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Attivazione comportamentale per la depressione: uno studio controllato randomizzato

4 novembre 2026 aggiornato da: Mia Skytte OToole, University of Aarhus

The present study is a randomized controlled trial that will evaluate two versions of behavioral activation (BA); one version which is a standard BA program and one which is a motor enhanced BA program (mBA). In both programs, the patient will receive all standard BA interventions, whereas these - in the mBA program - will be supplemented with interventions focused on noticing and manipulating posture and movement associated with action initiation. The mBA program builds upon recent evidence pointing to motor manipulations of posture and movement as having the potential to assist in action initiation and thus following through with the planned activity schedule. Previous research has shown that patient compliance with the activity schedule is causally associated with depression reduction, which will be explored as a mediator of treatment gains.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Depression is a leading cause of disability worldwide (WHO, 2020). Nationally, more than 10.000 new cases of depression are registered each year with a higher frequency in women (Sundhedsstyrelsen, 2015). With depression comes reduced quality of life for the affected individual and a great economic burden for society. For instance, collectively, people with depression have more than 600.000 more visits to their general practitioner (GP) than people without depression, and when employed, they have 1.7 million more sick days than people without depression (Sundhedsstyrelsen, 2015). Access to effective treatment is thus crucial. Behavioral activation (BA) is an efficacious psychological treatment for depression; its effect may exceed that of medication and is equal to that of cognitive behavioral therapy (CBT) (Cuijpers, van Straten, & Warmerdam, 2007; Ekers et al., 2014). BA is therefore recommended as a first-line psychological treatment for mild to moderate depression by the National Institute for Health and Care Excellence (NICE CG90; 2009).

Depression is often described with reference to the disorder's cognitive characteristics, such as the depressogenic content of thoughts ( Beck, Rush, Shaw, & Emery, 1979) and the tendency to engage rumination and self-criticism (e.g., Mennin & Fresco, 2013) as well as behavioral characteristics such as lack of motivation, avoidance, and withdrawal (e.g., Lewinsohn, 1974). Although less commonly found in the description of depression, research has also documented bodily characteristics, including alterations to the motor system. Concerning the motor system, gait patterns associated with sadness and depression have been characterized by reduced walking speed, arm swing, and vertical head movements (Michalak et al., 2009). Successful treatment of depression thus may include - not only improvements in cognition and behavior - but also normalization of the motor system.

Although CBT and BA produce similar results in the treatment of depression, they are rooted in different theoretical models of depression. Traditional CBTs target the depressed individual's dysfunctional appraisals. They do so by inviting the client to restructure their thinking and expose themselves to situations that will help them in this endeavor. This is based on the assumption that the root of the problematic behavior in depression, first and foremost, is a result of dysfunctional thinking (e.g., "it doesn't matter anyway", "I will always be depressed") ( Beck et al., 1979). BA, on the other hand, is primarily rooted in a behavioral theory of depression. It builds on Lewinsohn's (1974) seminal work, holding that depression is the result of a loss or lack of response-contingent positive reinforcement, leaving the patient stuck in a maladaptive pattern of behavioral avoidance and withdrawal, preventing them from having rewarding interactions with their surroundings. In order to combat this avoidance and withdrawal behavior permeating depression, the patient in BA is invited to monitor their activities - mapping the dysfunctional patterns - and then to engage in activities that are important and joyful, if not at first, then over time (Lejuez, Hopko, Acierno, Daughters, & Pagoto, 2011; Martell, Dimidjian, & Herman-Dunn, 2010). Indeed, in the beginning, certain activities may not feel instantly rewarding, and the depressed person may only have a vague memory of a time when that activity was associated with joy. However, in BA, patients are invited to try to act 'outside-in', instead of 'inside-out', meaning that they refrain from acting according to their mood (low mood will likely lead to more avoidance and withdrawal behavior) and instead approach the planned activity regardless of their current mood (i.e., outside-in).

