Clinical trial NCT06312241: Metacognitive Training-Silver BeWell in Older Adults
Official title: Feasibility, Acceptance and Efficacy of Metacognitive Training-Silver BeWell in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Well-Being, Psychological
Keywords: Metacognitive Training
intervention
older adults
cognitive-behavioral therapy
MCT-Silver
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study seeks to examine the feasibility, acceptance and efficacy of Metacognitive Training-Silver (MCT-Silver) BeWell among older adults (ages 60 years and older) delivered in a community setting (e.g., social-psychiatric community center, nursing homes, etc.).

Detailed description: Up to 20% of older adults have major depression and up to 30% have subclinical depressive symptoms (e.g., symptoms of depression that do not fulfill criteria for a major depressive episode). Given that depression in later life is associated with the onset of dementia and disability and that older adults have a higher risk of suicide and a longer time to remission, prompt treatment of subclinical depression and prevention of depression in later life is of importance. However, there is a lack of empirically-based, low-threshold and cost-effective group interventions for older adults, which can be delivered in community settings (e.g., community centers or nursing homes) by community mental health workers.

To fill this gap, the present study seeks to examine the feasibility, acceptance and efficacy of Metacognitive Training-Silver (MCT-Silver) BeWell among older adults (ages 60 years and older) delivered in a community setting (e.g., social-psychiatric community center, nursing homes, etc.). MCT-Silver BeWell is a standardized, cognitive-behavioral therapy based group intervention, which aims to improve insight for and reduce negative (meta)cognitive beliefs (e.g., negative mental filter), unhelpful behaviors (e.g., social withdrawal) and emotion-regulation (ER) strategies (e.g. rumination, avoidance of negative feelings) associated with the onset of depression. Like its forerunners, metacognitive training for psychosis (MCT) and depression in younger and middle-aged adults (D-MCT), MCT-Silver BeWell also aims at correcting information-processing biases (e.g., mood-congruent memory) associated with reduced mood and psychological well-being. In MCT-Silver BeWell sessions, psychoeducation regarding the association between negative (meta)cognitive beliefs and information-processing biases, ER strategies and behaviors with psychological well-being is presented and alternative, more helpful thoughts, strategies and skills are introduced and practiced with the aim of improving overall psychological well-being.

MCT-Silver for depression yielded significant effects beyond an active control group on self-reported depression, rumination and self-reported health in an outpatient setting with older adults with affective disorders, A pilot study of D-MCT among older adults also demonstrated the feasibility of the depression intervention in an inpatient setting and randomized clinical trials of D-MCT with adult sample have demonstrated the short and mid-term efficacy of D-MCT as well as session-specific effects, acceptance and (minimal) side effects.

In the current study, the investigator examine the acceptance, feasibility and efficacy of MCT-Silver BeWell among older adults. The number of sessions attended will serve as the primary outcome. Group attendance is expected to be high. Further outcomes include participants' acceptance (subjective ratings) as well as negative side effects of the intervention. It is expected that participants will rate the intervention positively and will report few negative side effects of the intervention. Other secondary outcomes include depression, resilience, loneliness, self-reported health, dysfunctional beliefs, and rumination

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age 60 years or older
* Sufficient command of the German language
* Willingness to participate in intervention over a period of 10 weeks (participants who do not attend the intervention, but complete questionnaires will also be included in the analysis)
* Visual and auditory acuity adequate for participation in group sessions
* Ability to participate in the group setting (ability to participate in the group setting will be assessed during a screening interview (e.g., adequate social skills)).

Exclusion Criteria:

* Acute suicidality as assessed by BDI-II Item 9
* Dementia (MMSE \< 24) or evidence of severe organic brain dysfunction

Primary outcomes:
measure: Number of sessions attended
timeFrame: 10 weeks (pre (t0)- to post (t1))
Secondary outcomes:
measure: Participants' appraisal of the training
timeFrame: after each session weeks 1 through 10; post (10 weeks; t1) and follow-up (3 months; t2)
measure: Negative effects questionnaire (NEQ)
timeFrame: post (10 weeks; t1) and follow-up (3 months; t2)
measure: Depression (Beck Depression Inventory - II)
timeFrame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
measure: Dysfunctional beliefs (18-item Dysfunctional Attitudes Scale)
timeFrame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
measure: Mental Well-Being (Warwick-Edinburgh Mental Well-being Scale)
timeFrame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
measure: Resilience (Resilience Scale)
timeFrame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
measure: Rumination (Ruminative Responses Scale)
timeFrame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
measure: Loneliness (UCLA Loneliness scale)
timeFrame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
measure: Self-rated health (EQ5D5L Visual Analog Scale )
timeFrame: baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)
measure: Session-specific effects
timeFrame: Before and after each session weeks 1 through 10
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Brooke Viertel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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