Behavioral Activation for Depression: A Randomized Controlled Trial

NCT04700774 | Active Not Recruiting DMC

• 1 other identifier: BA Dep 20
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms (PHQ-9)

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

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

Secondary Outcomes (12)

• Depressive symptoms (PHQ-9)

  Change from pre-treatment through 6-months follow-up

• Number of recovered patients in BA/mBA vs. waitlist

  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

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

• Exposure to environmental rewards (EROS)

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

• Intereoceptive awareness (MAIA)

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

Other Outcomes (16)

• PHQ-9

  Session by session change during the 10 weeks of active treatment

• EROS

  Session by session change during the 10 weeks of active treatment

• CSES

  Session by session change during the 10 weeks of active treatment

Study Arms (3)

mBA

EXPERIMENTAL

Motor enhanced behavioral activation. 10 sessions.

Behavioral: Behavioral activation

BA

EXPERIMENTAL

Standard behavioral activation. 10 sessions.

Behavioral: Behavioral activation

Waitlist

NO INTERVENTION

10 week waitlist.

Interventions

Behavioral activation BEHAVIORAL

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.

BA; mBA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University - Institute of Psychology and Behavioral Sciences

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It will not be known to participants whether they receive standard BA or mBA.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Participants will be randomized to active treatment or a 10-week waitlist followed by active treatment (BA or mBA). 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.

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 8, 2021
• Study Start: January 20, 2021
• Primary Completion: September 3, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

DK (1)