Previous research has shown that patient compliance with the activity schedule is causally associated with depression reduction (Ryba et al., 2014). Thus, theoretically and empirically, following through with the activity schedule presents as one of the most important mediators of treatment gains. However, patients may struggle with initiating the planned activities. In a sense, BA asks patients to do exactly the thing they feel like they cannot do, that is, get up and get going. Despite psychoeducation about the rationale of the treatment, and even when clients get initial experience with the fact that they feel better and more competent after a certain activity, they may still struggle with action initiation (Martell et al., 2010). Recent evidence points to motor manipulations of posture and movement as having the potential to be an important supplementary intervention within BA, enhancing the likelihood that clients follow through with the planned activity schedule. In a recent meta-analysis, we investigated the effect of motor manipulations (i.e., expansive/upright and contractive/slumped postures) on affective and behavioral outcomes. Across studies, we found that the manipulation of motor activity altered mood, emotions, and actions such that when individuals adopt neutral or expansive postures, they reported better mood, more positive emotions, and engaged in more approach behavior than when assuming contractive postures (Elkjær et al., 2020). These results could suggest that adopting neutral or expansive postures could be helpful for depressed individuals in initiating action.

Building on the solid findings from previous BA trials and the recent findings concerning the effects of motor manipulations, the present study is a randomized controlled trial that will evaluate two versions of BA, one version which is a standard BA program (Lejuez et al., 2011) and one which is a motor enhanced BA program (mBA). In both programs, the patient will receive all standard BA interventions, whereas these - in the mBA program - will be supplemented with interventions focused on noticing and manipulating posture and movement associated with action initiation. One hundred and seventeen individuals diagnosed with major depressive disorder (MDD) will be randomized to active treatment or a 10-week waitlist followed by active treatment. The active treatment is also based upon randomization, where individuals will receive either standard BA or mBA, and will be followed for 6 months post treatment. In the active treatment, individuals will receive 10 weekly video sessions, conducted using the secure and GDPR-approved video-conference program 'Zoom'.

Before and after the mBA program, patients will partake in an experiment. The effect of motor manipulations on responses to two different personally relevant emotional conflicts will be evaluated. One emotional conflicts will be one that is typical of those detected in depression, where an individual wishes they could or would enjoy approaching a situation but lack the motivation to do so (i.e., approach vs. withdrawal). The other will be one in which an individual wishes they could approach a situation but feel scared or nervous about doing so (approach vs. avoidance). Participants will be randomized to one of three experimental conditions: adopting expansive postures, contractive postures, or neutral postures. Effects will be evaluated concerning action tendencies, behavioral self-efficacy and experienced emotions. For the experiment taking place before treatment, patients will be compared to a group of matched healthy controls.

Hypotheses

It is hypothesized that 1) both BA and mBA will be more efficacious in reducing symptoms of depression than the waitlist, and 2) gains are expected to be maintained through the follow-up period.

It is also expected that 3) mBA with its extra treatment component focused on the motor system will be superior to BA of at least small magnitude (d=0.3; Bell et al., 2013). This added benefit of mBA is expected to be driven by compliance with the activity schedule as it is hypothesized 4) that the mBA condition can increase success with planned activities (i.e., quantity of completed activities and proportion of completed activities). 5) This success with planned activities is expected to mediate treatment gains in both BA and mBA.

Concerning the experiment, before treatment, 6) it is expected that depressed patients to show less approach behavior (i.e., less approach action tendencies, less behavioral self-efficacy, , and less positive emotions) in response to the emotional conflicts compared with healthy controls. Furthermore, 7) it is hypothesized that participants assuming neutral and expansive postures will respond with more approach behavior than participants adopting contractive postures. 8) Effects will be explored between groups (healthy vs clinical), thereby determining if the neutral and expansive motor displays are more or less facilitative of approach behavior, and if the contractive motor displays are more or less detrimental to such behavior, depending on clinical status. 9) Effects will also be explored comparing the two types of emotional conflicts.

Concerning the experiment following treatment, 10) it is expected that any differences between the healthy and clinical group detected at baseline will diminish or disappear, reflecting clinical improvement and normalization following treatment.

Collaborators:

Mai B. Mikkelsen, Gitte Tramm, Emme Elkjær, Kaj Sparle Christensen, Douglas S. Mennin, & Johannes Michalak

Tipo di studio

Interventistico

Iscrizione (Effettivo)

107

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Aarhus, Danimarca, 8000
        • Aarhus University - Institute of Psychology and Behavioral Sciences

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Depressed participants:

Inclusion Criteria:

  • A principal diagnosis of major depressive disorder (MDD) according to DSM-5 of a mild to moderate severity, that is, a 4 on a 0 (no depressive symptoms) to 8 (very severe symptoms) scale according to the ADIS-5 interview.
  • Danish language proficiency.
  • Ability and willingness to give informed consent.
  • Be either non-medicated or stabilized [i.e., same dosage for a minimum of 8 weeks on antidepressant and antianxiety medication].
  • Access to either a smartphone, tablet, or computer with video camera

Exclusion Criteria:

  • Severe depression deemed to require more intense psychotherapy or medication.
  • Non-stabilized medication (see above).
  • A history of bipolar disorder.
  • Current or past psychosis.
  • Substance abuse or dependence judged to require treatment.
  • Suicide risk requiring immediate hospitalization.
  • Receiving any other current psychotherapy or counseling.

