DepressionT-RACNCT05625230
Treatment for Rehabilitation of Action Cognition in Depression
A study testing Behavioral Activation plus Dynamic Mental Imagery and Behavioral activation in people with Depression, run by University of Oradea at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation plus Dynamic Mental Imagery and Behavioral activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteRomania
- Study dates
- 15 Mar 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in written and spoken Romanian
- Reporting clinically significant depressive symptoms above cut-off on depression measures and by structured clinical interview
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
University of Oradea
Oradea, Bihor County, 410087
Alexandru Tiba, PhD, +40 754 598 233, alexandrutiba@gmail.com
Alexandru Tiba, PhD
About this study
Official title: Testing the Efficiency of a Psychological Treatment for the Rehabilitation of Action Cognition in Depression
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.
Read the 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
- Being tested
- Behavioral Activation plus Dynamic Mental Imagery, Behavioral activation
- Keywords
- Depression, Behavioural Activation, Dynamic Imagery, Kinect
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation plus Dynamic Mental ImageryBehavioural
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.
Behavioral activationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Intervention Week 8; 3 months post-intervention
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start15 Mar 2023
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oradea
- Sponsor type
- University, hospital or other
- Collaborators
- York University
- Responsible party
- Sponsor
- Investigators
- Alexandru Tiba, PhD, Study director, University of Oradea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625230
- Sponsor's protocol ID
- PN-III-P1-1.1-TE-2021-1090
- Acronym
- T-RAC
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Martell, Christopher R., Sona Dimidjian, and Ruth Herman-Dunn. Behavioral activation for depression: A clinician's guide. Guilford Publications, 2021.
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.
PubMed 28076387Beshai 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.
PubMed 22020371Bortolato 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.
PubMed 26801406Chen 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.
PubMed 23684121Gorwood 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.
PubMed 25129432Shadmehr 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.
PubMed 20367317Glenberg 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.
PubMed 26271505Tiba 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
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
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.
PubMed 15561502Malouin 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.
PubMed 24065903Rush 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.
PubMed 12946886Snaith 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.
PubMed 7551619First 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficiency of a Psychological Treatment for the Rehabilitation of Action Cognition in Depression
- ClinicalTrials.gov ID
- NCT05625230
- Acronym / sponsor ID
- T-RAC / PN-III-P1-1.1-TE-2021-1090
- Conditions
- Depression
- Keywords
- Depression, Behavioural Activation, Dynamic Imagery, Kinect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of OradeaUniversity, hospital or other
- Collaborators
- York University
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavior activation-PLUS T-RAC | Experimental | Behavioral: Behavioral Activation plus Dynamic Mental ImageryBehavioral: 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. |
| Arm 2 Behavioral activation | Active comparator | Behavioral: Behavioral activationBehavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fluent in written and spoken Romanian
- Reporting clinically significant depressive symptoms above cut-off on depression measures and by structured clinical interview
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation plus Dynamic Mental ImageryThis 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. | Behavioural | Behavior activation-PLUS T-RAC |
| Behavioral activationThe 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. | Behavioural | Arm 2 Behavioral activation |
Primary outcome
Change from baseline in depressive symptoms severity measured by Beck Depression Inventory II,
Time frame: Baseline; Intervention Week 8; 3 months post-intervention
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.
17 secondary outcomes
Change from baseline in depressive symptoms using the Patient Health Questionnaire 9
Time frame: 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
Time frame: Baseline; Intervention Week 8; 3 months post-intervention
Changes from baseline in apathy level using Motivational Apathy Index
Time frame: 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
Time frame: Baseline; Intervention Week 8
Change from baseline in the health and disability level using The WHO Disability Assessment Schedule 12-item
Time frame: Baseline; Intervention Week 8; 3 months post-intervention
Scores for adverse and unwanted effects of the experimental intervention
Time frame: Week 8
Change from baseline in the motor imagery is assessed at baseline using the Vividness of Motor Imagery Questionnaire-2
Time frame: Baseline; Intervention Week 6
Change from baseline in affect and behaviour monitoring scale
Time frame: 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
Time frame: Baseline; Intervention Week 6
Change from baseline in the rumination style scale
Time frame: Baseline; Intervention Week 6
Change from baseline in the behavioral activation level using The Behavioral Activation for Depression Scale - Short Form
Time frame: Baseline; Intervention Week 6; Intervention Week 8
Change from baseline in Backward digit span task
Time frame: Baseline; Intervention Week 6 Intervention Week 8
Change from baseline in verbal fluency task
Time frame: Baseline; Intervention Week 6; Intervention Week 8
Change from baseline in verb fluency task
Time frame: Baseline; Intervention Week 6; Intervention Week 8
Change from baseline in anxiety symptoms using the Generalized Anxiety Disorder 7-item
Time frame: Baseline; Intervention Week 8
Change from baseline in The Movement Imagery Questionnaire-3
Time frame: Baseline; Intervention Week 6
Acceptability ratings
Time frame: Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- BackgroundMartell, Christopher R., Sona Dimidjian, and Ruth Herman-Dunn. Behavioral activation for depression: A clinician's guide. Guilford Publications, 2021.
- Background: PubMed 28076387Ang 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.
- Background: PubMed 22020371Beshai 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.
- Background: PubMed 26801406Bortolato 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.
- Background: PubMed 23684121Chen 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.
- Background: PubMed 25129432Gorwood 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.
- Background: PubMed 20367317Shadmehr 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.
- Background: PubMed 26271505Glenberg 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.
- BackgroundTiba 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
- BackgroundHolmes 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
- Background: PubMed 15561502Courtine 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.
- Background: PubMed 24065903Malouin 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.
- Individual participant dataSharing planned: Yes
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Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandru Tiba, PhD study director
University of Oradea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation plus Dynamic Mental Imagery and Behavioral activation in people with Depression, run by University of Oradea at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandru Tiba, PhD (+40 754 598 233, alexandrutiba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in depressive symptoms severity measured by Beck Depression Inventory II, (time frame: Baseline; Intervention Week 8; 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05625230, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.