Psychological Treatment to Support the Consequences of Cognitive Impairment

NCT04356924 | Recruiting

• 1 other identifier: KIPT6692021
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The burden of cognitive impairment is severe, and often hinders affected people to act independently in daily life. Individuals in different stages of cognitive decline are frequently affected by existential distress and associated health issues (such as stress symptoms, anxiety, and depression), as well as social avoidance due to the unclear prognosis. Although the need for psychological support is large, there is a lack of efficient individualized psychological treatments- and methods to maintain psychological health that sufficiently impact daily life and promote behavioral- and biological change. In keeping with that notion, the investigators have developed a novel psychological treatment manual focused on supporting individuals with early phase cognitive impairment. The treatment manual is centered on facilitating behavioral change in accordance with personal values and long-term goals even in the presence of negative experiences, as well as to promote meaningful life-style changes. Conceptually, the treatment manual has its basis in the cognitive behavioral therapy (CBT) tradition, but the investigators have strived to adapt the manual to suit a cognitively affected population. The investigators will evaluate the psychological treatment in a RCT were the investigators will include approximately 138 individuals in their early phases of cognitive decline and randomize them into either an experimental group (psychological treatment), an active control group (cognitive training), or a treatment as usual control group. Evaluations will be conducted with, psychological health measures, cognitive assessments, and with biological markers. The investigators hypothesize that in comparison with the control conditions, the response to psychological treatment will be associated with improved psychological health and improved cellular protection.

Conditions

Cognitive Impairment; Psychological; Psychotherapy; Health Behavior

Keywords

Cognitive impairment; Psychological treatment; Dementia prevention

Outcome Measures

Primary Outcomes (1)

• Change in psychological flexibility measured with the Acceptance and action questionnaire (AAQ2)

  A psychological health measure (questionaire) measuring the ability to notice and accept interfering thoughts, emotions and bodily sensations without acting on them, to facilitate behaving in accordance with personal values and long-term goals also in the presence of those negative experiences. Scores: 0-49 A low score indicate a more positive outcome.

  Measurement 1: 1 week prior to the intervention. Measurement 2: Change in AAQ2 from pre-intervention at 1 week post-intervention. Measurement 3: Change in AAQ2 from 1 week post-intervention at 6-month post intervention.

Secondary Outcomes (19)

• Change in perceived stress scale (PSS)

  Measurement 1: 1 week prior to the intervention. Measurement 2: Change in PSS from pre-intervention at 1 week post-intervention. Measurement 3: Change in PSS from 1 week post-intervention at 6-month post intervention.

• Change in Becks Depression Inventory (BDI)

  Measurement 1: 1 week prior to the intervention. Measurement 2: Change in BDI from pre-intervention at 1 week post-intervention. Measurement 3: Change in BDI from 1 week post-intervention at 6-month post intervention.

• Change in Brunnsvikens Brief Quality of Life Scale (BBQ)

  Measurement 1: 1 week prior to the intervention. Measurement 2: Change in BBQ from pre-intervention at 1 week post-intervention. Measurement 3: Change in BBQ from 1 week post-intervention at 6-month post intervention.

• Change in Short Form Health Survey (SF-36)

  Measurement 1: 1 week prior to the intervention. Measurement 2: Change in SF-36 from pre-intervention at 1 week post-intervention. Measurement 3: Change in SF-36 from 1 week post-intervention at 6-month post intervention.

• Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)

  Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention.

Study Arms (3)

Psychological treatment

EXPERIMENTAL

The psychological treatment consists of 11 sessions (55 minutes per occasion), where the patient meets a psychologist face-to-face (either licensed or under training to be licensed) once a week. In between sessions, patients are supposed to complete homework exercises that are related to the contiguous sessions (2 x 45 minutes per week).

Behavioral: Psychological treatment

Cognitive training

ACTIVE COMPARATOR

Like the experimental group, the active control group also consists of 11 sessions (55 minutes per occasion), once a week. At those occasions, the patient will meet a psychology student under training or a MSc in psychology that coaches the patients during the cognitive training. In between sessions, patients are supposed to take 2 walks (45 minutes per occasion to meaningfully match the home exercises in the experimental group).

Behavioral: Cognitive training

Treatment as usual

NO INTERVENTION

This group receives no intervention. They receive regular health information that is given after the extended cognitive examination at the Cognitive Centers. However, after the finalization of the post-intervention evaluations, this group will be randomized to participate in one of the active interventions. We will conduct additional post-intervention assessments also for those individuals in this group that accept this offer to increase the power of the intervention evaluation.