Healthy participants:

Will only be considered for participation if they can read and understand the Danish language and deemed able and willing to give informed consent. They will undergo diagnostic interviewing to ensure the absence of a current psychiatric diagnosis and the absence of a history of bipolar disorder or psyhosis according to the ADIS-5. They will also be excluded if they receive any psychotropic medication.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: mBA

Motor enhanced behavioral activation. 10 sessions.

Brief Behavioral Activation Treatment with and without motor enhancement. All patients will receive 10 online video sessions. BA focuses on increasing overt behaviors to bring patients into contact with reinforcing environmental contingencies and corresponding improvements in thoughts, mood, and quality of life (Hopko, Lejuez, et al., 2003). BA follows the basic behavioral principles of extinction, shaping, fading, and in vivo exposure (Hopko & Lejuez, 2007; Lejuez et al., 2001, 2011). In the mBA condition only a) patients will be introduced to the idea that the motor system can be used in the service of action initiation and will receive an audio recording with motor manipulations to assist in action initiation and b) the therapist will conduct imaginary behavioral activation and - in session - complete questionnaires identical to those in the experiment before and after the bodily instructions presented in the treatment.

Sperimentale: BA

Standard behavioral activation. 10 sessions.

Brief Behavioral Activation Treatment with and without motor enhancement. All patients will receive 10 online video sessions. BA focuses on increasing overt behaviors to bring patients into contact with reinforcing environmental contingencies and corresponding improvements in thoughts, mood, and quality of life (Hopko, Lejuez, et al., 2003). BA follows the basic behavioral principles of extinction, shaping, fading, and in vivo exposure (Hopko & Lejuez, 2007; Lejuez et al., 2001, 2011). In the mBA condition only a) patients will be introduced to the idea that the motor system can be used in the service of action initiation and will receive an audio recording with motor manipulations to assist in action initiation and b) the therapist will conduct imaginary behavioral activation and - in session - complete questionnaires identical to those in the experiment before and after the bodily instructions presented in the treatment.

Nessun intervento: Waitlist

10 week waitlist.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depressive symptoms (PHQ-9)
Lasso di tempo: Change from pre to post (10 weeks) active treatment.

Patient Health Questionnaire-9 (Spitzer et al., 1999; Spitzer et al., 2000)

Change from pre to post (10 weeks) active treatment.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depressive symptoms (PHQ-9)
Lasso di tempo: Change from pre-treatment through 6-months follow-up

Patient Health Questionnaire-9 (Spitzer et al., 1999; Spitzer et al., 2000)

Change from pre-treatment through 6-months follow-up
Number of recovered patients in BA/mBA vs. waitlist
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

Number cacluated according to the minimal clinically important difference for the PHQ-9 (i.e., 5 score points; Lowe, Unutzer, Callahan, Perkins, & Kroenke, 2004)

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Number of patients having obtained a reliable change in depressive symptoms in BA/mBA vs. waitlist
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

Calculated according to the reliable change index (Jacobsen & Truax, 1999) for the PHQ-9.

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Exposure to environmental rewards (EROS)
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

The Environmental Reward Observation Scale (Armento & Hopko, 2007)

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Intereoceptive awareness (MAIA)
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

The Multidimensional Assessment of Interoceptive Awareness, Version 2 (Mehling, Acree, Stewart, Silas, & Jones, 2018)

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Behavioral activation and inhibition (BIS/BAS)
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

BIAS/BAS (Carver & White, 1994)

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Perceived coping ability(CSES)
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

The Coping Self-Efficacy Scale (Chesney, Neilands, Chambers, Taylor, & Folkman, 2006

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Rumination (RRS)
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

The Ruminative Response Scale, brooding subscale (Treynor, Gonzalez, & Nolen-Hoeksema, 2003)

