Treatment for Rehabilitation of Action Cognition in Depression

NCT05625230 | Unknown

• 1 other identifier: PN-III-P1-1.1-TE-2021-1090
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Behavioural Activation; Dynamic Imagery; Kinect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Change from baseline in depressive symptoms using the Patient Health Questionnaire 9

  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

  Baseline; Intervention Week 8; 3 months post-intervention

• Changes from baseline in apathy level using Motivational Apathy Index

  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

  Baseline; Intervention Week 8

• Change from baseline in the health and disability level using The WHO Disability Assessment Schedule 12-item

  Baseline; Intervention Week 8; 3 months post-intervention

Study Arms (2)

Behavior activation-PLUS T-RAC

EXPERIMENTAL

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

Arm 2 Behavioral activation

ACTIVE COMPARATOR

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

Interventions

Behavioral Activation plus Dynamic Mental Imagery 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.

Behavior activation-PLUS T-RAC

Behavioral activation 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.

Arm 2 Behavioral activation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in written and spoken Romanian
• Reporting clinically significant depressive symptoms above cut-off on depression measures and by structured clinical interview

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oradea: lead
• York University: collaborator

Study Sites (1)

University of Oradea

Oradea, Bihor County, 410087, Romania

RECRUITING

Related Publications (23)

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  BACKGROUND

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  PMID: 26271505 BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  PMID: 24065903 BACKGROUND

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  PMID: 12946886 BACKGROUND

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  PMID: 7551619 BACKGROUND

• 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.

  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.

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  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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 27461440 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Alexandru Tiba, PhD

  University of Oradea

  STUDY DIRECTOR

Central Study Contacts

Alexandru Tiba, PhD

CONTACT

+40 754 598 233; alexandrutiba@gmail.com

ioana sirbu

CONTACT

+40748194311; ioana.uoradea@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessors are blind to the conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 22, 2022
• Study Start: March 15, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: May 23, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From June/July 2023

Locations

RO (1)