Interventions

Psychological treatment BEHAVIORAL

The treatment is an adjusted (to the cognitively impaired individual) combination of CBT, ACT, validation strategies, and psychoeducation. One focus is to increase motivation to lifestyle changes, and to a larger degree live life in correspondence with internal goals.

Psychological treatment

Cognitive training BEHAVIORAL

Computer based training tasks implemented with adaptive intensity. The cognitive training method that will be used is mainly related to executive control (i.e., ability to coordinate thoughts and actions in accordance with internal goals).

Cognitive training

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Criteria's for inclusion * \< 75 years. * SCD or MCI diagnosis. All cognitive MCI-subtypes are eligible. * Mild to moderate psychological symptoms that are indicated to be related to the patient's CI. The psychological symptoms should affect the patients daily living and behavior, exemplified by avoidance behavior, social anxiety and perceived stigmatization. * Fluency in the Swedish language. * The patients should have access to a mobile telephone to be able to receive reminders via Short Message Service (SMS). * Signed informed consent. * Criteria's for exclusion * Dementia diagnosis and/or occurrence of serious illness and/or injury that requires immediate investigation or treatment of another type, or which is expected to worsen in the coming year (i.e., not including dementia) * Severe psychiatric comorbidity (e.g., high suicide risk), and/or severe psychiatric disorder. This will be assessed in the MINI evaluation and during the clinical cognitive examination). * Anti-depressant medication introduced or alterations in dosage \< 6 months ago (i.e., un-stable dose). * Mini Mental State Examination (MMSE) score \< 26 and/or a Montreal Cognitive Assessment (MoCA) score \< 24. * Stroke or head trauma \< 6 months ago. * Substance abuse

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 17164, Sweden

RECRUITING

Related Publications (6)

• Wallin A, Kettunen P, Johansson PM, Jonsdottir IH, Nilsson C, Nilsson M, Eckerstrom M, Nordlund A, Nyberg L, Sunnerhagen KS, Svensson J, Terzis B, Wahlund LO, Georg Kuhn H. Cognitive medicine - a new approach in health care science. BMC Psychiatry. 2018 Feb 8;18(1):42. doi: 10.1186/s12888-018-1615-0.

  PMID: 29422020 BACKGROUND

• Jessen F, Wolfsgruber S, Wiese B, Bickel H, Mosch E, Kaduszkiewicz H, Pentzek M, Riedel-Heller SG, Luck T, Fuchs A, Weyerer S, Werle J, van den Bussche H, Scherer M, Maier W, Wagner M; German Study on Aging, Cognition and Dementia in Primary Care Patients. AD dementia risk in late MCI, in early MCI, and in subjective memory impairment. Alzheimers Dement. 2014 Jan;10(1):76-83. doi: 10.1016/j.jalz.2012.09.017. Epub 2013 Jan 30.

  PMID: 23375567 BACKGROUND

• Winblad B, Palmer K, Kivipelto M, Jelic V, Fratiglioni L, Wahlund LO, Nordberg A, Backman L, Albert M, Almkvist O, Arai H, Basun H, Blennow K, de Leon M, DeCarli C, Erkinjuntti T, Giacobini E, Graff C, Hardy J, Jack C, Jorm A, Ritchie K, van Duijn C, Visser P, Petersen RC. Mild cognitive impairment--beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med. 2004 Sep;256(3):240-6. doi: 10.1111/j.1365-2796.2004.01380.x.

  PMID: 15324367 BACKGROUND

• Wicksell RK, Olsson GL, Hayes SC. Psychological flexibility as a mediator of improvement in Acceptance and Commitment Therapy for patients with chronic pain following whiplash. Eur J Pain. 2010 Nov;14(10):1059.e1-1059.e11. doi: 10.1016/j.ejpain.2010.05.001. Epub 2010 Jun 9.

  PMID: 20538493 BACKGROUND

• Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.

  PMID: 16300724 BACKGROUND

• Ekman U, Kemani MK, Wallert J, Wicksell RK, Holmstrom L, Ngandu T, Rennie A, Akenine U, Westman E, Kivipelto M. Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI): Study Protocol of a Randomized Controlled Trial. Front Psychol. 2020 Dec 23;11:600841. doi: 10.3389/fpsyg.2020.600841. eCollection 2020.

  PMID: 33424715 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Health Behavior

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Miia Kivipelto, Professor

  Karolinska Institutet

  STUDY DIRECTOR

Central Study Contacts

Urban Ekman, PhD

CONTACT

+468-517 713 66; urban.ekman@ki.se

Måns Gyllenhammar, PhD student

CONTACT

+468-52483557; mans.gyllenhammar@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 22, 2020
• Study Start: September 7, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)