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Worry (PSWQ)
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

The Penn State Worry Questionnaire (Meyer, Miller, Metzger, & Borkovec, 1990)

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Decentering (EQ)
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

The Experiences Questionnaire Decentering subscale (Fresco et al., 2007)

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Dysfunctional attitudes (DAS)
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

Dysfuntional Attitude Scale SF1 (Beever et al., 2009; Weismann, 1979)

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up
Quality of life (QoL)
Lasso di tempo: Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

The World Health Organization (WHO)-5 questionnaire

Change form pre to post active treatment (10 weeks) and change from pre-treatment through 6-months follow-up

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
PHQ-9
Lasso di tempo: Session by session change during the 10 weeks of active treatment

Depressive symptoms will be evaluted session by session for mediation analyses

Session by session change during the 10 weeks of active treatment
EROS
Lasso di tempo: Session by session change during the 10 weeks of active treatment

Environmental rewards will be evaluted session by session for mediation analyses

Session by session change during the 10 weeks of active treatment
CSES
Lasso di tempo: Session by session change during the 10 weeks of active treatment

Coping ability will be evaluted session by session for mediation analyses

Session by session change during the 10 weeks of active treatment
RRS
Lasso di tempo: Session by session change during the 10 weeks of active treatment

Ruminaiton will be evaluted session by session for mediation analyses

Session by session change during the 10 weeks of active treatment
Activity log (kept by therapist)
Lasso di tempo: Session by session change during the 10 weeks of active treatment

Quantity and proportion of activities will be calculated for mediation analyses

Session by session change during the 10 weeks of active treatment
EQ
Lasso di tempo: Session by session change during the 10 weeks of active treatment

Decentering ability will be tested as a competing mediator

Session by session change during the 10 weeks of active treatment
DAS
Lasso di tempo: Session by session change during the 10 weeks of active treatment

Dysfunctional attitudes will be tested as a competing mediator

Session by session change during the 10 weeks of active treatment
Overall activity level
Lasso di tempo: Session by session change during the 10 weeks of active treatment

Total steps taken (measured by pedometer) and exercise each day will be tested as a competing mediator

Session by session change during the 10 weeks of active treatment
Perceived importance of activity
Lasso di tempo: Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)

"How important is the activity to you?". Outcome in experiment (7-point Likert scale from 1 to 7)

Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)
Expected effect of activity on mood
Lasso di tempo: Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)

"How do you expect the activity to affect your mood?" Outcome in experiment (7-point Likert scale from -3 [negative] to +3 [positive])

Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)
Perceived self-efficacy concerning activity
Lasso di tempo: Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)

"How confident do you feel about your ability yo take the activity?". Outcome in experiment (7-point Likert scale from 1 to 7)

Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)
Perceived difficulty of completing activity
Lasso di tempo: Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)

"How difficult is it for you to do the activity". Outcome in experiment (7-point Likert scale from 1 to 7)

Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)
Degree of avoidance and withdrawal motivation concerning activity
Lasso di tempo: Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)

Withdrawal: "I do no feel like or have the energy to complete the activity." Avoidance: "I am scared, nervous or worried about doing the activity". Outcome in experiment (7-point Likert scale from 1 to 7)

Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)
Action tendencies (DAT; O'Toole & Mikkelsen, 2020) concerning activity
Lasso di tempo: Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)

Outcome in experiment (8 drawings rated on a 5-point Likert scale from 1 to 5)

Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)
Negative and positive emotions when thinking about doing activity
Lasso di tempo: Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)

8 negative and 7 positive emotions used as outcome in experiment (5-point Likert scale from 1 to 5)

Change from pre to post experimental manipulation (10 minutes) (pre-treatment only for healthy participants, pre- and post-treatment for depressed participants)
State rumination (Brief State Rumination Inventory [BRSI]; Marchetti, Mor, Chiorri, & Koster, 2018)
Lasso di tempo: Obtained post experiment only

Outcome in experiment (statements rated from 0 to 100)

Obtained post experiment only

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 gennaio 2021

Completamento primario (Effettivo)

31 luglio 2025

Completamento dello studio (Effettivo)

31 dicembre 2025

Date di iscrizione allo studio

Primo inviato

21 dicembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

5 gennaio 2021

Primo Inserito (Effettivo)

8 gennaio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BA Dep 20

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .