana sirbu

Role: CONTACT

ioana.uoradea@gmail.com

+40748194311

Facility Contacts

Alexandru Tiba, PhD

Role: primary

alexandrutiba@gmail.com

+40 754 598 233

References

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

Reference Type: BACKGROUND

Ang YS, Lockwood P, Apps MA, Muhammed K, Husain M. Distinct Subtypes of Apathy Revealed by the Apathy Motivation Index. PLoS One. 2017 Jan 11;12(1):e0169938. doi: 10.1371/journal.pone.0169938. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28076387 (View on PubMed)

Beshai S, Dobson KS, Bockting CL, Quigley L. Relapse and recurrence prevention in depression: current research and future prospects. Clin Psychol Rev. 2011 Dec;31(8):1349-60. doi: 10.1016/j.cpr.2011.09.003. Epub 2011 Sep 17.

Reference Type: BACKGROUND

PMID: 22020371 (View on PubMed)

Bortolato B, Miskowiak KW, Kohler CA, Maes M, Fernandes BS, Berk M, Carvalho AF. Cognitive remission: a novel objective for the treatment of major depression? BMC Med. 2016 Jan 22;14:9. doi: 10.1186/s12916-016-0560-3.

Reference Type: BACKGROUND

PMID: 26801406 (View on PubMed)

Chen J, Yang LQ, Zhang ZJ, Ma WT, Wu XQ, Zhang XR, Wei DH, Fu QH, Liu GX, Deng ZH, Hua Z, Zhang Y, Jia T. The association between the disruption of motor imagery and the number of depressive episodes of major depression. J Affect Disord. 2013 Sep 5;150(2):337-43. doi: 10.1016/j.jad.2013.04.015. Epub 2013 May 16.

Reference Type: BACKGROUND

PMID: 23684121 (View on PubMed)

Gorwood P, Richard-Devantoy S, Bayle F, Clery-Melin ML. Psychomotor retardation is a scar of past depressive episodes, revealed by simple cognitive tests. Eur Neuropsychopharmacol. 2014 Oct;24(10):1630-40. doi: 10.1016/j.euroneuro.2014.07.013. Epub 2014 Aug 2.

Reference Type: BACKGROUND

PMID: 25129432 (View on PubMed)

Shadmehr R, Smith MA, Krakauer JW. Error correction, sensory prediction, and adaptation in motor control. Annu Rev Neurosci. 2010;33:89-108. doi: 10.1146/annurev-neuro-060909-153135.

Reference Type: BACKGROUND

PMID: 20367317 (View on PubMed)

Glenberg AM. Embodiment as a unifying perspective for psychology. Wiley Interdiscip Rev Cogn Sci. 2010 Jul;1(4):586-596. doi: 10.1002/wcs.55. Epub 2010 Apr 8.

Reference Type: BACKGROUND

PMID: 26271505 (View on PubMed)

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

Reference Type: BACKGROUND

Holmes PS, Collins DJ. The PETTLEP Approach to Motor Imagery: A Functional Equivalence Model for Sport Psychologists. Journal of Applied Sport Psychology. 2001: 13:1, 60-83, DOI: 10.1080/10413200109339004

Reference Type: BACKGROUND

Courtine G, Papaxanthis C, Gentili R, Pozzo T. Gait-dependent motor memory facilitation in covert movement execution. Brain Res Cogn Brain Res. 2004 Dec;22(1):67-75. doi: 10.1016/j.cogbrainres.2004.07.008.

Reference Type: BACKGROUND

PMID: 15561502 (View on PubMed)

Malouin F, Jackson PL, Richards CL. Towards the integration of mental practice in rehabilitation programs. A critical review. Front Hum Neurosci. 2013 Sep 19;7:576. doi: 10.3389/fnhum.2013.00576.

Reference Type: BACKGROUND

PMID: 24065903 (View on PubMed)

Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.

Reference Type: BACKGROUND

PMID: 12946886 (View on PubMed)

Snaith RP, Hamilton M, Morley S, Humayan A, Hargreaves D, Trigwell P. A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995 Jul;167(1):99-103. doi: 10.1192/bjp.167.1.99.

Reference Type: BACKGROUND

PMID: 7551619 (View on PubMed)

First B, Williams JB, Karg RS, Spitzer RL. Structured Clinical Interview for DSM-5 Disorders, Clinician Version (SCID-5-CV) 2015: Arlington, VA: American Psychiatric Association.

Reference Type: BACKGROUND

Manos RC, Kanter JW, Luo W. The behavioral activation for depression scale-short form: development and validation. Behav Ther. 2011 Dec;42(4):726-39. doi: 10.1016/j.beth.2011.04.004. Epub 2011 Jun 1.

Reference Type: BACKGROUND

PMID: 22036000 (View on PubMed)

Rozental A, Kottorp A, Forsstrom D, Mansson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019 Sep;47(5):559-572. doi: 10.1017/S1352465819000018. Epub 2019 Mar 15.

Reference Type: BACKGROUND

PMID: 30871650 (View on PubMed)

Callow N, Roberts R. Imagery research: An investigation of three issues. Psychology of Sport & Exercise.2010: 11, 325-329.

Reference Type: BACKGROUND

Armento ME, Hopko DR. The Environmental Reward Observation Scale (EROS): development, validity, and reliability. Behav Ther. 2007 Jun;38(2):107-19. doi: 10.1016/j.beth.2006.05.003. Epub 2006 Dec 12.

Reference Type: BACKGROUND

PMID: 17499078 (View on PubMed)

Treynor W, Gonzalez R, Nolen-Hoeksema S. Rumination reconsidered: a psychometric analysis. Cogn Ther Res. 2003;27(3):247-59.

Reference Type: BACKGROUND

Martell CR, Addis ME, Jacobson NS. Depression in context: Strategies for guided action. 2001: W W Norton & Co.

Reference Type: BACKGROUND

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type: BACKGROUND

PMID: 11556941 (View on PubMed)

Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.

Reference Type: BACKGROUND

PMID: 27461440 (View on PubMed)

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id